REACH Round Table Q&As:

Questions from 2008:

Annelie Struessmann, PhD

Annelie Struessmann, PhD

The REACH Round Table is an opportunity for cosmetic chemists, R&D managers and other industry professionals to submit questions and comments about the REACH legislation in Europe for response by expert Annelie Struessmann, PhD, of CONUSBAT (Aachen, Germany). Struessmann has more than 20 years of industry experience in regulatory affairs and product safety, application and product R&D and technical marketing.

Please Note:

This information on REACH is the opinion of participants of this website and is not meant to be used as a substitute for legal counsel. Allured Business Media assumes no liability for customer use of this information - see our Legal Terms for more information.

Q.Can we increase or decrease the tonnage band after Nov. 30, 2008 but before registration looking at current market conditions?
- Anonymous, December 03, 2008
A.Yes, you can and have to adjust the tonnage band with the actual situation of manufacture or import. That includes the consideration of a change in registration deadlines.
Q.Is REACH retroactive to articles currently in the EU or does it apply strictly going forward from Dec. 2?
- Anonymous, December 03, 2008
A.The REACH provisions for registration (and others) have applied since June 1, 2008. That means you have to be compliant as of that day.
Q.If we are a trading company that supplies final articles to importers in the EU, can we be held liable if the article elements are not registered?
- Anonymous, December 03, 2008
A.If you are trading articles that follow the REACH definition for articles, only substances intended to be released have to be registered. The importer is responsible for the registration.
Q.Which ingredients, those with EINECS or those with ELINCS, have to be pre-registered?
- Anonymous, December 03, 2008
A.Substances with EINECS numbers are phase-in substances and can be pre-registered. Substances with ELINCS numbers are considered as being registered.
Q.If a cosmetic ingredient already has EINECS, is pre-registration no longer needed?
- Caroline, December 03, 2008
A.No, the EINECS number makes the substance a phase-in substance, which has to be pre-registered by Dec. 1, 2008.
Q.After pre-registration phase is over, can we decrease or increase the tonnage band in the registration phase?
- Dr. Joishar, December 03, 2008
A.Yes, that is possible and needs to be done anytime a new tonnage band is reached. Be aware of the changing registration deadlines.
Q.We Import shoe care products from the Far East into the EU, each type likely to add up to more than 1000kg of an indivudual substance. For example, we use latex for insoles, TPE for gel insoles, PP for shoehorns and PU for shoe stretchers. Should these be pre-registered with ECHA? Also, obviously these products are packaged in plastic bags etc. Do we also need to know the polymers used in the packaging and register these too?
- Anonymous, December 03, 2008
A.It looks to me that you are importing articles (insoles). Therefore, the provisions for articles apply. The packaging is also considered as being an article. For articles, only substances intended to be released need to get registered. Also, be aware of the notification provisions for Substances of Very High Concern (SVHC).
Q.I work for an EU company. We buy raw materials pre-registered from the EU market and produce the following:

Preparations: We mix the components without chemical reaction and than add some solvents including acetone MEK and toluene. These type of preparation can release some solvents when used by professionals. Even if the solvents were registered by my supplier, do I need to pre-register them again or do we just need to make just a notification. If so, how and till when?

Phenolic resins: These are used for internal use to impregnate fabrics or papers, producing prepregs –partial cured articles and rigid laminates. Do we need to pre-register some monomers (partial condensation products) even we do not sell these on the market?

Resins: Including poyestherimide, gliptalic and alchidic resins which are thinned with solvents for producing varnishes. Do we need to pre-register some NLP for these varnishes. Is it ok to treat them as polymers?

Do we need to pre-register again the solvents that we take it from EU producer that will be released from the varnish during utilization.


- Silvia, December 03, 2008
A.You described that you are making preparations, so all substances in these preparations have to be registered within the provisions of REACH. If this is done by an actor up the supply chain, the substances do not need to be registered again, you only have to prove the status of registration with the statement of your supplier. The said includes the solvents.

It looks to me as if your phenolic resins are part of packaging, which is an article under REACH. Therefore ,the provisions for articles apply. If no substance is intended to be released, no registration applies but a notification may apply with regard to SVHCs.

With your resins again it looks to me as if you are making preparations, so the same applies as previously discussed. If some of the substances fall under the REACH definition of a polymer, then the monomers need to be registered (pre-registered); if some of the substances are NLPs, they have to be registered as such.

Q.I am confused with the registration of substance with multiple constituents. We are in the process of pre-registering tocotrienols through our OR. However, I am confused with their explanation. They mentioned that for our case, we should register tocotrienols and also each individual components of tocotrienols (alpha-, beta-, delta-, gamma-tocotrienol). Does it mean that we also allow to import individual component of tocotrienol on its own, e.g. alpha tocotrienol only? Do we need separate registration if we want to import each individual components on its own to the EU? If in the future we have another tocotrienol product, e.g. alpha tocotrienol acetate, do we need to register alpha tocotrienol acetate as a whole, do we need to register each individual components of alpha tocotrienol acetate separately or do we only register the acetic acid as alpha tocotrienol has already been registered previously?
- Ling, December 03, 2008
A.In order to be able to answer your questions properly, I would have to go into the details of your substances as obviously these are complex multi-constituent substances. Your OR certainly has done so as he or she, according to the REACH regulation, will be held legally responsible for fulfilling all provisions. As such, the OR will be able to answer all of your questions in a definite way. If you want to get further insights on how to pre-register multi-constituent substances you can get further background information from the Guidance on substance identification.
Q.I am an importer/distributor of natural substances for the cosmetic industry. Many of these natural substances are Generally Recognized as Safe (GRAS) food items that do not have EINCS or CAS numbers. I still don't know how to handle the REACH matter. Whould you advise using the generic EINECS for natural susbtances : 310-127-6?
- Berthet Alain, December 03, 2008
A.Generally, your substances need to comply with the chemical description given for an EINECS number. If the description is generic, often several EINECS numbers exist and describe a substance. However, there are substances without EINECS numbers and most often these are non-phasein substances and have to be registered immediately.

Many of your substances may be exempt from REACH provisions according to REACH Annex V(7, 8,9). However, they have to comply with the definitions under REACH. When exempt, according to Annex V, a chemical modification is excluded. Also EINECS 310-127-6 excludes a modification.

You may research the ESIS-European chemical Substances Information System to find an appropriate EINECS number for your substance.

Q.I am trader company from a non-EU country. I am selling cosmetic ingredients such as nail-polish varnish from an EU country to my customers. They are just mixing this varnish with colorant to make the finished product, i.e. nail-polish. The EU company is already registrating the varnish within REACH. Do my customers also register this product with REACH in our country?
- Rana Cakay, November 18, 2008
A.The substances forming the nail polish base do not need to be registered again upon re-import into the EU because they have been registered by an actor up the supply chain. The substances making the colorants, though, do need to be checked and registered if the import volume exceeds 1 ton/year. If the final nail polish is not imported into the EU, REACH does not apply at all.
Q.Are pharmaceutical excipients, eg. modified starch for binders in tableting, exempt from REACH registration? In my opionion, the regulation clearly states that excipients are exempt. However, as the pre-registration window is about to close, I am not as confident.
- Anonymous, November 18, 2008
A.REACH Article 2(5) clearly excludes substances used in medicinal products from registration and other titles as mentioned in the article. Therefore, pre-registration also does not apply.
Q.We send our product in a specially made container which is coated with paint made of lead and chrome. The qty of paint applied on the container is more than 1 ton/year. The product does not come in contact with the container. Should we change the paint?
- Deepak Joishar, November 10, 2008
A.I understand that you are not importing the paint into the EU as a paint product to be used as such; however, that the paint is part of your packaging. Packaging is an article under REACH and the provisions for an importer of articles applies to the paint coated container. The paint is most likely not intended to be released, therefore no registration applies to the paint on the container and, generally, no requirement exists to make changes.

You need to check if the substances are on the Candidate List of SVHC for Authorization (see ECHA Web site) are part of the paint. If yes, you need to fullfill the obligations resulting immediately and those applying at a later stage. If a substance on that list is in the paint, you will need to apply for authorization at some time later. The time frame can be found on ECHA's Web site. If an authorization would not be granted then, as a consequence, you would have to modify your paint.

You should also check if obligations under REACH exist for your product.
Q.I am a non-EU manufacturer exporting fragrances to the EU. If one or more of my ingredients only has an ELINCS number and this ingredient is exported more than 1 ton/year, does the EU importer need to pre-register this substance?
- Anonymous, November 10, 2008
A.If it is an ELINCS (European LIst of Notified Chemical Substances) number it means that the substance was notified in accordance with Directive 67/548/EEC which is regarded as a registration under REACH.
Q.Do you animate on-line courses about REACH?
- Beuss, November 03, 2008
A.Until the end of pre-registration, I am not providing any courses. Please tell about your specific interests, so we can plan for further courses.
Q.Can you tell me the EC number of sodium carboxymethyl cellulose?
- Eric, November 03, 2008
A.To the best of my knowledge, there is no EC number for CMC because it is a polymer.
Q.Does REACH replace the EU Cosmetic Directive or does one have to comply first with the EU directives before attempting to pre-register under REACH?
- Elram, November 03, 2008
A.REACH is chemical legislation and, as such, replacing the notification procedures and the Safety Data Sheet provisions of Directive 67/548/EEC (Dangerous Substances) and its amendments. The Classification and Labeling System of Directive 67/548/EEC will be substituted in the coming years by the implementation of the United Nations Globally Harmonised System (GHS)*

The Cosmetics Directive 76/768/EEC applies to cosmetics products; it is not affected by REACH in any of its provisions.

Cosmetic ingredients are chemicals; as such REACH applies to these.

Q.A raw material manufacturer produces 2 tons of a certain material per year and does not register it under REACH. Cosmetic company A uses 0.5 tons/year of the material whereas cosmetic company B uses 1.5tons/year of the material. Does this mean that only company B has to register, as their usage exceeds 1 ton/year?
- Anonymous, November 03, 2008
A.These scenarios must be imported into Europe for REACH regulation to apply. If all your actors are in Europe, only the manufacturer has to register, as the others are downstream users. If none of the companies are in Europe, only the quantity imported applies; many case scenarios are possible with quite different resulting responsibilities.
Q.For a biodiesel stabilizer, do we need to declare all the ingredients ?
- Jerrold Anchan, November 03, 2008
A.I do not know the details of biodiesel stabilizers. If it is a mixture of various substances, then it is a preparation in terms of REACH and each substance has to be registered. It may be a multi-constituent substance. The difference between preparation and multi-constituent substance is that a preparation is produced by blending two or more substances without chemical reactions whereas a multi-constituent substance is the result of a chemical reaction.

Please follow the definitions of the REACH regulation in Article 3, and for the registration of multi-constituent substances, see guidance for identification and naming of substances under REACH.

Q.Does REACH deal with raw material manufacturers only or does it apply to cosmetic manufacturers as well?
- Anonymous, November 03, 2008
A.Personal care products and all substances contained therein have to be registered/pre-registered within the provisions of REACH.
Q.How does the EU propose to enforce REACH? If your ingredient is less than one ton per year, how can authorities verify this. Do they take your word, or does one have to submit proof? It seems like a very difficult regulation to enforce especially in preparations.
- Dennis, November 03, 2008
A.Importers and ORs have to provide documentation on substances to the EU enforcement authorities upon request. Quantities are based on the three previous years before REACH was enacted. My documentation management tool is a substance inventory that contains all information requested. The enforcement control can be performed as of Dec. 2, 2008.
Q.If you have a non-phase-in ingredient that was not registered prior to June 1, 2008, and are not eligable to sell, can you resume selling once a inquiry dossier has been submitted and you have been assigned a submission number?
- Anonymous, November 03, 2008
A.Manufacturing or importing can resume within three weeks after the submission of the registration dossier if there is no indication to the contrary from the ECHA.
Q.We import finished product gift-with-purchases (GWPs) into the EU. What is our obligation under REACH?
- Anonymous, November 03, 2008
A.As the importer of goods into the EU, you have the obligation to register/pre-register the substances contained in your imported products, or to assure that these have been registered by an actor up the supply chain. First, identify if your products are preparations or articles under REACH, as the resulting obligations are different.
Q.Does alcohol that is used in cosmetics fall under REACH?
- Arshad, October 23, 2008
A.Yes, it does.
Q.You said flavors are exempt, but what about using a flavor in a cosmetic like a lipstick?
- Anonymous, October 23, 2008
A.Flavor in lipsticks is not exempt according REACH Article 2(5bii), as a flavoring in foodstuffs.
Q.Does REACH pre-registration include products like essential oils or oleoresins (spice extracts) used in food, pharma, cosmetic, toileteries, neutraceuticals, and perfumery industries?
- Sreenivasa Baliga, October 23, 2008
A.Ingredients in food and pharma products are exempt from registration (see Article 2). Neutraceuticals have to be within the scope of Council Directive 89/107/EEC (food additives) to be exempt. All quantities used in cosmetics and perfumery have to be registered/pre-registered.

Essentials oils may meet the exemption of Annex V(8): Substances occurring in nature …, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC.

Definition according to Article 3 (39) Substances which occur in nature: means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means;

Q.I know that if the ingredients in my formula undergo physical reaction, that I need to register only the ingredients, but if they undergo chemical reaction, that I need to register my finished product as well. Are shampoos & creams considered physical or chemical reactions?
- Anonymous, October 23, 2008
A.Personal care products are preparations in terms of REACH. Therefore, the substances in their formulations need to be registered/pre-registered. Have in mind an ingredient is often a preparation consisting of several substances.
Q.We are a non-EU company manufacturing product for non-EU customer. This non-EU customer sells product in EU and has asked us to fulfill REACH obligations. Do we need to fulfill REACH obligations? If yes, then what should be tonnage band? Would that be the quantity of substnace sold to non-EU manufacturer or would it be total quantity of the substance that is exported by our customer in EU?
- Ann, October 23, 2008
A.You don't need to fulfill REACH obligations because the importer is responsible by law. However, your customer may decide to change to a supplier that provides pre-registration/registration. This is a business decision for you. As for your second question, the quantity that is imported into the EU. However, REACH works with tonnage thresholds.
Q.If a chemical does not have an EINCES number, does this mean it cannot be pre-registered under the "phase-in" chemicals. What is the process for these non-phase in chemicals?
- Janis, October 23, 2008
A.There are three different criteria for a phase-in status of a substance:
  1. It is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS)
  2. It was manufactured in the Community but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation
  3. It was placed on the market in the Community before entry into force of REACH Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in REACH regulation.

If your substance does not meet any of these criteria, it is a non-phase in substance and has to be registered before it can be manufactured in or imported into the EU. This obligation started on 1st June 2008. Prior to registration of such substances, the manufacturer or importer has a duty to make an inquiry to the Agency (Article 25) regarding any previous registration for that substance. Registration is the submission of a technical dossier and, if required, a chemical safety report to the European Chemicals Agency.

Q.We are a US contract manufacturer of finished cosmetic products. Two of our clients have stated that any raw material ingredients not preregistered or registered prior to Dec 1, 2008 may not be utilized in the formula of a cosmetic product being shipped into the EU. Further, that their products containing raw materials not pre-registered or registered by Dec. 1, 2008 will not be allowed into the EU and face siezure. Many of our raw material suppliers are in the process of pre-registration and do not have relevant information or numbers at this time. Also, REACH does not intend to publish its list of raw materials until 2009. Are my clients correct as to the timing of the raw material ban? How to I proceed as a contract manufacturer?
- Richard, October 23, 2008
A.Your clients are correct provided the substances in the products are imported in quantities of 1 ton or more. However, as exact quantities are often difficult to be obtained, they generally require pre-registration/registration commitment from the upstream suppliers.

Before the end of the pre-registration phase, I recommend getting a written statement from your ingredient suppliers with their pre-registration/registration commitment and to add that to your substance inventory. With that, you and your clients become downstream users and do not need to pre-register self respectively through an OR. For any future ingredient supply, I recommend to include in the purchase contract the supplier information on registration commitment for the respective ingredient composition with EINECS and pre-registration numbers.

The supplier companies have different policies on providing the pre-registration numbers. There is no legal requirement to communicate this within the supply chain. As the provision of the number by a supplier does not guarantee future compliance with REACH or continuity of supply, the written information on pre-registration with EINECS and the information on anticipated registration is my mandatory request.

Q.My problem is about the authorization procedure of cosmetic ingredients. When will authorization process start for an ingredient? Will it start after the registration dossier submitted to ECHA? Or will this process start during before pre-registration? Best regards
- Istanbul, October 23, 2008
A.Authorization is a long process. When an authority (commission or member state) considers that a substance may meet the criteria for identification as a substance of very high concern (SVHC), the authority will prepare an Annex XV dossier. Following completion of an Annex XV dossier, the substance may be included in the candidate list for possible inclusion in Annex XIV (List of Substances Subject to Authorization). Once the candidate list is established, some substances of very high concern will be prioritized.

ECHA shall make its first recommendation of priority substances from the candidate list to be included in Annex XIV of the REACH Regulation by June 1, 2009. The agency shall make further recommendations on substances to be included to Annex XIV at least every second year. Priority will normally be given to substances with PBT or vPvB properties that have a wide dispersive use or are manufactured or imported in high volumes.

Cosmetic ingredients are also regulated under the EU Council Directive (76/768/EEC) and the Cosmetics Directive. According to Article 4b, the use of substances classified as carcinogenic, mutagenic or toxic for reproduction is prohibited; therefore, I do not expect authorization procedures for cosmetic ingredients.

Q.As a non-EU manufacturer, we sell a substances from natural mineral(as a raw material) to non-EU companies who then sell their product to their own customer in EU. Who is responsible to register under REACH?
- Bahis, October 23, 2008
A.The importer into Europe is responsible for registration. However, when a substance has been pre-registered/registered by an actor up the supply chain, the importer does not need to pre-register/register the substance again.The importer becomes a downstream user in terms of REACH. The European Chemicals Agency recommends to downstream users: to contact their suppliers as soon as possible and well before the end of the pre-registration period (Dec. 1, 2008) in order to find out about the supplier’s intentions or, where necessary, look for alternative future suppliers.

Therefore, as the manufacturer, you are the highest in the supply chain and asked to do the pre-registration/registration of a non-EU manufacturer through an Only Representative.

You should check if your substance qualifies for an exemption according to Annex V(7). Substances which occur in nature, if they are not chemically modified include: Minerals, ores, ore concentrates, raw and processed natural gas, crude oil, coal.

Q.I export cosmetic products to the EU market. Our contract manufactuer in the US told me that one of the raw materials will not be pre-registered. I will not use the material that won't be pre-registered more than 1 ton/year. Am I required to do anything regarding REACH regulation?
- Anonymous, October 23, 2008
A.I assume that you are the importer in terms of REACH. I recommend maintaining a substance inventory as documentation tool with information on product ingredients, ingredient composition and the respective EINECS and pre-registration/registration information. As only substances manufactured in or imported into the Community in quantities of 1 ton or more per registrant per year have to be pre-registered/registered, it looks to me that you are REACH compliant.
Q.We are a distributor of cosmetic products to Europe. Do we need to specify where the product is made if it is not the same as where it is distributed from?
- Jia, October 23, 2008
A.As a first step, you have to determine your role within REACH. It looks to me like you are an importer of cosmetic products; this is the case if you import products from a non-EU manufacturer into the EU. The importer is responsible for pre-registration/registration of substances; in your case the substances the cosmetic products are made of. For the steps, pre-registration and registration, the non-EU manufacturers’ locations do not need to be disclosed. The registrant and a potential third party representative should be disclosed.
Q.A a non-EU supplier of finished cosmetic goods in a retail saleable form are we exempt from REACH. I take this opinion from the following statement.

There is some relief from the full requirements of REACH for the cosmetics and personal care industry. REACH states in Article 2.6 that:

"The provisions of Title IV (Information in the supply chain) shall not apply to the following preparations in the finished state, intended for the final user: (a) medicinal products (b) cosmetic products as defined in Directive 76/768/EEC."


- Helen, October 23, 2008

A.You are not exempt, as a non-EU manufacturer in first hand you have no obligations within REACH. However, your importer of products into the EU does:

Article 6(1): Save where this regulation provides otherwise, any manufacturer or importer of a substance, either on its own or in one or more preparation(s), in quantities of one ton or more per year shall submit a registration to the agency.

Article 2(6) applies only to the REACH provisions of Title IV – Information in the Supply Chain.

Q.I represent a plastic processing company in the US. We purchase plastic resin from domestic suppliers and mold it the resin into various parts. A small portion (under 1 ton) of these parts are purchased by EU companies. Am I exempt? If so, do I need to do anything to prove it or can I simply give my EU customers a verbal answer
- Dan D., October 23, 2008
A.As a non-EU manufacturer, you have no obligations; however, your importer would be responsible for the registration of the monomers, other reacted substances and unbound additives that do not function as stabilizers within the provisions of REACH (I assume your product is a polymer, see the REACH definition for polymers in Article 3(5)).

Clearly your importer(s) must be aware of the quantities they have REACH obligations for. As you say, the total tonnage of resin imported into the EU from your supply is below 1 ton/year and the tonnages for the educts and additives are even smaller. As registration applies only to substances manufactured or imported in quantities of 1 ton/year or more, your importer is not exempt, but the import tonnages are below the threshold for registration requirements. However, if your importers import the same substances from other suppliers, they would have to add the quantities, and if they then result in totals > 1 ton, they would need to pre-register/register.

Now the scenario most often is that importers ask their suppliers for pre-registration. If you would answer that you would not do so (you could pre-register/register through an Only Representative) than the consequence can be that your customers would look for an alternative supplier who has pre-registered/registered. Thus, a business decision may need to be made.

Q.I am a cosmetic manufacturer that uses several chemicals in our preparations, which a small percentage are exported to the EU market. Our chemical suppliers have confirmed that they are pre-registering their chemicals. Do I also need to pre-register the same chemicals to be compliant? Right now I am contacting them and, where possible, obtaining the registration numbers and Only Representative names they are using. Is this sufficient>?
- Jessica Russel, October 23, 2008
A.Based on communications from the ECHA and discussions within industry associations, I recommend to do exactly what you are doing and to add the written statement of the ingredient suppliers before the end of the pre-registration phase to the substance inventory. With that, your importer into the EU becomes a downstream user; neither the importing entity nor you through an OR need to pre-register self. For any future ingredient supply, I recommend to include in the purchase contract the supplier information on registration commitment for the respective ingredient composition with EINECS and pre-registration numbers. The supplier companies have different policies on providing the pre-registration numbers.There is no legal requirement to communicate this within the supply chain. As the provision of the number by a supplier does not guarantee future compliance with REACH or continuity of supply the written information on pre-registration with EINECS and the information on anticipated registration is my mandatory request.
Q.One of the raw material suppliers told me that they will not pre-register their material. They also told me we have to pre-register this material ourselves if we have to. If we use this material less than 1 ton/year, are we exempt?. Thank you.
- Anonymous, October 23, 2008
A.Registration/pre-registration applies only to substances manufactured or imported in quantities of 1 ton/year or more. If your import volume per substance is lower, you are not exempt; however, the import tonnages are below the threshold for registration requirements.
Q.I am about to start exporting sunsceen into Europe from New Zealand. It is likely that in total, the exports will be over one ton/year. Do we have to pre-register all the ingredients in the sunscreen? Also, is the UK seperate to all of this? Thanks!
- M. Power, October 14, 2008
A.As you are starting to import into the EU, you will have to pre-register at that moment when the tonnage per substance in your product exceeds 1ton/year, according to Article 28 [6] within six months after first import over the threshold, and not later than 12 months before the relevant deadline for registration. Have in mind, ingredients may consist of more than one substance; the definition of the REACH regulation for substances applies. Pre-registration is extending the deadline for registration.

One option is to use the raw materials from ingredient suppliers that pre-registered/registered the substances in their products, so you do not need to register yourself.

The UK is a country of the European Union, and as such, REACH applies.

Q.We are manufacturers and exporters of Mentha oil which is obtained by steam distillation of Mentha arvensis leaves.We also export crystals made out of the mentha arvensis oil and peppermint oil made out of fractional distillation of mentha arvensis oil. should we take reach registration. What is the procedure for the REACH registration?
- JK, October 14, 2008
A.From what you are describing, your product Mentha arvensis leaf oil seems to comply with the REACH definition:

Article 3(39): Substances which occur in nature - means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means.

As such it is exempt from registration according to ANNEX V(8): Substances which occur in nature other than those listed under paragraph seven, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC or unless they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or unless they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f).

I assume that the crystals you are mentioning are d,l-methol, EC-Number: 201-939-0. As these have been obtained through the fractionation of the natural oil and as they are not exempt in any other article of REACH, they fall under REACH and would have to be registered/pre-registered within the provisions or the regulation

Q.We are a non-EU company who exports several preparations that contain polymers as ingredients. Our formulas are proprietary information. If our sole importer assumes the pre-registration and registration responsibilities, is it sufficient for us to provide them with a list of substances that exceed the 1 ton minimum and their volumes without disclosing which of our products contain which substance? If monomers are pre-registered by upstream supplier, do they need to include the tonnages of our exports?
- Anonymous, October 14, 2008
A.Part 1: I have to answer this by citing the ECHA Guidance on Registration (p 47)

It is recognized that in the case of import of a preparation, it can be difficult to obtain information on the composition of the preparation from the non-EU supplier. However, also under existing community legislation (e.g. for classification and labelling of preparations) importers need to know which substances are present in the preparations being imported to be sure they are complying with the law. It will be up to companies to improve the communication through their supply chain to ensure their compliance with REACH. In case disclosure of the composition of the preparation may have consequences, the non EU exporter has the possibility to appoint an only representative, as explained in section 1.5.3.4.

Part 2: The upstream supplier has to include the tonnage that you are exporting to the EU in your preparations/polymers in preparations in his pre-registration/registration. It is recommended to contact the suppliers as soon as possible and well before the end of the pre-registration period (Dec. 1, 2008) in order to find out about their intentions and, where necessary, look for alternative future suppliers.

Q.For the 'lead' in lead pencil, which is a mixture of clay, graphite, sodium carboxymethyl cellulose and 1,2-ethanediol homopolymer, heated together at >1000 degrees celsius and then dipped in tallow, is it considered a preparation or is the whole pencil itself considered an article with intended release? Should I register all the materials?
- Anonymous, October 14, 2008
A.A pencil is a preparation in a container, and all substances of the preparation have to be pre-registered/registered within the provisions of REACH. The container (wood) is an article under REACH.

Different to earlier communications from RIP 3.8, the ECHA Guidance for Articles/May 2005 states in Appendix 1(4): If an object merely acts as a container/carrier material to deliver a substance/preparation (such as a spray can with a preparation in it, a printer cartridge, a pen, a cleaning tissue containing chemicals, ink in a printed ribbon or on carbon paper etc.) then it is a substance/preparation in a container and not an article.

This decision resulted from different classification and labelling requirements for substances and articles: EU suppliers of substances (on their own or in preparations) have to communicate information according to Article 32 or via safety data sheets. Article suppliers (producers/importers/distributors) normally have no legal obligation to communicate information on substances contained in their articles apart from the obligation in Article 33 under REACH. However, care must be taken as decisions made in relation to the definition of an object being a substance/preparation in a container which then may require classification and labelling as well as safety data sheets.

Q.I export cosmetics to the EU market. All raw materials used in our products will be pre-registered by raw material suppliers except one raw material. Our usage of that material will never pass 1 ton/ year. Do I have to pre-register it?
- Anonymous, October 14, 2008
A.No, because you are below the minimum threshold for registration. Just document everything thoroughly in your substance inventory.
Q.Are the following preparations or preparations in articles? 1. colour pencils (no perfume) 2. crayons (no perfume) 3. candles (no perfume) Thanks very much.
- Anonymous, October 14, 2008
A.Color pencils (no perfume): A preparation in a container and all substances of the preparation have to be pre-registered/registered within the provisions of REACH. The container (wood/polymer) is an article under REACH.*

Crayons (no perfume): See above

Candles (no perfume): The competent committee has not yet made a decision on candles, in cases like this the recommendation applies to pre-register the substances contained within the provisions of REACH.

*Different to earlier communications from RIP 3.8, the ECHA Guidance for Articles/May 2005 states in Appendix 1(4): If an object merely acts as a container/carrier material to deliver a substance/preparation (such as a spray can with a preparation in it, a printer cartridge, a pen, a cleaning tissue containing chemicals, ink in a printed ribbon or on carbon paper etc.) then it is a substance/preparation in a container and not an article.

This decision resulted from different classification and labelling requirements for substances and articles: EU suppliers of substances (on their own or in preparations) have to communicate information according to Article 32 or via safety data sheets. Article suppliers (producers/importers/distributors) normally have no legal obligation to communicate information on substances contained in their articles apart from the obligation in Article 33 under REACH. However care must be taken as decisions made in relation to the definition of an object being a substance/preparation in a container which then may require classification and labelling as well as safety data sheets.

Q.We are non EU manufacturer for cosmetics but we export our products to Europe. Our main ingredients are from EU companies. What are our obligations under REACH?
- Anonymous, October 14, 2008
A.When importing your products into the EU, all substances your products consist of have to be registered. Have in mind that ingredients may consist of more than one substance. Those ingredients you buy from EU companies are most likely registered/pre-registered; however, you should get a registration commitment from all your suppliers. Substances that have been registered by an actor up the supply chain do not need to be registered by you again.
Q.I represent a small cosmetics company who imports into the EU. Currently we do not pass the 1tonne/annum threshold for our raw materials, however we have been forecasted to exceed this threshold within the next 10 years. Do we still need to pre-register before November 2008? If we do not pre-register what are the consequences once we do pass this threshold? Thank you for your assistance.
- M. Clark, September 30, 2008
A.You have several options to comply with REACH. You definitely need to take action when exceeding the 1 ton threshold/substance. One option is to use the raw materials from ingredient suppliers that pre-registered/registered the substances in their products, so you do not need to register yourself. Another options is to pre-register at that moment when the threshold is reached (Article 28 [6]) within six months after first import over the threshold, and not later than 12 months before the relevant deadline for registration. Generally, acc. to the REACH regulation, you may pre-register as importer within the deadline until Nov. 30, 2008. Have in mind, pre-registration is extending the deadline for registration, substances imported above the threshold have to be registered when reaching the relevant registration deadline. Consequently, you may as well register before reaching the tonnage threshold. It is your judgement how to proceed best, which, as it seems to me, is to chose the first option described and prepare for this by corresponding with your supplier in due time.
Q.What are various tests for flavours
- Apeksha, September 30, 2008
A.Flavours are exempt from registration (Article 2[4b, ii]); consequently no testing under REACH applies here.
Q.Our non-EU affiliated company both blends chemicals and supplies the blends to us to supply our customers within the EU or for us to use in services performed within the EU. It also supplies us with chemicals which it has obtained from non-EU suppliers but which it repackages as its own. Can the Non-EU company be considered a manufacturer or formulator and can it appoint us as its affiliate as an Only Representative for all the above scenarios?
- Anonymous, September 30, 2008
A.Yes, according to Article 8 (1) a natural or legal person established outside the community who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an article that is imported into the community can nominate an only representative located within the EU to carry out the required registration of the substances imported into the community.
Q.We export finished cosmetics to all countries in the EU. What places (if any) require the registration of the products before sale. We do realize that a PIP must be prepared and be on file.
- Mark, September 30, 2008
A.Not your products; however since June 1, 2008, the ingredient substances of cosmetic products have to be registered (pre-registered) when imported into the EU markets (28 countries of the European Union, Iceland, Norway and Liechtenstein). The product information file is a requirement of the EU Cosmetics Directive; registration is a requirement of REACH (Chemicals Regulation) and applies additionally.
Q.We use raw materials exported from Germany to the United States in our personal care products, but they are far less than 1 ton. How do we stand with respect to REACH?
- VS, September 30, 2008
A.You are in good shape, because these ingredients you bought from a German supplier had to be registered (pre-registered) by the manufacturer. Unless you re-import these in your personal care product back into the European Union, you comply fully with the REACH provisions. You have to make sure that all your ingredients are pre-registered, getting the registration confirmation from your other, non-EU suppliers.
Q.If a supplier of foam responds to our request that there chemical composition is a trade secret.What is our responsibility to our customer with regards to reach requests. Is it enough to make sure the items we buy do not contain the 16 item precandidate list.
- Anonymous, September 30, 2008
A.I have to assume that the foam is an article under REACH and no substance contained is intended to be released. Each recipient must be informed of the presence of a substance in an article which is on the candidate list of SVHCs immediately after a substance is put on that list, within the provisions of REACH. Also, suitable measures for safe handling if relevant have to be provided. Such information considers the entire life cycle of the article, including the supply chain. You have to get the information from your supplier and have to provide the information to your customer, etc.

The importer of the article into Europe has to notify the authorities latest 6 months after the SVHC has been put on the candidate list, within the provisions of REACH starting June 1, 2011. Neither registration nor notification is required if the substance has already been registered for that use, or the producer or importer can exclude exposure of the substances to humans or the environment during normal or reasonable foreseeable conditions of use including disposal.

Q.We are thinking about selling cosmetic products into the EU. Do we pre-register all of our ingredients even though our products will contribute less than one ton of each ing./year?
- Small Business, September 30, 2008
A.Your questions has to be approached with business considerations, and I can only give you my personal opinion. I would compile a substance inventory with all qualitative and quantitative information and with that I would contact my ingredient suppliers and ask them about their REACH approaches. My goal for the future, when importing into the EU, would be to choose suppliers that fufill the REACH registration provisions for their ingredients, so in no way I would not need to register myself.
Q.If there is no heavy metals(or still under limited of EN 71 part 3) in printing inks on corrugated box and no SHVC in the Inks or in the box itself listed, should the box (packaging) be pre-registered under REACH?
- Hadi, September 30, 2008
A.A corrugated box with prints is clearly an article under REACH, the provisions for articles apply:

Registration applies if the article contains a substance which is intended to be released.

Notification applies if a substance is contained which is subject to authorization (SVHC).

For what you are describing, none of the provisions applies to you. I do not see registration (pre-registration) needs for you.

Q.With the modification of annex V, vegetable oils and waxes will be exempted. Is there a possibility that this draft will not be approved?
- Sandra, September 30, 2008
A.The ECHA informs: It is foreseen that the adoption of this proposal will take place in September or October 2008. Companies concerned by these changes are advised to carefully check the ECHA Web site during these months and, if appropriate, to pre-register their substances by Dec. 1, 2008. In case of doubt, it is recommended rather to pre-register the substance than to potentially face the consequence of having to register the substance before manufacturing or importing can continue. Pre-registration does not trigger any registration obligations and is free of charge.

I always recommend exactly following this advice (and do act myself accordingly).

Q.In a few places the REACH regulation says "without prejudice" to another directive. What does it mean?
- Anonymous, September 30, 2008
A.This means that REACH is not overriding any of the other legislations mentioned (directives, regulations, etc.), they apply additionally and fully. For those in the personal care sector it is important that we have to comply with the Cosmetics Directive as well as with REACH and others.
Q.As a supplier of articles, when does communication to consumers and customers downstream on articles contining SVHC begin? Do I need to prepare for any possible SVHCs that I am aware of in the article or do I only need to worry about SVHCs on the confirmed Candidate List?
- Anonymous, September 30, 2008
A.Article 7(7) of the REACH regulation states that a notification of SVHC in articles shall be made at the latest 6 months after the SVHC has been put on the candidate list for authorization but only as of June 1, 2011. The information that a substance from the candidate list is contained in an article has to be given by the supplier to the recipients of the article immediately after a substance is put in that list (Article 33).
Q.We are soap and shampoo manufacturers. We boil various natural oils like palm oil, coconut oil, mohua oil with NaOH/NaCl to obtain purified fatty acids from these oils. Then this extracted fatty acid is reacted with other chemicals like citric acid, benzyl benzoate, citronellol, eugenol, etc. to form a soap cake and we add perfumes.

Basically soap manufacturing invloves chemical reaction. We sell them as sandalwood soap, peach soap, coconut soap, etc. How do we pre-register/register our soaps within REACH?
- SRR, September 30, 2008

A.You are obviously dealing with UVCB substances or substances of unknown or variable composition, complex reaction products or biological materials, which cannot be sufficiently identified by their chemical composition, because:

◦ The number of constituents is relatively large and/or

◦ The composition is, to a significant part, unknown and/or

◦ The variability of composition is relatively large or poorly predictable.

As a consequence, UVCB substances require other types of information for their identification, in addition to what is known about their chemical composition.

In order to be able to identify your UVCB you will have to follow the instructions of the guidance for identification and naming of substances under REACH.

This guides you through the steps of identifiers and naming conventions to be able to assign EINECS numbers and prepare for pre-registration. This is quite a bit of a challenging work; however, you know your substance and that is the most important prerequisite.

Q.Dear Dr. Struessmann I have some questions on the information in the SDS supplied/received by non-EU suppliers:

Do the suppliers have any responsibility of carrying out the risk management measures as stated in any of the SDS supplied to them?

Do non-EU substance suppliers have the obligation to supply any risk management measures to their customers (may be direct customers or those a few supply chain steps away)in the EU?

Likewise, do the non-EU suppliers need to give information on exposure scenario in the SDS to customers in the EU?
- Stewart Walton, September 30, 2008

A.See Annex 1: General Provisions for Assessing Substances and Preparing Chemical Safety Reports (0.3). The chemical safety assessment of a manufacturer shall address the manufacture of a substance and all the identified uses.

It is, as usual for REACH, the importer that has this obligation within the provisions of REACH. If you use an OR, the OR has all responsibilities of an importer.

Q.As a non EU company, we import magnesium chloride hexahydrate as part of a desiccant. The quantity > 1 tpa. The company who makes the desiccant will not divulge the name of the chemical supplier but is checking with them (also non EU based). It ocurred to me that MgCl2 hydrate is a mineral. But I do not know the method of collection of the manufacturer. I have read on the Internet that it can be collected by means of evaporation from sea water. How would you recommend that I pursue this? I do not know enough about minerals to be sure it is exempt from registration under REACH. The company that makes the desiccant for us does not import into the EU so will not undertake the registration if required.

Also, do you have any advice about how to handle COLD PACKS used to ship product to Europe. I believe these COULD be interpreted as articles. The UK help desk wasn't sure and said for now to be safe and pre-register the chemicals involved. We use several suppliers. Most use polymers so we don't know the monomer make up. I find it hard to believe that everyone who uses cold packs will all independently have to pre-register these chemicals. But if the cold pack manufactures only sell to non EU companies, they won't take care of it.

Thank you for your help. I made read ALL the Q & A's on your site and think you have done an excellent job of providing guidance.
- Anonymous, September 30, 2008

A.Magnesium chloride hexahydrate: At first I would get more information on MgCl12. I recommend to see the IUCLID data sheet for a start. There the source is given as obtained by crystallization from mother liquor of sea water evaporation. I doubt that it is a mineral and as such exempt from registration; however, it could be considered a substance which occurs in nature and be exempt as such. I would call a supplier or an industry association and ask for their opinion, including their position on REACH. Also, I would contact my supplier and insist of getting good information about the source of the substance and the resulting pre-registration/registration situation. If I would not get sufficient information, I would consider a change of supplier to one that provides sufficient information and, if necessary, pre-registration/registration commitment. If needed in order to gain enough time to make all necessary steps, I would consider to pre-register the substance myself, as non-EU company through an Only Representative and deactivate the pre-registration when the legal status will be clarified.

Cold packs: I know cold packs (or hot packs) only from pharmaceutical applications or the first as cooler bag utensils. From this I understand that they are articles, objects which during production is given a special shape, surface or design which determines its function to a greater degree than does the chemical composition. Also, I do not see any intention to release a substance from the article. Therefore no registration obligations exist, maybe notification requirements do, see REACH Regulation Article 7(2+3) for these.

Thank you for your kind acknowledgement.

Q.Dear Annelie. The roundtable is one of the most usufull tools I found for REACH updating. Can you give the exact R - S /hazard symbols for SVHC's different categories?
- Anonymous, September 30, 2008
A.Many thanks for your acknowledgement.

Substances of very high concern are defined in Article 57 the REACH regulation. This includes substances which are:

• Carcinogenic, Mutagenic or toxic to Reproduction (CMR), meeting the criteria for classification in category 1 or 2 in accordance with Directive 67/548/EEC, and/or

• Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, and/or

• Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to human health or the environment of an equivalent level of concern as those above (e.g. endocrine disrupters)

The classification and labeling has to follow the identified risks of the substances. See for example some of the Annex XV reports from the ECHA candidate list.

CMR: 4,4’-Diaminodiphenylmethan, Carc. Cat.2; R45 (May cause cancer), Muta. Cat.3; R68 (Possible risk of irreversible effects), T; R39/23/24/25 (danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed), Xn; R48/20/21/22 (Harmful: danger of serious damage to health by prolonged exposure) R43 (May cause sensitization by skin contact), N; R51-53 (Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment)

CMR: Dibutyl phthalate (DBP), Repr. Cat. 2; R61 (May cause harm to the unborn child), Repr. Cat. 3; R62 (Possible risk of impaired fertility), N; R50 (Dangerous for the environment: very toxic to aquatic organisms)

PBT: Alkanes, C10-13, chloro, N: R50-53 (very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment), Xn: Carc. Cat. 3; R40 (Limited evidence of a carcinogenic effect)

Q.This question is regarding SVHC's and article producers. We produce cosmetics and would like to make sure that our packaging suppliers are OK with REACH. Assuming that the packaging suppliers are not realizing any substance, the suppliers have to relate to the SVHC's notification requirement only. The problem is that the SVHC's lists haven't been published yet, so they cannot guarantee they do not use SVHC's at any level.
- Anonymous, September 30, 2008
A.Substances of very high concern (SVHC) in articles require notification [Article 7(2)] when the following conditions are met:

◦ the substance has been included in a candidate list for eventual inclusion in the list of substances subject to authorisation (Annex XIV)

◦ the substance is present in those articles above a concentration of 0.1% weight by weight (w/w)

◦ the total amount in those articles exceeds one tonne per producer or importer per year

◦ the substance has not yet been registered for that specific use.

However, there is no obligation to notify if the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use and disposal. In such cases, the producer or importer has to supply appropriate instructions to the recipient of the article.

Article 7(7) of the REACH regulation says that a notification of SVHC in articles shall be made at the latest 6 months after the SVHC has been put on the candidate list for authorization and by June 1, 2011. The information that a substance from the candidate list is contained in an article has to be given by the supplier to the recipients of the article immediately after a substance is put in that list (Article 33).

The candidate list will be updated continuously when substances have been identified as meeting the criteria of Article 57 of the REACH regulation. A first list of "Proposals for identification of Substances of Very High Concern to be placed on the candidate list" is published on the ECHA Web site.

Q.We produce cosmetic products. We use some food raw materials like honey and yoghurt in some of our formulations. Do these raw materials have to be registered? Thanks in advance.
- Mark Karaiskos, September 30, 2008
A.When using these substances in cosmetic products the quantities used for this fall under REACH. However you should check if they comply with the definition for naturals (Article 3(39) - substances which occur in nature. If yes, they are exempt from registration according to Annex V(8).
Q.Dear Annelie, We are trying to understand if we should set up the only representative in EU or go with using importer in each country we sell to. Can you possibly go through advantages and disadvantages of each option? Also, can you please let us know in what section of REACH regulations we can find this information? Thank you.
- Anonymous, September 30, 2008
A.There are the facts and there are considerations of potential business consequences.

The facts when appointing an OR include that the non-EU manufacturer:

• is not bound to the European importer – can change a distributor without consequences for the pre-registration status;

• cooperates with only one REACH focal point – not with several distributors or importers into the EU, incl. non-EU clients importing substances with their consumer products;

• does not disclose confidential data to distributors, may incl. sales and client information or data on substance and product composition.

I personally do not see any disadvantage for using an only representative; the position is independent from other business considerations.

With getting the experience of pre-registration the degree of mutual understanding and trust necessary between the non-EU manufacturer and the representing pre-registrant becomes obvious. The pre-registration is only assigned to the pre-registrant, there is no correlation made to the name of the non-EU manufacturer during procedures in REACH-IT. This means that all rights on the pre-registration go to the pre-registrant.

The decision on how to pre-register requires diligent, comprehensive business oriented considerations.

The information on OR is laid down in Article 8 (REACH Regulation). Further interpretations are found in the Guidance on registration, section 1.5.3.4.

Q.If a substance is listed on Annex IV as exempt from REACH registration, and it is used in cosmetic application, does the exemption not apply?
- Confused, September 09, 2008
A.Confusion applies to all of us, once in a while, but usually an answer is found through discussion with experts or reading a guidance document.

The exemptions of the Annexes IV and V refer to the substances mentioned. As such they apply to all applications, or uses according to REACH terminology, with obligations to register, including the use as cosmetic ingredients.

Q.We are an aroma chemical manufacturer from India and we export the following products above 100 tons per annum to Europe: Benzyl acetate, benzyl benzoate, cinnamaldehyde and cinnamic alcohol. These products are synthetic substances used in making flavors and fragrances. They are identified as flavoring substances by JECFA and by EU Cosmetic Directive. Is there any exemption applicable? Do we need to pre-register if exempted. Only pre-registration is sufficient (Registration not required).
- M.Prabhakar and K.Prashant, September 09, 2008
A.Article 2(5b,ii) exempts flavorings in foodstuffs within the scope of Council Directive 88/388/EEC of June 22, 1988, from several provisions of REACH, including registration (as such pre-registration). If your substances are used as fragrance components in cosmetics, then the quantities used for this application have to be registered as they are phase-in substances in an immediate step they have to be pre-registered when exceeding import quantities of 1 ton/year. A pre-registration is allowing for an extended time frame to perform the registration; however, the registration is the legal request for performing business in the European Union.
Q.We are non EU Oral care product manufacturer. What is procedure of pre-registration of our preparations?
- AA, September 09, 2008
A.Consumer products do not need to be registered; however, the ingredients and the substances forming the ingredients should be. You should contact your suppliers and ask them about their registration policies. Get a written confirmation that they do intend to pre-register and subsequently will register their substances and that they include the tonnages you are using in their registration. If your suppliers do not intend to register, you may do so yourself using an only representative or look for an alternative supplier.
Q.If a momomer has been registered by a non-EU manufacturer, through an Only Representative, and that monomer is used by a second non-EU manufacturer to make a polymer, does the second non-EU manufacturer also need to register the monomer, or is the registration by the first manufacturer considered to be 'up the supply chain'?
- Anonymous, September 09, 2008
A.Reach requires to think in tonnages. If the non-EU manufacturer of monomers included the tonnage in his registration that the non-EU manufacturer of the polymer is using for his polymerization, then the non-EU manufacturer of the polymer is an actor down the supply chain and does not need to register him/herself. He/she should get in touch with the supplier of the monomer to make sure that his/her tonnage is included in the registration/pre-registration. As a proof, he/she should request the correlated ECHA-reference number.
Q.Coming back on the decals question I asked on Aug. 21, 2008, when you say you do not believe that this (intended to be released) applies to decals, that´s really my point, because decals are used to print on ceramics (or glass). Is this considered intended release? Like you say, paint from a cartridge is, because is to print on paper.
- Sílvia Alegre, September 09, 2008
A.Guidance for Articles: The question, “Is it wanted that a substance/preparation is released from the article during its normal and reasonably foreseeable use because this is necessary for it to fulfil a certain function of the article?” should be answered with yes. Intended releases are deliberately planned and have a specific function for the article, which frequently is not the main but an accessory function of the object.

With the information you have provided, I come to the conclusion that you have an intended release or a preparation in a special container. In both cases, a registration of the substances results. When answering last time, I had been under the impression that a decal goes in total to the ceramic piece, including the carrier of the substances which will form the print.

Q.Thank you very much for answering my polymer question, Annelie. What about preservatives and other additives in our polymeric emulsions: should we register them if we do not manufacture them?
- Yelena Zolotarsky, September 09, 2008
A.The registration requirements for polymers include:

◦ Reacted monomer

◦ Other reacted substances

◦ Unbound additives which do not function as stabilizers

A preservative is not considered a stabilizer, as the microbiological degradation can be prevented differently. A stabilizer would be e.g. an additive to stop a chemical reaction which would happen spontaneously without a stabilizer. Therefore, preservatives in polymer preparations have to be registered or pre-registered by the manufacturer or the importer in the EU.

If you do not manufacture them yourself, REACH applies to you. You should ask the actor up the supply chain such as your supplier, if they or a higher up actor does or did so and get the pre-registration or registration number.

Q.Some food colors, i.e. food dyestuff, are used as colorant of inks (water based inks) as I mentioned previously. These include tartrazin, brilliant blue, Ponceau 4R, etc. They have C.I. numbers and EEC numbers. Are they exempt from REACH ?
- Hadi, September 09, 2008
A.The use as food additive is explicitly exempt from registration obligations in the REACH regulation so that there is no confusion with the mission of the European Food Safety Authority (EFSA) (use is the REACH term for what is often called application). However, when used as ingredient in personal care products, the colorants have to be registered, as this use is not exempt from registration under REACH.
Q.As a non-EU manufacturer, we have several substances in our preparations that are not intended for cosmetic applications that do not have EINCES,ELINCS or NLP numbers, but are listed on the Cosmetics Directive - 76/768/EEC. Can we pre-register and subsequesntly register these substances even though they do not have an EINCES number and are not used in cosmetics? Do we have a duty to inquire with ECHA?
- Gary, September 09, 2008
A.The Cosmetics Directive and REACH are two European regulatory frameworks that act independently from one another. The Cosmetics Directive is geared towards personal care consumer products, whereas REACH is chemical legislation. As chemicals are used as ingredients for personal care products, REACH applies to the ingredients. REACH applies to almost all other application areas where chemicals are used. In REACH, the term for application is USE (see Article 3 (24). So you can (have to) register substances no matter what the use of your substances is.

If you want to pre-register your substances, they have to be phase-in substances and comply with the REACH definition for these (see Article 3 (20):

(a) it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);

(b) it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this; L 136/20 EN Official Journal of the European Union 29.5.2007

(c) it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this.

I recommend researching in ESIS if your substances are described with EINECS numbers. You can see the guidance for identification and naming of substances in REACH on the ECHA website. The duty to inquire applies only to non-phase-in substances and registrants of phase-in substances who have not pre-registered, so if your substances are indeed not covered by any of the definitions for phase-in substances, you need to register immediately.

Q.Is Honey exempt from REACH regulation?
- Anonymous, September 09, 2008
A.REACH applies to honey if it is used in cosmetics. However, you should check if your product fulfills the REACH definition for substances occurring in nature (Article 3 (39)) and would be exempt from registration according to Annex V.
Q.We are manufacturer of polymers. Are polymers exempt under REACH? If they are, do we still need to pre-register monomers or monomers manufacturer needs to pre-register them?
- Yelena Zolotarsky, August 25, 2008
A.Polymers are exempt if they fulfill the polymer definition given in the REACH regulation. If the monomers which build your polymers have been registered by an actor up the supply chain, e.g. the manufacturer, you do not need to register these again. If they have not been registered and you import the polymers into the EU, then it is your obligation to register the reacted monomers, other reacted substances and unbound additives which do not function as stabilizers.
Q.As a seller of decals for ceramic decoration, which are my obligations? Should I pre-register my product or any of the substances it contains?
- Sílvia Alegre, August 25, 2008
A.I am not familiar with the specifics of decals for ceramic decoration. However, I would approach it with the definition for articles (objects which during production is given a special shape, surface or design which determines its function). If you think that this definition applies to your products the following obligations result:

Registration and notification of substances in articles > Any producer or importer of articles shall submit a registration to the Agency if:

(a) the substance is present … in quantities totalling over one ton per producer or importer per year;

(b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.

If a substance is subject to authorization, then any producer or importer of articles shall notify the agency if both the following conditions are met:

(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;

(b) the substance is present in those articles above a concentration of 0,1% weight by weight (w/w).

If your products are articles, you have to take action if a substance is intended to be released. I do not believe that this applies to decals - intended to be released from an article is e.g. ink from a cartridge. You also have to identify if your colors contain highly dangerous substances. If yes, that would result in a notification need to the authorities.

Q.We have two different raw material suppliers of a certain material. One has pre-registered this material under REACH, but the other does not have an intention to pre-register. Can I still use this material from the supplier who will not pre-register since other supplier is registering this material?
- Anonymous, August 25, 2008
A.If you need to use registered raw materials because the obligations of REACH apply to you, than you have to make sure that all substances in the raw materials you use are registered. You cannot use a raw material of a second supplier who has neither registered nor pre-registered because the same raw material was registered by a different supplier.
Q.We are an exporter of polymers and plan to use an OR to preregister our monomers. If for any reason we are unable to meet the Dec. 1, 2008, pre-registration date, can our distributors continue to sell our products while we get registered?
- Anonymous, August 25, 2008
A.No. By Dec.1, 2008, the substances in your products have to be either pre-registered or registered. If not, you are not allowed to sell these into the European Union, and your customers are not allowed to use these substances.

See Guidance on data sharing: If a company fails (or does not wish) to pre-register within the applicable deadline (i.e. in most cases 1 December 2008), it will have to suspend its activities involving the substances concerned and register them without delay. In addition it should be remembered that in this case the registrant will also have to inquire at the ECHA if a registration for the substance has been made. All manufacturing, placing on the market and use of such substances between the start of the pre-registration deadline (i.e. in most cases 1 June 2008) and the date of suspension of activities may be subject to penalties according to national law. This also means that the downstream uses of these substances may be at risk. Activities involving the substances concerned can then only be resumed three weeks after the submission date of the a complete registration dossier.

Q.What is the status under REACH for materials obtained by fractionation of vegetable oil (ex : palm olein) or for a by-product from the refined vegetable oil (palm fatty acid distillate) used in soaps and detergents industry? Are they exempt for any registration ?
- PNT, August 25, 2008
A.The draft revised Annex V (9) was recently published on the ECHA Web site, and in addition to the former Annex V, the following is exempt from registration:

9. The following substances obtained from natural sources, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC with the exception of those only classified as flammable [R10], as a skin irritant [R38] or as an eye irritant [R36] or unless they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or unless they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f):

Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts; glycerol.

For your interpretation, if your substances comply with this exemption consider the following definition from the REACH Regulation Article 3 (40):

Not chemically modified substance: means a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities.

To my understanding this exemption in Annex V (9) applies to your palm olein as well as to palm fatty acids and their fractions.

Q.You kindly replied to my question of 30th June as to whether I should pre-register as the importer, only representative or third-party representative. In the meantime, I have successfully pre-registered a single substance, in this case ZnO. What surprised me (apart from how simple it was) was that I was not asked the question was my company pre-registering as importer, only representative or third-party representative. Which function does my company now fulfill? Also, surprisingly, I was not asked who the non-EU manufacturer was, nor in what application the product is used.
- Andrew Knox, August 25, 2008
A.You have to find out about your role in REACH in order to be able to determine if and what kind of responsibilities you have for REACH. For pre-registration, the ECHA wants some of the information consequential to your evaluation including: legal entity name, contact details and billing information. The legal entity may be a manufacturing/producing site, an importing site or an only representative. A third-party representative is not a legal entity for pre-registration; this is a position only for proceedings in SIEFs.The other issues you mention are of importance for registration.
Q.What is the status of bronopol as a biocide in cosmetics?
- Anonymous, August 15, 2008
A.Only biocides used in plant protection products, e.g. pesticides, are exempt from REACH. Biocides in cosmetic products have to be registered.
Q.Do we need to pre-register our packaging material which may include polyethylene laminated paper bags, polypropylene supersack, polyethylene-based flexitanks, Polypropylene plastic pallets, HDPE IBCs, HDPE drums, Epoxy-lined or polyethylene-lined steel drums, heat-treated wood pallets? If our packaging material has no intended release and most of them made from polymers, do we still need to proceed to check for SVHC (CMR, PBT), etc? If so, how do we establish SVHC <1MT/yr < 0.1%w/w and what needs to be done thereafter?
- Choong, August 15, 2008
A.Packaging is an article under REACH, the following applies:

Article 7: Registration and notification of substances in articles

… Application 1b: Any producer or importer of articles shall submit a registration to the Agency - if

(a) the substance is present … in quantities totalling over one ton per producer or importer per year

(b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.

More than likely, no substance is intended to be released from your packaging products and no registration applies to you.

If your packaging products contain substances of very high concern a notification may apply.

…Application2. Any producer or importer of articles shall notify the Agency, …, if a substance meets the criteria in Article 57* …, if both the following conditions are met:

(a) the substance is present in those articles in quantities totalling over one ton per producer or importer per year

(b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).

* SUBSTANCES SUBJECT TO AUTHORIZATION

The notification obligations are given in the REACH Regulation TITLE XI, Article 113:

(a) the identity(ies) of the manufacturer(s), producer(s) of articles or importer(s) responsible for placing the substance(s)on the market as specified in Section 1 of Annex VI

(b) the identity of the substance(s) as specified in Sections 2.1 to 2.3.4 of Annex VI

(c) the hazard classification of the substance(s), resulting from the application of Articles 4 and 6 of Directive 67/548/EEC

(d) the hazard label for the substance(s), resulting from the application of Article 23(c) to (f), of Directive 67/548/EEC

(e) specific concentration limits, where applicable, resulting from the application of Article 4(4) of Directive 67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC

For detailed information, read the Guidance for Articles as published in May and available on the ECHA Web site.

Q.Are The food colors i.e. tartrazin and brilliant blue, that are exempt for obligations?
- Hadi, August 15, 2008
A.If the colors are used in foods, they are exempt as food and exempt from REACH. If they have CI numbers and are used in cosmetics, they have to be registered.
Q.Our soap products are generally a reaction mass of fatty acids salts. They do contain additives such as salt and glycerin (these are not chemically changed from its original form upon addition during processing). Do we need to pre-register salt and glycerin or should our salt and glycerin suppliers (non EU) pre-register and we quote their pre-registration number instead? Likewise, as a non-EU manufacturer we sell our products to EU (REACH registration by our registered company in EU) as well as other countries worldwide. These non-EU customers use our products and convert them into their end products and sell into EU. In this case, should our non-EU customers register for REACH or could they share our REACH registration number?
- Choong, August 15, 2008
A.For salts and glycerin, you are an actor within a supply chain who can become a "downstream user" if your suppliers pre-register. For your soap, you may be the manufacturer with registration obligations besides the importer into the EU. This generally applies if a product within a supply chain has been registered by the manufacturer or anybody else up the supply chain. It does not need to be registered by another actor down the supply chain. So if your supplier confirms the pre-registration of the substances purchased by you and provides you with the pre-registration numbers, you do not need to pre-register these substances yourself. Similarly, your customers do not need to pre-register the quantities of substances that they buy from you, as you say you pre-register the substances in your products and provide the pre-registration numbers for all components including those that have been pre-registered by an actor up the supply chain. To summarize, you can ‘share’ the pre-registration numbers for a substance within supply chain.
Q.My company is a producer of polymers in the United States. We will be importing into the EU for our customers for use as raw materials in cosmetics. If the monomers used to make the polymer are listed under EINECS already can we import the polymer until the first deadlines are imposed and require safety testing? What are those deadlines and import levels and when do they kick in?
- Mel, August 15, 2008
A.If your monomers are in EINECS, that means they are phase-in substances in REACH terms. You have to pre-register those in order to benefit from extended registration deadlines. Pre-registration ends on December 1, 2008.
Q.We produce of cosmetics, personal care and surfactants including detergents out of Europe. What are our obligations and responsibilities regarding REACH or what will be the impact of this regulation on our business? What is the result of study on surfactants and detergents up to now, and is there any list to show the present situation of these type of materials?
- Drs.A.Araghi, August 15, 2008
A.Your importer into the EU has to assure the registration of the substances in your consumer goods. If your ingredients’ substances are not registered or pre-registered, you are not allowed to market these within the EU. The registration applies to quantities of substances per importer or manufacturer in the EU. That means you cannot refer to any "existing list."
Q.Our company sells cosmetic ingredients that we private label and purchase from an EU Manufacturer. Will we need to register these products being marketed under our private tradename also. If so are we are classified as a downstream user?
- CAC, August 15, 2008
A.If you buy these ingredients from an EU manufacturer, they have to be pre-registered or registered. Get the confirmation from your supplier, including the pre-registration numbers. You do not need to register substances that have been registered by an actor up the supply chain. You will be under REACH terms a re-importer, the role of a downstream user applies only to EU companies.
Q.MSM, CAS#67-71-0, EINECS#200-665-9 is used primarily for food or food supplements, but my company uses it in a cosmetic formula which would fall under the REACh regulation. However MSM does occur naturally in milk, coffee, tomatoes, tea, swiss chard, beer, corn, alfalfa and many other fruits and vegetables and is not dangerous. Does this mean it is exempt under Annex V category 8 "Substances occurring in nature other than those listed under paragraph 7, if they are not chemically modified, unless they meet the criteria for classification as dangerous."
- ROD, August 08, 2008
A.Please see the definition of substances occuring in nature in Article 3 of the REACH Regulation:

Substances which occur in nature means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means.

If you are using a substance that was obtained from a natural source and by following above definition for processing, then it is exempt. If your substance was obtained differently, e.g. from chemical synthesis, it is not exempt for the use in cosmetics.

Q.Is it possible to prepare a leave in conditioner which is not in liquid form?
- pari, August 08, 2008
A.This forum is for REACH questions. As such, questions outside the REACH regulatory realm will not be fielded. Sorry for the inconvienence.
Q.I am a student of cosmetics. Can you please give me a new topic in using extracts in hair care?
- Pari, August 08, 2008
A.

This forum is for REACH questions. As such, questions outside the REACH regulatory realm will not be fielded. Sorry for the inconvienence.

Q.What is sea fennel? Can i use this in leave in hair conditioner?
- purva, August 08, 2008
A.This forum is for REACH questions. As such, questions outside the REACH regulatory realm will not be fielded. Sorry for the inconvienence.
Q.Are new reg in place for estheticians doing hair removal and peels in WI
- Murph, August 08, 2008
A.This forum is for REACH questions. As such, questions outside the REACH regulatory realm will not be fielded. Sorry for the inconvienence.
Q.Is packing material REACH exempt?
- Anonymous, July 08, 2008
A.No, packaging is an article under REACH terms; therefore, the provisions for articles apply.
Q.Do you have a searchable database of ingredients used in cosmetics and toiletry formulations?
- Betty Wright, July 08, 2008
A.I do not know specifically what you are looking for. There are several with different foci. Here is the EU INCI list which has recently been added online. http://ec.europa.eu/enterprise/cosmetics/cosing.
Q.We buy corn oils from supermarket and use it to make a cosmetic. Is it exempt since it's a food item?
- Anonymous, July 08, 2008
A.Corn oil is not exempt as it is a food item. If a substance is used in cosmetics, those quantities have to be registered. However, corn oil is exempt in Annex IV: 232-281-2 Corn oil: Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Zea mays, Gramineae).8001-30-7.

As Annex IV and V are under revision, please check on the revised publications when available. For now, I have a draft copy of these and that includes corn oil in Annex V.

Draft new Annex V(9): The following substances extracted from natural sources, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC with the exception of those only classified as flammable [R10], as a skin irritant [R38] or as an eye irritant [R36]:

Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts.

Q.My company represents a number of non-EU manufacturers of polymers, polymer preparations and chemicals, as agents on commission basis. Should we pre-register their products as "only representative", "importer" or as "third party representative"? Are there important differences in terms of liability?
- Anonymous, July 08, 2008
A.If you are located in the EU and you are the importer, then you are responsible for all obligations within REACH as the importer. Your suppliers, the non-EU manufacturers, can appoint an only representative and that would make you to a downstream user (with only limited obligations). As the importer, you can appoint a third party representative to handle the activities in the SIEFs. The only representative is fully responsible for all obligations, whereas while appointing a third party representativ,e you as the importer are still fully responsible for the obligations.
Q.Muscovite mica, uncoated, naturally occuring--is it exempt from REACH?
- Anonymous, July 08, 2008
A.Yes, according to Annex V: EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b)

Annex V (7). The following substances which occur in nature, if they are not chemically modified:

Minerals, ores, ore concentrates, cement clinker, natural gas, liquefied petroleum gas, natural gas condensate, processgases and components thereof, crude oil, coal, coke.

Have in mind that Annex V is under review by the commission. As far as discussed for now, the minerals will remain in Annex V after the revision. However, you will have to wait for the official publication of the new Annex V before making final decisions.

Q.We are exporting polymers to the EU. We do not purchase the polymers from the manufacturer, but from a "reseller". We do not know if the monomers that go into making them have been registered by an actor up the supply chain. (In all likelihood, however, the polymers were manufactured in the US.) One of the polymers, for instance, is polyethylene. Do we assume that the monomer ethylene was not registered? And that we need to go ahead and register?
- Anonymous, July 08, 2008
A.I would recommend asking your supplier for information on the supply chain of the polymers. Your supplier may register the monomers himself or purchase polymers with registered monomers. If your monomers are not registered by an actor up the supply chain, then your importer has to register (pre-register) these for you through an only representative. If you cannot trace down the supply chain, I would also recommend to pre-register the monomers yourself.
Q.The following substances extracted from natural sources, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to directive 67/548/EEC with the exeptiom of those only classified as flammable (R10), as skin irritant (R38) or as an eye irritant (R36):

Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts."

Does this means that the deinking soap, no matter if Na-soap or Ca-soap, is exempted even if we are buying the fatty acid and prepare the soap and not ourselves extracting them from natural sources. I suppose that our suppliers are extracting the fatty acid(s) from either vegetable fats or animal fats which would qualify for the exemption. Or could it mean that only an extracted soap is exempted while if you manufacture it you need to register (seems unlogic but a lot of things in REACH is...)
- NR, July 08, 2008

A.If your product is not classified as dangerous other than R10, R38 or R36, the answer is yes.

If you are buying the fatty acid and prepare the soap without extracting the materials yourselves from natural sources, that is within the supply chain, therefore not changing the exemption criteria.

You have to assure through the information of your supplier that your product is from natural sources.

If the fatty acids are not from a natural source, e.g. derived from an oxidation process of alkyl compounds, then these are not exempt.

If the extraction from natural sources means that the extraction can be only performed with water, see Article 3(39). I will let you know as soon as I got that clarification:

New Annex V: The following substances extracted from natural sources, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to directive 67/548/EEC with the exemption of those only classified as flammable (R10), as skin irritant (R38) or as an eye irritant (R36): Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts."

Article 3(39): Substances which occur in nature - means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means.

Q.We are an EU based company importing Deionisation Resin from outside the EU. The resin is made up of SO3H+ (Hydrogen form sulfonated polystyrene copolymer)and R4N+OH- (Hydroxyl form strong base alkyl quaternary ammonium polystyrene copolymer). It is imported as a finished product to deionise water and is suitable for potable/drinking purposes as works on ion exchange rather than adding chemicals. Would this need to be registered under REACH?
- Simon Finnigan, July 08, 2008
A.I tend to believe that your product is an article, meaning the shape, surface and design is more relevant for the function than the chemical composition. I recommend studying carefully the ECHA Guidance on requirements for substances in articles which was published recently. Figure 3 on page 26 gives criteria for deciding on borderline between substances/preparations in special containers / carrier materials or as integral part of articles. If I answer the indicative questions I get to the result mentioned above.

If it is an article than you would need to check on a potential notification (see also the guidance; probably this does not apply), you do not need to register as there is no substance that is intended to be released.

Q.We are a non-EU manufacturer. Could we allow our importer(s) to pre-register but use an only representative to handle the full registration? Would the only representative be permitted the extended registration deadlines?
- Nick, July 08, 2008
A.I had to get an official back-up to answer your question. Here it is: If you want to benefit from the extended deadlines for registration than your only representative has to pre-register. If pre-registration is done by your importer than this importer is the member of the SIEF. At that stage, only the importer can appoint a representative, in that case a third party representative, with the importer retaining full responsibility for the registration.

So the answer to your question is no, as you cannot appoint an only representative after pre-registration.

An option to appoint an only representative after the end of the pre-registration phase is when you import the phase-in substance for the first time afterwards:

Article 28 (6). Potential registrants who manufacture or import for the first time a phase-in substance in quantities of one tonne or more per year or use for the first time a phase-in substance in the context of production of articles or import for the first time an article containing a phase-in substance that would require registration, after 1 December 2008, shall be entitled to rely on Article 23 provided that they submit the information referred to in paragraph 1 of this Article to the Agency within six months of first manufacturing, importing or using the substance in quantities of one tonne or more per year and no later than 12 months before the relevant deadline in Article 23.

Q.We produce polymers for the wet wipes industry outside the EU. The wipes are exported to the EU by our custumer. The article contains more than one ton/year polymer, but it is not released from the article in any reasonable conditions. What is our obligation under REACH?
- Anonymous, June 20, 2008
A.Wet wipes are depicted in detail in the ECHA Guidance for Articles from May 2008. According to this, the cleaning liquid and the substances contained have to be registered (Article 6). The wipe carrier material; however, requires notification according to Article 7(2) and communication according to Article 33.
Q.We are non-EU producer of rerefined (regenerated) oil out of waste oils such as motor oils, industrial oils, etc. which we collect all over the country. If we want to export re-refined oil to EU countries, what are our obligations according to REACH? It is difficult for me to recognize this case in REACH regulation and how to define re-refined oil as it is not a preparation, a substance or an article.
- Michele, June 20, 2008
A.The first step is to check if the components of your motor oil have been registered or will be pre-registered by an actor up the supply chain, e.g. you purchase them in Europe. If this is not the case with you, then your importer or your only representative has to register/ pre-register the substances in your products.

Lubricants are not my area of expertise; however, I spoke to a person at the lubricant association here, and he told me the following:

It depends on how you refine the oils, e.g. if you just distil or if you hydrogenate. Then check in ESIS for the EINECS number describing your product. If you search for hydrocarbons in ESIS, you get a list with EINECS and CAS numbers. He mentioned you should also check Annex XVII of the REACH regulation. With the appropriate EINECS numbers you will have to pre-register your substances. You will also have to register (pre-register) any additives that are not necessary for the stability of your products (see REACH substance definition).

Q.Is glycerin REACH exempt?
- Wendy, June 20, 2008
A.No, it is not a natural according to Annex IV and V.

Both annexes are under revision and the commission services have prepared a draft proposal for amending Annexes IV and V. The proposal has been submitted to scrutiny by the European Parliament and council pursuant to Article 133(4). It is foreseen that the adoption of this proposal will take place in October or November 2008.

Please pre-register in any case.

Q.We are importing in the EU several pigments consisting in mica coated with titanium dioxide and/or iron oxide at different concentrations. Would you consider this as a preparation or as a multicomponent material? Would you pre-register subatances such as mica, titanium dioxide and iron oxide individually?
- Anonymous, June 20, 2008
A.These are preparations and each substance of the preparation has to be registered when exceeding one ton/year of volume imported.

You should question if Annex V applies. Point 7: The following substances are exempt from Titles II, V & VI, which occur in nature, if they are not chemically modified:minerals, etc.

But have also in mind that Annex V is still under revision. Please see the revised publication before making your final decision.

Q.We are a US beauty company that has a European subsidiary that imports our cosmetic products into the EU. What obligations under REACH does our EU subsidiary have as an importer of preparations? Is is mandatory that our EU subsidiary pre-register substances used in our preparations or may we shift the burden to our manufacturers and raw materials suppliers?
- Anonymous, June 20, 2008
A.The importer (your EU subsidiary) has to assure that the substances on their own or in preparations are registered of get registered. If your suppliers took care of registration within the supply chain you belong to, than you do not need to register these again. Ask your supplier for a confirmation.
Q.Are interference pigments such as mica coated by TiO2 preparations or substances?
- Aina, June 20, 2008
A.These are preparations and each substance of the preparation has to be registered when exceeding one ton/year of volume imported. You should question if Annex V applies. Point 7: The following substances are exempt from Titles II, V and VI, which occur in nature, if they are not chemically modified: minerals, etc. Also have in mind, that Annex V is still under revision. Please see the revised publication before making your final decision.
Q.Article 15: substances regarded as being registered, including biocidal products - Active substances manufactured or imported for use in biocidal products only. Does this exclude biocides from the Registration including all products which use them in non-biocidal applications such as cosmetics?
- Anonymous, June 09, 2008
A.According to the information given during the ECHA workshop in April, this article applies only to products used in plant protection, e.g. pesticides. All quantities used in other applications, e.g. in cosmetics, have to be pre-registered.
Q.I'm a student studying the sustainability of existing cosmetics. I'm looking for information that explains the entire process tree that cosmetics take from creation to disposal. Are there any online references that would help me with this?
- Marie , June 09, 2008
A.My suggestion is to look into the web pages of the following industry associations and to contact these with your needs: CTFA now Personal Care Product Council, Colipa, US Food and Drug Administration and the EU Commission.
Q.As a non-EU manufacturer, we sell substances to non-EU companies who then have subsequent sales to their own customers in the EU. Would these customers of our customers be considered within our supply chain? If so, can we set up an OR that can track volumes for these indirect customers (EU importers)?
- Anonymous, June 09, 2008
A.We are still waiting for further information from the ECHA on important aspects of the only representative, which is still under revision. Without that important information and based on the information you are giving, here my answer:

If these indirect customers are the importers, than those would have to provide all information on importation quantities to the OR and become downstream users.

If the importer is the non-EU company you mention, than the quantities imported by this company would be the information necessary and would be filed by the OR.

Q.What is the registration year/dead line for NLP's?
- Bein Zohar, June 09, 2008
A.NLPs are phase-in substances. If you pre-register these, you benefit from the extended registration deadlines for pre-registered substances.
Q.We export polymers in pellet form to the EU. When we reviewed the initial GUIDANCE FOR MONOMERS AND POLYMERS, we determined that we did not not need to register the polymers since they met the molecular weight definition (2.2) and they did not consist of 2% by weight of monomer(3.2.1.1). However, we became confused about the monomers after reading the revised GUIDANCE FOR MONOMERS AND POLYMERS that issued in March 2008. Are we required to register the monomers that were reacted to make the polymers (example 3)? For example, one of our polymers is polyethylene. It is high molecular weight and has < 2% residual monomer. Do we need to register the ethylene monomer from which it is made?
- Anonymous, June 09, 2008
A.There was no change to the basic requirements between the first guidance document for monomer and polymers and the update; however, it may have been expressed in the update in a clearer way.

Indeed, as the importers of polymer substances or polymers in preparations, you have to assure that all monomers and other chemically bound substances are registered within the following conditions Article 6(3):

-The polymer consists of 2% w/w or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s)

-The total quantity of such monomer substance(s) or other substance(s) makes up one ton or more per year.

-Any unbound additive which does not function as stabilizer has to be registered when manufactured or imported on its own or in a polymer preparation in quantities of at least one ton per year - Article 6.

-It is the ‘monomeric unit’ that has to be considered, meaning the reacted form of a monomer substance in a polymer; ‘other chemically bound substances’ are, e.g., initiators or end groups. It is not only the quantity of residual, unreacted monomers. In your example case, it is the tonnage of ethylene monomer, reacted and unreacted, that has to be registered.

You do not need to register the monomer substance or any other substance chemically bound to the polymer if these have already been registered by the supplier or another actor up their supply chain.

Q.Can an only representative appoint any other European legal entity as third party representative?
- Anonymous, June 09, 2008
A.This is an area where I myself am searching for answers to several questions at the moment. I am waiting for the ECHA’s "Interpretation of an important aspect of the 'only representative' according to Article 8 of the REACH Regulation," which is currently under revision. I will further advise as soon as this information will be available.
Q.First of all, I am appriciating your detailed answers that you got back to me before. I have another suspicion about white goods or other articles for example household appliances or TVs are always sold in the form of rolled by nylons and then packed in a carton. I know articles obligations under REACH. In this case articles always are sold with their packaging materials(rolling nylons and then packaging materials)so do I have REACH obligations of these two materials also? After being used the articles these packaging/rolling materials are generally disposed of. My question is in this case above does it make dífference about the obligations (notification obligations of packaging materilas)of this kind of packaging materials of articles under REACH when the articles are submitted to EU market in rolling/packaging materials though?
- Ozlem, May 19, 2008
A.If I understand you correctly, your question is: Do I have to consider the nylons and cartons used for packaging within REACH?

Packaging materials are articles under REACH, so the same obligations apply to the packaging materials as do for the articles itself which are packaged (appliances, TVs, etc.).

Q.Preparation manufacturers in non-EU countries exporting their prerapations to EU have to make sure that all the substances they have in their preparations are pre-registered for now. Companies should be in touch with the suppliers about that. However, do you think it is best to pre-register the substances supplied from other non-EU countries in case they do not. And what do you think about the substances a non-EU manufacturer supplies from an EU manufacturer? Will the tonnages sold to non-EU countries also be definitely pre-registered by the EU country? How can we be sure about that?
- Dr.Yaprak Yüzak Küçükvar, May 19, 2008
A.I observe first approaches by manufacturers of preparations here in Europe and abroad to get assurance from their suppliers that they pre-register and register. It is usually a standard letter requesting that information per product. I do recommend to request this information from your suppliers, and to also that they provide the pre-registration number, which will be issued by the ECHA upon pre-registration (info from the REACH-IT workshop – April 14 in Brussels), as soon as possible. If your supplier does not agree to pre-registration and registration, you will have to make a decision, as the substances that you import into the European Union have to be registered after June 1, 2008 (pre-registered in order to benefit from the extended registration deadline).

It is the manufacturer in the EU who is responsible for all obligations within REACH for the substances he manufactures. To be reconfirmed, you may also request the information as described above from the EU manufacturer.

Q.Could you please provide information can I change "only representative" and under which conditions
- Ksenia, May 19, 2008
A.The interpretation of an important aspect of the only representative according to Article 8 of the REACH regulation is currently under revision by the commission. For final answers we will have to wait for the publication of that review.

What at the moment accounts is, that the only representative can be changed. The change results in a new registration, according to the information provided at the REACH-IT Workshop in Brussels on Feb. 14, 2008.

Q.We are a Non EU manufacturer of fragrance products who import into the EU. What are our obligations under reach? Are we considered "downstream users"? Assuming our upsteam suppliers are registering chemicals we use in our processes, are we required to register chemicals used in our products? REACH does require packaging/labeling requirements for finished products, correct? Can you provide timelines for when these go in effect?
- Anonymous, May 19, 2008
A. You have to assure that the substances (the aroma chemicals) in your fragrance formulations comply with the REACH regulation.

You are not considered downstream users because you are not established in the European Union. Your importer or your Only Representative in the EU is responsible for the registration of your ingredients.

You are not required to register chemicals used in your products as substances which have been registered in accordance with Title II and which are re-imported or recovered in the community are exempt from Title II (Article 2).

Packaging and labeling requirements for finished products are formulated in other EU regulatory frameworks, for fragrances applies most importantly to the Cosmetics Directive, also the Pre-packaging Directive and the Directive on Packaging and Packaging Waste. REACH applies to packaging materials, as these are articles under REACH, in the following way:

Registration and notification of substances in articles. Any producer or importer of articles shall submit a registration to the Agency if: (a) the substance is present … in quantities totalling over one tonne per producer or importer per year. (b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.

If a substance is subject to authorization than any producer or importer of articles shall notify the Agency if both the following conditions are met:

(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year (b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).

Q.Regarding market presence before June 2007, is the presence based on a sale or can substance sampling be considered?
- Anonymous, May 19, 2008
A.The date of June 1, 2007, marks the date of entering into force of the REACH legislation. The date has no direct importance when it comes to market presence of products. Generally the quantity thresholds within REACH relate to substance manufactured in the EU or imported into the EU.
Q.Suppose an o/w emulsion, shows signs both of creaming and some coalescence of oil droplets. Based on factors that we can control and priciles of stabilization by surfactants or other additives, what are the few ways we can try to modify the composition and processing of this emulsion to improve stability.
- Anonymous, May 19, 2008
A.This is a REACH forum; as such I cannot answer technical questions here.
Q.If our customer used our material in their formulation, can this be considered for a pre-existing market presence?
- Anonymous, May 19, 2008
A.Pre-existing market presence is not a term within REACH, you are probably talking of phase-in substances. Phase-in substances have to comply with the following definition

(a) They are listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) – so called existing chemicals

(b) It was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this.

(c) It was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, before entry into force of this regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this regulation, provided the manufacturer or importer has documentary evidence of this –so called no-longer-polymers.

Q.If our material had an acceptable market presence, but did not have a CAS number. If we now apply for a CAS number, will it be considered a grandfathered market presence or a new substance?
- Anonymous, May 19, 2008
A.The REACH term for grandfathered market presence is phase-in substance. The CAS-number is not the most important identification for a phase-in substance, here are the definitions:

(a) they are listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) – so called existing chemicals.

(b) It was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this.

(c) It was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this –so called no-longer-polymers.

These phase-in substances can be pre-registered and thus benefit from an extended registration schedule. If above does not apply to your substance and the manufacturing or import quantity exceeds one ton, than you have to register directly with the European Chemicals Agency as of June 1, 2008.

Q.It is my understanding that materials that had a market presence before June 2007 can be considered as a phase-in substance for pre-registration. Is there a low date i.e., 1981 limit for this presence?
- John Carratura, May 19, 2008
A.Phase-in substances are defined in the following way, and not generally, according to market entrance date:

(a) they are listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) – so called existing chemicals (1981 (Sept.18) marks the final date for an entry into EINECS)

(b) it was manufactured in the community, or in the countries acceding to the European Union on Jan. 1, 1995 or on May 1, 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this

(c) It was placed on the market in the Community, or in the countries acceding to the European Union on Jan. 1, 1995 or on May 1, 2004, before entry into force of this regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this regulation, provided the manufacturer or importer has documentary evidence of this so-called no-longer-polymers.

Q.Materials with ELINCS numbers are exempt. Does this apply to all tonnage bands?
- John Carratura, May 19, 2008
A.Article 24/REACH -Notification in accordance with Directive 67/548/EEC-says:

"If the quantity of a notified substance manufactured or imported per manufacturer or importer reaches the next tonnage threshold under Article 12, the additional required information corresponding to that tonnage threshold, as well as to all the lower tonnage thresholds, shall be submitted in accordance with Articles 10 and 12, unless it has already been submitted in accordance with those articles."

In other words, the requirements for notifications according to the directive on Dangerous Substances were based on tonnage thresholds and so are those for REACH. Whenever you are exceeding the threshold you have submitted the necessary information for, you have to fulfill and comply with the higher information demands for the higher tonnage band.

Q.1. Do PVC exports need to be registered?

2. Molded furniture is made-up of polymers. But do the monomers of those polymers need to be registered?

3. Do the plastic components need to be registered by the automobile manufacturer?

4. If the substance is already registered within higher tonnage band and if some exporter is exporting the same substance within lower tonnage band with extended registration deadline so what will be the procedure for registration of the same substance with lower tonnage band?

5. Food container contains polyurethane foam for the insulation purpose; do those also need to be registered within REACH?
- Anonymous, May 19, 2008

A.1. PVC, as a substance or in preparations, within the definition of REACH for polymers is as polymer exempt. However, if your monomers are not registered by an actor up the supply chain, these have to be registered.

2. Molded furniture is an article under REACH. Here the obligations for articles apply – see Article 7/REACH Regulation:

Registration and notification of substances in articles

Any producer or importer of articles shall submit a registration to the Agency if (a) the substance is present … in quantities totalling over one ton per producer or importer per year (b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.

If a substance is subject to authorization than any producer or importer of articles shall notify the agency if both the following conditions are met: (a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year (b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).

Most likely no obligations under REACH result for you when importing the furniture into the EU.

3. The same applies here as said above under 2.

4. A registration applies to the manufacturer or importer of a substance. If the importer of the lower tonnage band is a different importer than that one of the higher tonnage band, than this importer of the lower tonnage band needs to register the substance and fulfil the registration requirements requested for the respective tonnage band. As this importer has pre-registered, according to your scenario, he will most likely join a SIEF and file a joint registration with the other participants of the SIEF.

5. Packaging (as such containers) is also an article under REACH, the same applies as described under 2 above.

Q.As a manufacturer just starting to export to the EU, what are my concerns about REACH for this year?
- Dan Bosmann, May 07, 2008
A.You have to analyze your product portfolio for phase-in substances imported to the EU in quantities of 1 ton or more per year. These have to be pre-registered as of June 1st. Your importer is responsible for pre-registration and registration; however, you may appoint an only representative to fulfil these obligations.

All substances have to be either pre-registered between June 1st & Nov. 30th or registered with the European Chemicals Agency after June 1st. If not, it is illegal to trade these substances in the European Union or to use these substances meaning your customers are not able to use these.

Q.We produce an acrylic emulsion for a nonwoven company outside the EU which sells it products to the EU. To our understanding, substances in articles must be registered if three conditions are met (according to ECHA FAQ VER.2.1 chapter 8). Our emulsion is not intended to be released in any normal and reasonable and forseeable conditions.The other two conditions are met,but according to the ECHA guidance for monomers and polymers, a polymer must be registered if two conditions are met: the polymer contains more than 2%w/w of chemically bound monomers and the total amount of monomers in the polymer exeeds 1 ton per year. (these conditions are met regarding this client of nonwoven) Do we have to register the monomers in the polymer? (regarding this application) THANK YOU VERY MUCH
- Anonymous, May 07, 2008
A.You have to explain in more detail what it is that is imported into the EU. Is it a nonwoven core that is surface treated with an acrylic emulsion later hardens and results in a plastic article with a nonwoven core? Then all obligations for articles under REACH would apply, because an object was manufactured where special attention is given to shape, surface or design during production that determines its function.

Any producer or importer of articles shall submit a registration to the Agency if:

(a) the substance is present in quantities totalling over one ton per producer or importer per year

(b) the substance is intended to be released under normal or reasonably foreseeable conditions of use

If a substance is subject to authorization, then the producer or importer of articles shall notify the agency if both the following conditions are met:

(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year

(b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).

If it is something different, please explain.

The obligations for monomers under REACH apply to polymer substances and polymers in preparations, not to articles made with polymers.

Q.I represent a company that blends substances to produce finished products and am a downstream user; however, we do a couple of fatty acid neutralizations. Can you please confirm that we are classified as a 'manufacturer' and therefore will need to pre-register the 'soap formed' ourselves? Many thanks
- Mike, May 07, 2008
A.Please be careful about defining your role within REACH. If you blend substances to a product and you are located outside the European Union, you most likely have responsibilities for REACH, as your starting materials most likely are not registered by an actor up the supply chain. When importing into the EU, these substances have to be registered.

Your neutralization products have to be registered, in case of phase-in chemicals pre-registered. If you are located outside the EU, the importer has this obligation. However, you may decide to appoint an only representative to fulfill the obligations.

If you are located inside the EU, for the blends you would indeed be a downstream user, and a manufacturer for the soaps. Manufacturers in the EU are responsible for the registration whereas downstream users have to communicate about their use of substances.

Q.where can someone learn the art of fragrance and raw cometic formulars
- Anonymous, April 28, 2008
A.There are many schools that come into my mind such as Fairleigh Dickinson University in the United States. However, this is a REACH forum, and the focus here is on REACH.
Q.Dear Madam, I want to know is it compulsary to enter the read across (similar Substances) information in Pre-registration dossier for any substance. and how should i get the information on the read across substances. kindly help in this matter?
- Shree, April 28, 2008
A.The pre-registration requires an identification of the substance by EC number, CAS, etc. You may give further information (read across), however, read-across is also still possible after the end of pre-registration.

Reading across is always based on an expert judgment. Further information you will find in various Guidance Documents:

•Guidance on pre-registration and data sharing

•Guidance on registration

•Guidance on evaluation, etc.

A guidance on information requirements under REACH is not yet availble, but is being prepared.

Q.REACH requires each "legal entity" to register seperately. Does that mean that every single company that uses or imports a particular substance has to register?
- Sarah, April 28, 2008
A.This was one of the issues discussed during the REACH information day of the ECHA in Brussels last Monday. My understanding from this meeting and from the Guidance Document on Pre-registration and Data Sharing’ is, yes, every legal entity of a parent company in Europe has to register the substances they manufacture or import. However, you can assign a third party representative who can handle all administrative and SIEF issues for all different entities together. However, a separate pre-registration and registration is required (in IUCLID 5, REACH-it or Pre-Reg plug-in) and the legal entities retain the full legal responsibility for complying with the obligations under REACH.
Q.I work for a non-EU company. The company produces food packaging materials made up of paper and ink on it. We do have REACH obligations. It is clear that packaging materials are exempt from registration, but I am not sure if this packaging materials are exempt from notification obligation even known potential high concerned chemicals tested before for food regulation. According to Article 7(2)caltulated content result is under % 0.1 w/w of each chemcials in packaging materials. In this case, is it possible to say that the packaging material is out of `'notification'' obligation under REACH? Would you please informed me issue?
- Ozlem Tiryaki, April 18, 2008
A.Packaging materials are articles under REACH as objects that during production is take a special shape, surface or design which determines its function. Therefore the following applies:

Registration and notification of substances in articles > Any producer or importer of articles shall submit a registration to the Agency if (a) the substance is present … in quantities totalling over one tonne per producer or importer per year; (b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.

If a substance is subject to authorization than any producer or importer of articles shall notify the Agency if both the following conditions are met: (a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year; (b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).

As for the packaging itself, there is usually no substance that is intended to be released. No registration is required for packaging.

If your containers contain a hazardous substance, e.g. as part of the ink or additives, etc., then a notification is requested above those concentration limits given above. If the substance is present in the packaging under %0.1 w/w as you say, than this is not the case and you do not need to submit a notification.

Q.As I understand it, aqueous extracts of natural material are exempt. However, they will usually be supplied with additives such as preservatives, anti-oxidants and/or carriers, that is as a mixture. What registration and/or pre-registration is required for the mixture?
- Barry, April 18, 2008
A.The definition of a substance is:

…a substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

Do you think that this applies to your additives?

This can be extended by Annex V:

…registration is deemed inappropriate or unnecessary

• Point 1 & 2: Substances which result from a chemical reaction that occurs incidental to exposure or storage of another substance, preparation or article…. • Point 4: Substances which are not themselves manufactured, imported or placed on the market and which result from a chemical reaction that occurs when: a stabiliser, colorant, flavouring agent, antioxidant, filler…. functions as intended.

That means, even if a modification on the naturals happens incidentally from the additives, no registration requirements result.

Q.What is the controversy within the ECHA regarding "new/non-phase in" cosmetic ingredients? I've heard some rumblings that these substances may be exempt? Any insight?
- AAC, April 18, 2008
A.Exempt from registration? No, and I doubt it. But I am attending a meeting next Monday and will further research. Any more detailed information from your side would be appreciated.
Q.Under annex IV, EC # 200-312-9 palmitic acid ,pure EC# 200-313-4, stearic acid, pure EC#204-007-1 oleic acid, pure EC# 205-582-1 lauric acid, pure EC#266-925-9 fatty acid, C12-18, etc. are exempted from from obligation to register. 1. What constitutes "pure." 2. Is there any differentiation based on the process route or the source of raw material used? 3 Are palm and palm kernel dervied fatty acids included in this calssification? If not please elaborate. TKS
- CHUAN, April 18, 2008
A.1. I will discuss this in an expert meeting, that I will attend next week and get back to you afterwards. Have in mind, the actual entries in Annex IV are also still under review.

2. There are strict requirement for the extraction of naturals when exempt according to Annex V. Please read my REACH Update March 2008: Specifics for Natural Ingredients. However, exemption according to Annex V is no longer applicable for modified naturals, such as fatty acids.

3. We will have to wait for the publication of the reviewed Annex IV for final answers and decisions.

Q.A substance has 2 components, major component A> 90% and minor component B <10%. 1. Are we correct that only component considered pure (>80% rule )needs to be pre registered? 2. If aggregate of the minor component imported into EU does not exceed 1 mt, do we need to register the minor component as well?
- CHUAN, April 10, 2008
A.The definition of a substance according to REACH is the following: "Substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition."

Consequently if your product consists of two components, your product is a preparation (a mixture or solution composed of two or more substances) and every component needs to be registered with the threshold limit is 1 ton per year. Substances manufactured or imported in the EU below this value do not need to be registered.

Q.1. We need your advice on the actions to be taken after we have pre-registered a substance. Should we wait for the formation of SIEF if eco toxicology data is not available to our knowledge. 2. Can published data,eg in IUCLID be quoted during registration stage OR need fresh data from OECD approved laboratory? 3. How does the info sharing and cost sharing under SIEF operates? TKS
- CHUAN, April 10, 2008
A.1. Definitely yes, as the major goal of SIEFs is avoiding the duplication of studies.

2. The regulation clearly states, "Before new tests are carried out .. all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first."

3. All information available at this point is summarized in my articles in C&T Today titled SIEFs and Consortia and Preparation for Pre-registration and SIEF Formation – Part 1. To read these newsletters, visit p> Further developments here in Europe on this, especially consortia formation, will be also published there.

Q.1. Can the substance name -Fatty acids,C8-C18 & C18 unsaturated,sodium salt, EINEC No 266-934-8, CAS No 67701-10-4 be used to describe soap noodles derived from the neutralization of fatty acids, palm oil? If not, please elaborate. 2. Why are there different CAS & EC # for palm dervied fatty acid. The chemical property of a pure substance should be independant for the source of raw materail? 3. We understand that the above EC # is only to be used for fatty acids containing odd chains component. Are we correct? TKS
- CHUAN, April 10, 2008
A.1. For substance identification, so-called main identifiers are defined. For your substance, the main identifiers would be "plant source, production process" and others. Please see "GUIDANCE FOR SUBSTANCE IDENTIFICATION AND NAMING IN REACH" as published on the ECHA website on this. Once you named your main identifiers, you can assign the EINECS number. For this you can use the European Chemical Substances Information System (ESIS).

2. For EC numbers, I do not think that this is the case if you follow the main identifier path. For CAS numbers, it may be the case because in the CAS registry process sometimes various numbers for a substance exist. In case of palm oil derived fatty acids, you are looking at so-called UVCBs: Substances of Unknown or Variable composition, complex reaction products or biological materials.

3.The definition of that substance is: EC# 266-934-8 > C8-C18 and C18 unsaturated alkyl carboxylic acid sodium salt. This EC number may be assigned to any fatty acid sodium salt mixture with that chain distribution.

Q.I would like to ask you another question related to the Only Representative issue. As you well know the Only Representative Companies are taking many liabilities towards ECHA, towards the manufacturer, at the etc. Do you believe there are insurance companies who would cover a company with that many liabilities in EU? What are your comments on that?
- Yaprak Yüzak Küçükvar, April 10, 2008
A.It is very difficult at this moment to estimate the risks and potential liabilities. All of us involved in REACH know that this is a new exercise with many unknown aspects. Personally, I approach REACH with the highest professional standards and ethics. I also am cooperating with professional networks and industry associations. There I find great support and believe that this is the best insurance for me and my clients.
Q.We are a chemical producer outside the EU. However we are considering our sister company in the EU to be our legal entitiy. Q1. What are the requirement of the sister company before the company can act as our legal entity Q2.REACH is rather complex. We are thinking of engaging a consultant to guide us through the process of pre registration,registration and CSR and other data prparation. Where can we get this service
- Anonymous, April 03, 2008
A.

Q1. What are the requirements of the sister company before the company can act as our legal entity?
For REACH purposes it has to be a legal entity established within the EU that is either manufacturing or importing a substance (see Guidance on Registration). A non-EU company may also appoint a natural or legal person established in the Community to fulfil, as only representative, the obligations on importers under REACH.

Q2.REACH is rather complex. We are thinking of engaging a consultant to guide us through the process of pre-registration, registration and CSR and other data prparation. Where can we get this service?
Please contact me at annelie.struessmann@conusbat.com.  

Q.We are a producer of soap noodles via fatty acids dervied from palm oil and palm kernel oil outside the EU. Q1. Does soap noodles require registration under REACH? If YES, Q2 soap noodles can be described as"C8 -18, C18 unsaturted fatty acids, sodium salt " or as a "mixture of palm oil fatty acid, sodium salt and palm kernel oil fatty acid, sodium salt" how do we select the CAS and EINECS numbers when choices are available?? Q3.If the soap noodles has an additional potassium salt, above what proportion do we consider the potassium salt as a component? Q4. Do we need to delare the minor additives ,chealnts that are in ppm level??
- Anonymous, April 03, 2008
A.

Q1. Does soap noodles require registration under REACH?
Soap based on palm or palm kernel oil is a substance occurring in nature that has been chemically modified. As such, it falls under REACH.

If YES,
Q2 soap noodles can be described as"C8 -18, C18 unsaturted fatty acids, sodium salt " or as a "mixture of palm oil fatty acid, sodium salt and palm kernel oil fatty acid, sodium salt" how do we select the CAS and EINECS numbers when choices are available?
EC#263-097-0 CAS#61789-89-7 Substance name: Fatty acids, palm kernel-oil, sodium salts
EC#263-162-3 CAS#61790-79-2 Substance Name Fatty acids, palm-oil, sodium salts
Source: ESIS - http://ecb.jrc.it/esis/index.php?PGM=ein

Q3.If the soap noodles has an additional potassium salt, above what proportion do we consider the potassium salt as a component? Any substance above 1 ton per year (import into the EU) has to be registered. If the potassium salt exceeds that limit, it has to be registered.

Q4. Do we need to declare the minor additives,chealants that are in ppm level?
Have in mind the definition of a substance: a substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. If your additive is falling under the underlined above, it does not need to be registered. If not and if the total import volume is exceeding one ton per year, it needs to be registered. When added at ppm level, that is most likely not the case.

Q.the difference between 'legal entity', 'only representative' and 'third party representative' and their roles in the registration and preregistration processes.
- Aditi, April 01, 2008
A.

A third party representative can be appointed by manufacturers, importers or downstream users located in the EU and is involved in all joint steps for submission of data, data sharing and cost sharing, whereas the appointer retains full responsibility for complying with his obligations under REACH. The identity of the appointer shall not normally be disclosed by the agency.

The only representative can be appointed by non-community manufacturers, and the obligations include all those of an importer under REACH. The only representative is legally responsible for registration under REACH. It has to be a natural or legal person established in the community with sufficient background in the practical handling of substances and the related information.

Generally, a legal entity is an individual or organization that is legally permitted to enter into a contract. In the case of REACH, it can be a manufacturer, an importer, a subsidiary of a company or an only representative. It is important to identify the legal entities that can pre-register or generally can perform the steps under REACH, these are only legal entities established in the EU.

Q.Dear Madam Strussman, I am writing you on behalf of an American manufacturer of chemical products with its European office based in the Netherlands. We were wondering where we could find a list of certified only representatives for the REACH implementation. Thank you
- Raluca Ciochina, March 27, 2008
A.

A certification for a representative or  an only representative (OR) does not exist and, therefore, there is no list. Similar to choosing a physician or lawyer, you have to evaluate the people that offer the services and find the best match for your needs.

The REACH Regulation states requirements for an only representative in Title II, Chapter 1, Article 8(2). To this end, the OR shall have a sufficient background in the practical handling of substances and the information related to them. The REACH Regulation does not elaborate on this, although the Cosmetics Directive (76/768/EEC) does require that the safe assessor must hold a diploma as defined in Article 1 of Directive 89/48/EEC.

I am representing American companies as an OR based on a degree in chemistry and 20 years of industry experience in technical and regulatory affairs. For further transparency to potential clients, I am providing e-trainings, this REACH Roundtable and a monthly newsletter with C&T.

You will have to specify your company’s requirements for compliance with REACH and base your decision on these. As I am residing in the Netherlands, I would be glad to meet and further discuss this with your European company representatives.

Q.Dear Sir, I am a non EU Manufacturer of chemicals and exporting to EU. I am exporting the chemicals to EU for which I need to do pre-registration and registration. I am supplying these chemicals in the plastc containers which are painted in differnt colors. i want to know what will happen to those container? Do i need to register for those containers also? Kindly Suggest
- Shree, March 27, 2008
A.

Packaging materials, be it drums, foils, cartons, etc., are articles under REACH, as they are objects that give a special shape, surface or design to a product during production that determines its function. Therefore the following applies:

Registration and Notification of Substances in Articles
Any producer or importer of articles shall submit a registration to the agency if:
(a) the substance is present in quantities totalling over one ton per producer or importer per year
(b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.

If a substance is subject to authorization, than any producer or importer of articles shall notify the agency if both the following conditions are met:
(a) the substance is present in those articles in quantities totalling over one ton per producer or importer per year;
(b) the substance is present in those articles above a concentration of 0.1% weight by weight (w/w).

Where there is no substance in packaging that is intended to be released, no registration is required. If your containers contain a hazardous substance, e.g. as part of the paint or the polymer additives, etc., than a notification is requested above those concentration limits given above.

Q.I WOULD LIKE TO KNOW THE METHOD FOR THE QUANTIFICATION OF UVA AND UVB IN OUR COUNTRY. MY COUNTRY IS SRI LANKA IS IN INDIAN OCEAN
- PAMODYA SIRIWARDANA, March 27, 2008
A.This is a REACH forum. REACH is the new regulatory framework for chemicals in Europe and stands for Registration, Evaluation, Authorization & Restriction of Chemicals. While I am also an expert for cosmetics regulation my specialty lies in Europe and not for your country. I am very sorry.
Q.I am a supplier of natural ingredients & botanical extracts used as an ingredient in manufacture of skin & hair care products. Do I have to pre register or register these ingredients?
- Jay, March 27, 2008
A.

Natural substances are defined in Article 3(39):

The reference to substances which occur in nature is referring to naturally occurring substances that are unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means.

These natural substances are exempt from registration acc. to Annex V(8) if they are not chemically modified, and if they meet the criteria for classification as dangerous according to Directive 67/548/EEC.

That means:
-Aqueous extracts are exempt
-Pressed oils are exempt 
-Extracts with solvents other than water need to be registered / threshold 1 tonne / year

Have in mind, that solvents, preservatives and other additives fall under REACH and need to be registered above the threshold value (1 t/y).

Also fyi, the Annex V is still under revision by the European Commission and ECHA. All naturals have to be reconsidered with the publication of that review before pre-registration.

Q.We are a non-EU company exporting polymers to the EU. Some of the polymers have additives blended with them ranging from 0.1% to 1.5%. Do we need to register the additives if the total amount of each additive is less than one tonne per year?
- Anonymous, March 27, 2008
A.

If you are importing polymer substances or polymers in preparations into the EU, the threshold is one ton per year for additives that do not function as stabilizers.

Have also in mind, that all monomers and other chemically bound substances have to be registered within the following conditions per Article 6(3):

- The polymer consists of 2% weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units* and chemically bound substance(s)

- The total quantity of such monomer substance(s) or other substance(s) makes up one tonne or more per year.

*A ‘monomeric unit’ means the reacted form of a monomer substance in a polymer, ‘other chemically bound substances’ are, e.g., initiators or end groups.

As you are located outside the EU, your monomers may not be registered by a manufacturer up the supply chain.

Q.An Only Representative has a duty to keep a record of all imports into the EU for the substance in question from a specific non-EU manufacturer. Can the Only Representative refuse to allow an importer to use their OR status to claim downstream user status? If not how can the OR ensure that imports stay below the tonnage threshold and if yes is this not a restraint of trade and anti-competitive under EU Laws (on what basis do they refuse)? Finally if the substance is sold by the non-EU manufacturer to an overseas trader and then is imported into the EU using their OR status can this be done without their knowledge of the tonnages involved? (There does not appear to be a duty for the importer to report tonnages to the OR)
- Andrew, March 19, 2008
A.

Can the only representative refuse to allow an importer to use their OR status to claim downstream user status?

It is not the only representative but the non-EU manufacturer who decides to register substances through an only representative:

Article 8 (3). If a representative is appointed in accordance with paragraphs 1 and 2, the non-community manufacturer shall inform the importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this regulation.

If not, how can the OR ensure that imports stay below the tonnage threshold. If an importer registers the same substance as another supplier, than the importer has to register only those quantities. On the other hand, the importer informs the only representative only about those quantities that he obtained from the manufacturer that appointed the only representative. This may be a restraint of trade and anti-competitive under EU Laws. It is the manufacturer who decides on how to protect his interests.

If the substance is sold by the non-EU manufacturer to an overseas trader and is imported into the EU using their OR status, can this be done without their knowledge of the tonnages involved? You will need the cooperation of the non-EU manufacturer in order to be able to comply with REACH.

Q.Dear Ms./Mrs.Struessman, I would like to introduce myself as a member of REACH Department in İstanbul Chemicals and Chemical Products Exporters’ Association. I am doing a research on the Confidential Only Representative Companies which can help our members(manufacturers)for compliance of REACH. As you may well know, there are a number of Only Representative Companies in the EU at the moment. As we all know there is no organisation to accredit these companies and ORs in the EU. What do you advice as a professional to non-EU companies while they are doing a choice for an Only Representative Company. What are the most important technical details that should be pointed out during the meetings and agreements with the Only Representative? Thanks in advance for your time and help. Best Regards, Dr.Yaprak Yüzak Küçükvar
- Dr.Yaprak Yüzak Küçükvar, March 19, 2008
A.

Thank you for an interesting question. My answer is based on my experience of being an only representative myself.

REACH is a very complex regulatory framework because it requires a large amount of regulatory knowledge, and there are many areas where new approaches were taken and open questions towards the practicality exist. To be able to fullfill the requirements, an only representative needs to have at the minimum the following background:
• A profound knowledge of the regulatory framework in its complete complexity
• An intense understanding of the chemistry and application of substances in the focus of REACH
• Familiarity with EU regulatory affairs and compliance approaches

If representing non-EU companies, work experience in an international environment is needed in order to understand the different attitudes and approaches towards legal questions and to understand and cooperate efficiently with the manufacturer and the European customers or importers. I recommend cooperation on a ‘natural person’s’ level, as there is a lot of confidential interaction with the manufacturer.

Last not least, I find it extremely important for the representative to have a European network of regulatory and industry professionals, and to be connected to European industry associations and authorities. I hope that I was able to provide you with some interesting aspects.

Q.I want to know which dictionary has the CAS of the cosmetic ingredients.
- Yali Shi, March 19, 2008
A.This question is not exclusively directed towards REACH, so I hope I am understanding you correctly. If you are generally looking for CAS numbers of cosmetic ingredients, I am using and recommending the EU Web site on INCI, http://ec.europa.eu/enterprise/cosmetics/inci/inci_2006.pdf, or the Index on Cosmetic Ingredients by chemical name: http://ec.europa.eu/enterprise/cosmetics/inci/incichk.htm.
Q.The following answer is a follow up to a question on 3/2/2008 by Ozlem.
- Ozlem, March 19, 2008
A.

Dear Ozlem,

 As promised, after discussion with REACH officials, I am getting back to you.

Packaging materials, be it drums, foils, cartons, etc., are articles within REACH as objects that are given a special shape, surface or design during production that determines their function. Therefore, the following applies:

Registration and Notification of Substances in Articles

Any producer or importer of articles shall submit a registration to the agency if:
(a) the substance is present … in quantities totalling over one ton per producer or importer per year
(b) the substance is intended to be released under normal or reasonably foreseeable conditions of use

If a substance is subject to authorization, any producer or importer of articles shall notify the agency if either of the following conditions are met:
(a) the substance is present in those articles in quantities over one ton per producer or importer per year
(b) the substance is present in those articles above a concentration of 0.1 % weight by weight (w/w).

Conclusion A: In packaging itself, there is no substance that is intended to be released and no registration is required for packaging.

Conclusion B: If packaging contains a hazardous substance than a notication is requested above those concentration limits.

Packaging of food materials is regulated in Europe. Additives that are subject to authorization should be excluded from use. I use ‘should’ as I am not sufficiently knowledgeable of all the requirements for food packaging laws; however, this seems logical to me. I do not think a similar regulation exists for pharmaceutical packaging.

General Conclusion: Packaging is an article under REACH and not exempt for any application. Therefore, food and pharma packaging is part of REACH. It has to be checked, if the packaging contains any hazardous ingredients within the concentration limits given in the regulation. Most likely, that is not the case for food and pharma packaging; therefore, most likely no action is required.

Thank you for that question. The answer is logical within the REACH regulation; however, it reminded me that sometimes it takes a deep breath and discussion partners to get over all intellectual hurdles

Q.Do you have a list of ingredients submitted for approval?
- Heshi MahinRod, March 07, 2008
A.A list like that does not exist. REACH requests for manufacturers and importers in the EU to register their substances. You have to determine if your company has obligations within REACH and if you have to evaluate your product portfolio in order to determine those substances that require registration. For this evaluation, please read my colum in C&T today to get started started.
Q.Dear Madam, I am a non-EU company. I would like to ask you a few questions which I am not sure about and I would like to know your comments on these issues. My question is if packaging materials of medicine products , food and also food additives are being exempted from Registration (Title II), information in the supply chain (Title IV), Downstream users (Title V) ,Evaluation (Title VI) and Authorisation (Title VII) obligations like medicine, food and food products? Are their realated Directives include their packaging materials too? And what about the cosmetics product and their packaging materials? Which obligations are we responsible about the packaging material under REACH? Thank you for now
- Ozlem, March 05, 2008
A.

This is an interesting question. Basically, packaging material is included in the obligations for REACH. In Europe, it is not so important for the sectors you mention because the materials get registered by an actor up the supply chain. For non-EU companies, it is more complicated, as that is most often not the case. Than the assessment starts, polymer, monomers, quantities, etc. In my experience the 1 ton limit often is not reached.

To address your question concerning packaging for sectors that are exempt from REACH, I want to suggest to you to discuss that with a representative from the ECHA, whom I will be meeting on Wednesday. I will get back to you by the end of this week.

Q.demand for cosmetic in india
- Shinky, March 05, 2008
A.

Is your question: Do cosmetic manufacturers in India have obligations for REACH?

It is the EU importer who has to register the ingredients above 1 ton if these have not been registered by an individual up the supply chain. You may appoint an representative to fulfill all obligations in your name.

If you have further questions, please ask these through the C&T  REACH Roundtable.

Q.We are a non-EU company that exports blends of polymers to the EU. If the polymers meet the requirements under the "Polymer Guidance" section, are we exempt from registration? Is documentation required? Do we need an OR?
- Anonymous, February 27, 2008
A.

If a substance fulfills the polymer criteria, no action is necessary for pre-registration or registration of the polymer substance. Potential steps towards authorization need to be taken where a substance is identified as being of very high concern by the European authorities, e.g. the European Chemicals Agency. Additionally, all requirements where a substance or preparation meets the criteria for classification as dangerous acc. to the Directive on Dangerous Substances (67/548/EEC or 1999/45/EC) fully apply.

!! Furthermore, manufacturers and importers of polymer substances and polymers in preparations have to assure, that all monomers and other chemically bound substances are registered within the following conditions:

-the polymer consists of 2% weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) 
- the total quantity of such monomer substance(s) or other substance(s) makes up one tonne or more per year.

As you are a non-EU manufacturer, your monomers are most likely not registered by an actor up the supply chain. Your importer into Europe is responsible for the registration. You may appoint an Only Representative to fullfill the obligations, the advantage of an OR is the following:

The non-EU Manufacturer
- is not bound to one European importer
-cooperates with only one REACH focal point
-does not disclose confidential data to customers/importers
-does not supply complete formula information to European importers.

Q.The REACH nomenclature rules may redefine a product such that it is no longer on EINECS or have an EC number. The new name may not be on EINECS or may not even have a CAS #. If this is the case, can the product still be pre-registerd? If so, under what identifying number (e.g., CAS, EC number, etc.)? Will a new EC number be created or will the current EC number be used and redefined?. An example: Product A is currently listed on EINECS as C12-18 alkyl amide and has been sold in the EU in the past. Using the nomenclature rules in REACH, Product A is now defined as C12-14 alkyl amide and no longer listed on the European inventory. Can Product A still be pre-registered?
- Anonymous, February 27, 2008
A.

I may not understand your question properly, as I have not come across a problem such as yours before. 

The REACH nomenclature rules may redefine a product so that it is no longer on EINECS or have an EC number

My answer:
a) The substance definition in REACH is identical to the definition of a substance that is currently used under the 7th Amendment of the Dangerous Substances Directive (Directive 92/32/EEC amending Directive 67/548/EEC) (see GUIDANCE ON PRE-REGISTRATION AND DATA SHARING, page 25)

b) For pre-registration the substance identification requirements, REACH does not require a full identification dossier in line with item 2 of Annex VI, but requires only that the potential registrant gives the name of the substance or, where applicable, the group of substances, including its EC number and CAS number, if available. (see guidance for identification and naming of substances under REACH, page 16)

Will a new EC number be created or will the current EC number be used and redefined?

There are three lists of substances, EINECS, ELINCS and the NLP-list. In combination they are called the EC Inventory. Each substance in this inventory has an EC number allocated by the European Commission. For more information, visit http://ecb.jrc.it/esis/index.php?PGM=ein.

I recommend, that if you internally redefined your product, that you search in EINECS for the appropriate number, there are 100,204 substances listed. C14-18 is a very common chain distribution and there will be a solution. And pre-registering is a must. 

If this did not meet your needs, pls. submit another mail to the REACH Round Table.

Q.Indigenous women from Africa are commercializing a new cosmetic ingredient based on their traditional knowledge. They have a good commercial partner based in the EU who is willing and able to handle REACH registration. What are the commercial, intellectual property and reputational risks to the women of allowing the commercial partner to do the REACH registration? What are their alternatives?
- Anonymous, February 27, 2008
A.

If the partner is a kosher partner and handling the registration and other business properly, I do not see risks. He is anyway most likely responsible for registration, as most likely he is the importer. It may be recommendable that you appoint an only representative. The advantage of an only representative is:

The non-EU Manufacturer
-is not bound to one European importer
-cooperates with only one REACH focal point
-does not disclose confidential data to customers/importers
-does not supply complete formula information to European importers

Q.Why don't hair dye companies include caps with the gloves for a alternative application?
- Karen, February 27, 2008
A.I am sorry for not giving a targeted answer. But the round table is a REACH forum, and that is my expertise.
Q. I am from a non-EU country. I would like to ask you about the finished cosmetic product registration under REACH. For example a non-EU company produces hand creams to import EU. We know that a non-EU company must register via an OR appointed already by non-EU. So will the cream be registered by an OR as an finished products or the ingredients in it? What does the OR register I mean which one the hand cream or the substances in must be register?
- non-EU, February 22, 2008
A.

The registration (and other obligations) within REACH applies to substances:

… a substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

As you are a non-EU manufacturer, you most likely use ingredients from non-EU suppliers, consequently they have not been registered by someone up the supply chain. Than, the OR appointed by your company has to register (pre-register!!) the ingredients of your cosmetic product. Ingredients may be substances or preparations. Any substance in a preparation has to be registered, except those, where exemptions apply. For exemptions, see Title 1, Chapter 1, Article 2 of the REACH regulation (also Article 9, Article 15, Article 24, etc.). Be alert about polymers as monomers have to be registered.

Q.Are there exemptions for cosmetic ingredients under REACH?
- Anonymous, February 12, 2008
A.

Manufacturers are responsible for ingredients used in cosmetics and personal care and they must comply with all provisions of REACH—no general exemption applies. However, ingredients often fall under exemptions specifically described in the various articles and annexes of the REACH regulation. Therefore, before pre-registration or registration, the following sections of the regulation have to be researched carefully, as many substances described here are used as cosmetics and personal care ingredients:
- Annex IV: substances causing minimum risks
- Annex V: incl. substances occurring in nature, etc.
- Article 15: substances regarded as being registered, including biocidal products
- Provisions for polymers (and monomers)

Further specific provisions for cosmetics and personal care ingredients apply at later stages of REACH:
- The Chemical Safety Report (CSR), which needs to be submitted for registration of substances manufactured or imported in quantities above 10 tons, does not need to include considerations of the risks to human health for consumers when the substance is used in cosmetic products within the scope of the Directive 76/768 or the Cosmetics Directive
- Substances included in Annex XIV—List of substances subject to authorization—cannot be authorized for use in cosmetics or personal care because they were included in the annex due to identified hazards to human health
- The restrictions in Annex XVII that are addressing risks for human health do not apply to the use of cosmetics and personal care ingredients within the scope of the Directive 76/768

Under the Directive on Dangerous Substances (Article 1 of Directive 67/548 as amended by Directive 92/32), non-EINECS listed ingredients did not have to be notified if the were placed on the market as cosmetic products in their final form, intended to be used by consumers. This no longer applies under REACH and these ingredients, when manufactured or imported in quantities above 1 ton, have to be registered, if not falling under an exemptions as described above, as of June 1, 2008. Extended registration deadlines do not apply since these ingredients are not phase-in substances.

The Seventh Amendment of the Cosmetics Directive 76/768 prohibits the performance of animal tests on ingredients for cosmetics and personal care after March 2009. REACH addresses this issue in Article 2(4)(b)—this regulation shall apply without prejudice to Directive 76/768/EEC as regards testing involving vertebrate animals within the scope of that Directive, and Recital 13—a phase-out of testing on vertebrate animals for the purpose of protecting human health as specified in Directive 76/768/EEC should take place with regard to the uses of those substances in cosmetics.

Q.We are a manufacturer of preparations and located outside of the EU but we have a subsidiary within the EU. Can this subsidiary fulfill the obligations under REACH?
- Anonymous, February 12, 2008
A.If the subsidiary is a separate legal entity to the parent company, i.e., natural or legal as defined under applicable national law, then it may fulfill the obligations under REACH.
Q.Do I have to pre-register my substances?
- Anonymous, February 12, 2008
A.Only phase-in substances can be pre-registered. Pre-registration allows companies to continue manufacturing and importing their phase-in substances for several years until the registration deadline is reached. These deadlines do not apply to non-preregistered phase-in substances.