EU Regulation No. 1223/2009 Part 1: Product Safety

The European Union (EU) has published the long-awaited Regulation No. 1223/2009 on Dec. 22, 2009. At 151 pages, it is a lengthy read and when it goes into effect on July 11, 2013, it will make the EU the most highly regulated cosmetics industry in the world. While it is sometimes referred to as the 8th Amendment to the Cosmetic Directive 76/768/EEC or the Recast, its correct designation is Regulation No. 1223/2009.1 Many people have written about Regulation No. 1223/2009 and industry associations seem to view the regulation optimistically. Truth be told, however, this regulation offers few improvements over the previous directive.

As noted, Regulation No. 1223/2009 is a regulation and no longer a directive. While a directive must be encompassed in the local regulations of Member States, a regulation supersedes all local laws. This prevents Member States from adapting regulations for their purposes, and from forcing companies to monitor and comply with regulations for 27 different countries rather than one EU directive. This eliminates the confusion that stemmed from adaptations such as: the UK defining who is qualified to be a safety assessor; France requiring Poison Control Center notifications on its forms; Belgium charging to register a formulation; and Spain requiring notification even if the product manufacturer does not have a Spanish address on the label. Now, cosmetic manufacturers need only be concerned with one registration and one Poison Control notification, both of which will be submitted electronically, and Member States cannot change or enhance these regulations. That’s the good news.

The bad news is that, in this author’s opinion, an already poor regulation was retained, albeit with a slight change in phrasing: The requirement for a cautionary statement on a product label when it contains more than 0.5% benzophenone-3. When a product met this requirement, the warning: Contains oxybenzone was required to appear on the label. While oxybenzone is the drug name for the INCI designation benzophenone-3, a consumer in the EU might look at a product label, see this warning and scan through the ingredient listing only to find no oxybenzone listed there. Regulation No. 1223/2009 changes the phrasing of this warning to now read: Contains benzophenone-3, to match the way it appears in the ingredient disclosure.

The present column focuses on a portion of Regulation No. 1223/2009 that both finished product manufacturers and ingredient suppliers will need to begin work on to prepare for 2013: the safety report. The requirements for this report will be time consuming and costly, thus companies are advised to begin evaluating their products and positions to determine if the safety report requirements will render some products cost-ineffective. Whether it does or not, companies should begin allocating both financial and human resources to prepare for the compliance timelines and requirements, as are described below.

Readers should note that this discussion of Regulation No. 1223/2009 consists of three main parts: the Preamble, which explains changes to the original Cosmetics Directive; followed by Articles and Annexes.

Product Safety Under the Cosmetics Directive
In the Cosmetics Directive under Article 7a, the following information must be included on the product label for the competent authority to inspect and review. This has become known as the Product Information
Package or the dossier. Under the new Regulation No. 1223/2009, this information has been retained as preamble item 7, albeit with several changes.

Qualitative and quantitative compositions: The qualitative information includes the INCI names of the ingredients and the quantitative description is the exact amount of each present. In fragrance compositions, the name, code and identity of the supplier should be provided.

Microbiological details: The physical, chemical and microbiological specifications of the raw materials used must be provided, in addition to the microbiological specifications of finished product and the microbiological control criteria for the product.

Method of manufacture: The method of manufacture provided must comply with good manufacturing practices (GMPs) and those responsible for manufacturing must have the required education or experience to meet this requirement.

Safety assessment: The human health safety assessment of the finished product must be provided. This should take into consideration the general toxicological profile of the ingredients, their chemical structure and levels of exposure. The assessment should pay special attention to the specific exposure characteristics of the anatomical sites to which the product will be applied, or to the population for which the product is intended. Among other things, a specific assessment should be carried out for cosmetic products intended for use on children under the age of three, and for cosmetic products intended for use in external intimate hygiene.

Safety assessor: The name, address and qualifications of the safety assessor must be indicated.

Undesirable effects: Data on undesirable effects on health from use of the product must be provided.

Proof of claims: The EU requires that product manufacturers include proof for all product claims made. For example, an anti-fade shampoo for colored hair should include evidence that using the product prevents hair from fading; and a moisturizing lotion should include proof that it moisturizes skin.

Animal testing: For the evaluation of safety, data on all animal testing must be provided by the manufacturer, agents and suppliers involved in creating the product. It must also include any testing performed to meet legislative or regulatory requirements outside of the EU.

Product Safety Under Regulation No. 1223/2009
As noted, the EU adapted the old Product Information Package to create the new Annex I within Regulation No. 1223/2009. For example, the first major change is that Annex I has been renamed Annex I: The Cosmetic Product Safety Report. To justify changes made to Regulation No. 1223/2009, explanations are outlined in various preambles. Those relating specifically to product safety are detailed here.

Preamble item 19 states: It should be made clear which information is to be made available to the competent authorities. That information should include all the necessary particulars relating to identity, quality, safety for human health and the effects claimed for the cosmetic product. In particular, this product information should include a cosmetic product safety report documenting that a safety assessment has been conducted.

Additional preamble items related to safety include:
(36) Action by the Commission and Member States relating to the protection of human health should be based on the precautionary principle.
(37) In order to ensure product safety, prohibited substances should be acceptable at trace levels only if they are technologically inevitable with correct manufacturing processes and provided that the product is safe.
(41) The safety of finished cosmetic products can already be ensured on the basis of knowledge of the safety of the ingredients that they contain. Provisions prohibiting animal testing of finished cosmetic products should therefore be laid down. The application, in particular by small- and medium-sized enterprises, of both test methods and assessment procedures for relevant available data, including the use of read-across and weight-of-evidence approaches, which do not involve the use of animals for assessing the safety of finished cosmetic products, could be facilitated by Commission guidelines.
(50) In the safety assessment of a cosmetic product, it should be possible to take into account the results of risk assessments that have been carried out in other relevant areas. The use of such data should be duly substantiated and justified.
(51) The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products. In particular, Directive 2005/29/EC of the European Parliament and of the Council of 11 May, 2005, concerning unfair business-to-consumer commercial practices in the internal market (1) OJ L 149, 11.6.2005, p. 22. (1) is applicable. Furthermore, the Commission, in cooperation with Member States, should define common criteria in relation to specific claims for cosmetic products.

In addition to these preamble items, Articles 3, 8, 10 and 11 and Annex 1 address product safety. For the reader’s information, 36 other Articles do not deal with safety and these will be discussed in future columns. The following information on Articles 3, 8, 10 and 11 appears as it is written in the regulation.

Article 3: Safety
A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account of the following: (a) presentation including conformity with Directive 87/357/EEC (products appearing to be other than they are, or endanger the health or safety of consumers); (b) labeling; (c) instructions for use and disposal; (d) any other indication or information provided by the responsible person defined in Article 4. Article 8: GMP 1. The manufacture of cosmetic products shall comply with GMPs with a view to ensuring the objectives of Article 1. 2. Compliance with GMPs shall be presumed where the manufacture is in accordance with the relevant harmonized standards, the references of which have been published in the Official Journal of the European Union.

Article 10: Safety Assessment
1. In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I. The responsible person shall ensure that:
(a) the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment;
(b) an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources; (
c) the cosmetic product safety report is kept up-to-date in view of additional relevant information generated subsequent to placing the product on the market.
The first subparagraph shall also apply to cosmetic products that have been notified under Directive 76/768/EEC. The European Commission, in close cooperation with all stake- holders, shall adopt appropriate guidelines to enable undertakings, in particular small- and medium-sized enterprises, to comply with the requirements laid down in Annex I. Those guidelines shall be adopted in accordance with the regulatory procedure referred to in Article 32(2).

2. The cosmetic product safety assessment, as set out in Part B of Annex I shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by a Member State.

3. Non-clinical safety studies referred to in the safety assessment according to paragraph 1 and carried out after 30 June, 1988, for the purpose of assessing the safety of a cosmetic product shall comply with community legislation on the principles of good laboratory practice, as applicable at the time of performance of the study, or with other international standards recognized as being equivalent by the Commission or the ECHA.

Article 11: Product Information File
1. When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.

2. The product information file shall contain the following information and data, which shall be updated as necessary:
(a) a description of the cosmetic product, which enables the product information file to be clearly attributed to the cosmetic product;
(b) the cosmetic product safety report referred to in Article 10(1);
(c) a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8;
(d) where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;
(e) data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.

3. The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept. The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State.

4. The requirements provided in paragraphs 1 to 3 of this Article shall also apply to cosmetic products that have been notified under Directive 76/768/EEC.

Annex I: The Cosmetic Product Safety Report
Annexes are individual lists that explain how to comply with the Articles. Therefore, regarding product safety, Annex I, Part A describes how to comply with Articles 3, 8, 10 and 11. In addition, while the former Cosmetics Directive indicated that manufacturers should test products for safety, Annex I, Part B of the new Cosmetic Product Safety Report now directs manufacturers as to how to test for product safety.

Part A—Cosmetic product safety information: The cosmetic product safety report should contain at least the following ten components:
1. Quantitative and qualitative compositions of cosmetic products including the chemical identities of substances contained therein as described by chemical name, INCI name, CAS and EINECS/ELINCS numbers, where possible; and their intended function. In the case of perfume and aromatic compositions, descriptions of the name, the code number of the composition and the identity of the supplier are required.
2. The physical and chemical characteristics and stability of the substances or mixtures of the cosmetic product as well as for the product itself. The stability of the cosmetic product should be based on foreseeable storage conditions.
3. Microbiological quality; the microbiological specifications of the substance or mixture and the cosmetic product. Particular attention should be paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under the age of three, and on elderly people or those showing compromised immune responses. The results of preservation challenge testing should also be included.
4. Information regarding the purity of substances and mixtures and information on impurities and trace ingredients about the material; in cases where traces of prohibited substances are present, evidence for their technical unavoidability is required. The relevant characteristics of packaging material, particularly purity and stability, should also be included.
5. Normal and reasonably foreseeable use; the reasoning should be justified in the light of warnings and other explanations given on the product labeling.
6. Exposure to the cosmetic product; data on the exposure of individuals to the cosmetic product should be given, taking into consideration the findings under Section 5 in relation to: The site(s) of application; the surface area(s) of application; the amount of product applied; the duration and frequency of use; the normal and reasonably foreseeable exposure route(s); and the targeted (or exposed) population(s). Potential exposure of a specific population shall also be taken into account. The calculation of the exposure should also take into consideration the toxicological effects to be considered; e.g. exposure may need to be calculated per unit area of skin, or per unit of body weight. The possibility of secondary exposure by routes other than those resulting from direct application should also be considered; e.g. the non-intended inhalation of sprays, non-intended ingestion of lip products, etc. Particular consideration should be given to any possible impacts on exposure due to particle sizes.
7. Exposure to the substances; data on exposure to the substances contained in the cosmetic product is required for the relevant toxicological endpoints, taking into account the information under Section 6.
8. Toxicological profile of the substances; without prejudice to Article 18 (Editor’s note: not shown here), the toxicological profile of substance contained in the cosmetic product for all relevant toxicological endpoints should be included. A particular focus on local toxicity evaluation for skin and eye irritation, skin sensitization, and in the case of UV absorption, photo-induced toxicity should be made. All significant toxicological routes of absorption should be considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL), which should be calculated. According to this requirement, the absence of these considerations should be duly justified. Particular consideration should be given to any possible impacts on the toxicological profile due to particle sizes including nanomaterials, impurities of the substances and raw materials used, and interactions of substances. Any read-across should be duly substantiated and justified, and the source of the information should be clearly identified.
9. Undesirable effects and serious undesirable effects; all available data on the undesirable effects and serious undesirable effects of the cosmetic product or, where relevant, other cosmetic products must be included. This includes statistical data.
10. Information on the cosmetic product; other relevant information, e.g. existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas, should also be included.

PART B—Cosmetic product safety assessment: The following information should be included regarding product safety:
1. Assessment conclusion; i.e., a statement on the safety of the cosmetic product in relation to Article 3 must be included.
2. Labeled warnings and instructions for use; a statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d) must be included.
3. Reasoning; an explanation of the scientific reasoning leading to the assessment conclusion set out under Section 1 and the statement set out under Section 2 must be included. This explanation should be based on the descriptions set out under Part A, and where relevant, margins of safety should be assessed and discussed. According to this requirement, there should also be, among other things, a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene. Possible interactions of the substances contained in the cosmetic product should be assessed. Finally, the consideration and non-consideration of the different toxicological profiles should be duly justified and effects of the stability on the safety of the cosmetic product should be duly considered.
4. Assessor’s credentials and approval of part B; this should include the name and address of the safety assessor as well as proof of qualification of the safety assessor, his/her signature and the date signed.

It is difficult to understand how complex the EU has made Regulation No. 1223/2009. In the United States, cosmetic manufacturers are required to determine the safety of their products or warn consumers. Therefore, the US cosmetics industry is self-regulated, and it is up to those manufacturers to take action. Compare this to the EU, where product safety measures are strictly laid out and must be followed by cosmetic manufacturers. The critical question is: Does the US or EU system assure a safer product on the market? This author does not know the answer, but the EU method is more expensive and there is no evidence that European cosmetics are any safer than American cosmetics.

The statement in the justification that cosmetic products are safe so long as all the ingredients are is curious—this is not good science. It assumes that no chemical reactions take place among ingredients during the process of manufacture and that cosmetics are simple mixtures. Further, it assumes that simply mixing ingredients together does not affect product safety. In fact, this is simple to disprove—just look at the effect a solvent has on the skin irritation of the solid dissolved in it.

Another confusing part of Regulation No. 1223/2009 is the requirement for a microbiology challenge test for all cosmetics. In this author’s opinion, the test is not necessary and is a waste of money. Cosmetics should not be challenge tested if they have a water activity below 0.7. Similarly, nail polish or products with more than 20% alcohol do not require microbiology challenge tests. Why waste money running tests that are not applicable?

The other issue with Regulation No. 1223/2009 is that all safety assessments must be re-run in order to comply with the new requirements. Previously, safety assessments only required a simple statement that the assessor had reviewed the data and expected the product to be safe based on the warnings and directions for use. Now the entire assessment must be justified. One can expect upcoming price increases for safety assessments to rise fast.

In relation, one common complaint about the old directive, which has been addressed by Regulation No. 1223/2009, concerns the qualifications of the safety assessor. The safety assessor is defined as “a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by a Member State.” It is surprising that this regulation considers individuals who have taken a one-week course as equals to individuals with university degrees. A

t the start of this column, it was noted that both raw material suppliers and finished product manufacturers must begin accumulating the required data and running whatever additional tests or reviews are necessary to comply with this revision. This author cannot wait to see what mandatory tests the EU comes up with to prove claims made by manufacturers.

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1. Regulation (EC) No. 1223/2009 of the European Parliament and of the Council, The Official Journal of the European Union, available at http://Eur-Lex.Europa.Eu/Lexuriserv/ uri=OJ:L:2009:342:0059:0209:EN:PDF (accessed Jun 21, 2010)

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