On Dec. 9, 2009, the European Union (EU) published Regulation (EC) No. 1223/2009, which will go into effect on Jan. 11, 2011.1 The first part of this three-column series focused on the Cosmetic Product Safety Report section of the regulation. It appeared in the August 2010 issue of Cosmetics & Toiletries magazine.2 This second part discusses the remainder of the regulation, save for a third part describing issues regarding the Responsible Person (RP). In total, EC No. 1223/2009, often called the Recast or the 8th Amendment, is comprised of a preamble with 71 parts (justification), 40 articles (replacing the old 15) and 10 annexes (replacing the old nine).
While EC No. 1223/2009 goes into effect in January, manufacturers should begin complying with it as soon as possible. Additional effective dates for EC No. 1223/2009 include: Dec. 1, 2010, for regulations concerning carcinogens, mutagens and reprotoxic (CMR) substances; 2011 in general, when automated notifications are expected to begin updating the European Commission (EC) for both business conducted in the EU and poison control information; Jan. 11, 2013, for regulations on nano-sized ingredients; and July 11, 2013, by which all products must be in full compliance with the regulations.
Changes in EC No. 1223/2009
The preamble to the regulation offers a number of justifications for changes made to the Cosmetics Directive 76/768/EEC. As discussed in the previous column, the EU has changed the legislation from being a directive, requiring its incorporation into each country’s national laws, to a regulation, which then becomes uniform across all Member States of the EU.
Notification process: EC No. 1223/2009 aims to simplify the notification process. Previously, poison control information including the manufacturer’s address as listed on the product label was sent to the country in which it would be sold. Further, some Member States such as France and Spain required local notification, with France specifically requiring three poison control center notifications. In this author’s view, reducing the number of notifications and poison control filings to only one, and doing so electronically, indeed does simplify the procedures; however, the remainder of EC No. 1223/2009 makes the process more complex.
Definitions: EC No. 1223/2009 defines cosmetic products, and this legal definition has not changed; however, Annex I of the Cosmetics Directive, which was an illustrative list of cosmetic categories to clarify definitions, is now included as a part of an article rather than being its own annex. Annexes allow for changes to be made by Adaptations to Technical Progress (ATP), which are issued by the EC; articles may only be changed by amendments.
EC No. 1223/2009 states the EC will review each product on a case-by-case basis to determine if it is a cosmetic. Since the EC can change annexes, it was previously easier to deem a product a cosmetic. Now that pre-approved product categories are included in an article, cosmetic companies must match their products to them. If a cosmetic product does not fit a definition, the EC will decide whether the product is allowed, which could result in delays or even put the sale of such products in jeopardy as the regulations are enforced locally.
Food vs. cosmetics advertising: The regulation states that both the physical and advertised presentation of a cosmetic product must clearly indicate it is not a food, to avoid placing consumers’ health at risk. This is interesting since there are several large retail brands, one in particular in the UK, that sell cosmetics that in this author’s opinion resemble food and are sold in what look like food stores.
Responsible person: As noted, EC No. 1223/2009 establishes the concept of a Responsible Person (RP), who manages the majority of a product’s compliance. This is a complicated part of the regulation and will be covered in full detail in a third part to this series. It should be noted, however, that the RP’s role is to trace the entire supply chain of a product. The RP also is responsible for reporting safety information on the use of nano-sized ingredients to the Scientific Committee on Consumer Safety (SCCS). Finally, the RP is responsible for reporting all serious undesirable effects to the local authorities.
Cosmetic distributors: The regulation also establishes the requirements of cosmetic distributors, who probably never dreamed of coming under such complex regulations; for instance, cosmetics are now required to be manufactured under Good Manufacturing Practices (GMPs) under the regulation.
Product safety: As discussed in the first part of this series, the Product Information Package (PIP), sometimes called a dossier, must include the Product Safety Report, and existing PIPs must be revised to comply with this regulation. The Product Safety Report must include a complete safety assessment, which is different from current requirements. In addition, the competent authorities must be notified when cosmetics are placed on the market, and poison control centers must have access to formulations, both of which will soon be completed electronically to the EC.
Also regarding product safety, EC No. 1223/2009 states that the precautionary principle should be used as the basis by which the EC and Member States provide for human safety, which is highly debated. This principle is the notion that a product is unsafe until proven safe, and while it has always been a guiding concept, it is now a regulation. Member States therefore are required to establish penalties for violations that are effective, proportionate and dissuasive.
Further, the regulation states that the safety of a cosmetic can be determined by the safety of its ingredients, which is questionable since it overlooks chemical reactions or interactions that take place; for instance, the solubility of some ingredients may allow or prevent the penetration of others into the skin. This approach has in part been justified by being a time saver, especially when considering the timetable by which the testing of cosmetic ingredients on animals must be eliminated.
Also relating to safety, period after opening (PAO) is defined in the regulation, which incorporates the EC’s recommendation that PAO not be required for products such as single-use applicators, products consumers do not touch, i.e., aerosols, and products not at risk for deterioration. This author wonders how a company would prove a product is not at risk for deterioriation.
Mixture vs. preparation: Under EC No. 1223/2009, mixtures and preparations are considered the same but clearly the EU has not considered in situ reactions, which are common in creams and lotions. The results of these reactions are neither mixtures nor preparations. For example, triethanolamine (TEA) is a strong base that is irritating to the skin but when mixed with stearic acid in a formulation, it reacts to form TEA stearate, a safe and non-irritating emulsifier and cleanser.
Prohibited and allowed ingredients: The regulation lists restricted and prohibited ingredients as part of Annex II (prohibited), III (restricted), IV (permitted colors), V (permitted preservatives) and VI (permitted UV filters). It further clarifies that the list of allowed colorants contained in Annex IV includes only substances that impart color via absorption and reflection, and not substances that impart color through photoluminescence, interference or chemical reaction. With this clarification, hair colorants move from the restricted list (Annex III) to the permitted list (Annex IV).
The regulation also addresses the need to frequently review the safety of nanotechnology and nano-sized ingredients, and establishes how Categories 1A, 1B and 2 CMR substances, which currently are prohibited from cosmetics, are allowed—i.e., if they are naturally found in foods and there are no suitable replacements.
Product claims: EC No. 1223/2009 states that the EC should determine the criteria for product claims, thereby dictating how companies justify their advertising claims. The criteria will be determined by listing the required tests and results required to make given claims; this author feels this approach will surely discourage innovation.
The New Articles
To coordinate the 40 new articles in EC No. 1223/2009, they are divided into 10 chapters, which are described here.
Chapter I (scope and definitions): Article 1 lists the scope and objective while Article 2 includes 19 definitions for entities including: a cosmetic, substance, mixture, manufacturer—i.e., the company whose name is on the label, distributor, nanomaterial—i.e., an insoluble material manufactured with one or more dimensions from 1 to 100 nm, preservative, colorant, UV filter, undesirable effect and frame formulation, among others.
Chapter II (safety, responsibility and free movement): This chapter includes Article 3 on safety, Article 4 regarding the RP, Article 5 on obligations of the RP, Article 6 discussing obligations of distributors, Article 7 on identification within the supply chain, Article 8 regarding GMPs, and Article 9 on free movement.
Chapter III (safety assessment, product information file and notification): Article 10 on safety assessment, Article 11 covering product information files, Article 12 on sampling and analysis, and Article 13 regarding notification are included in this chapter.
Chapter IV (restrictions for certain substances): Chapter IV consists of Article 14, on restrictions for substances listed in the annexes; Article 15, on CMR substances; Article 16, covering nanomaterials; and Article 17, discussing traces of prohibited substances.
Chapter V (animal testing): This chapter is dedicated solely to Article 18 on animal testing. Chapter VI (consumer information): This chapter includes Article 19 covering labeling, Article 20 on product claims, and Article 21 on access to information for the public.
Chapter VII (market surveillance): Chapter VII discusses Article 22 on in-market control, Article 23 regarding communication of serious undesirable effects, and Article 24, i.e. information on substances.
Chapter VIII (Noncompliance and safeguard clause): Article 25 on noncompliance by the RP; Article 26 on noncompliance by distributors; Article 27, i.e. the safeguard clause; and Article 28 covering good administrative practices are covered by Chapter VIII.
Chapter IX (administrative cooperation): Article 29 discussing cooperation between competent authorities, and Article 30 on cooperation regarding verification of product information files are covered by this chapter.
Chapter X (implementing measures and final provisions): Finally, Article 31 on amendment of the annexes; Article 32 on committee procedures; Article 33 providing a glossary of common ingredient names; Article 34 covering competent authorities, poison control centers or assimilated entities; Article 35 regarding an annual report on animal testing; Article 36 on formal objection against harmonized standards; Article 37 covering penalties; Article 38 on repeal; Article 39 describing transitional provisions; and Article 40, i.e. entry into force and date of application, are all included in Chapter X. The New Annexes As noted, Annex I, the Cosmetic Product Safety Report, was previously reviewed;2 therefore, the present discussion will focus on Annexes II–X.
Annex II—List of Substances Prohibited in Cosmetic Products: Under EC No. 1223/2009, Annex II is the same as it is under the Cosmetics Directive; however, the EU has made it even more difficult to use. Chemicals are listed by their reference number, followed by the International Union of Pure and Applied Chemistry (IUPAC) name rather than INCI name. The reason for this is likely because few prohibited chemicals have INCI designations since they are in fact prohibited from use in cosmetics. When the regulation was published, 1,328 chemicals were listed and more have already been added. Of the chemicals prohibited in cosmetic products, the chemicals of interest to the cosmetic formulator are listed in Table 1.
Annex III—List of Substances Which Cosmetic Products Must Not Contain Except Subject to the Restrictions Laid Down: Under EC No. 1223/2009, Annex III also is the same as it is under the Cosmetics Directive. It includes 256 restricted ingredients. Like Annex II, it lists these by a reference number and IUPAC name, and sometimes INCI name. Here formulators will find fragrance allergens, and their restrictions and labeling. Also listed are the approved hair dye agents. While the preamble allows for moving these hair dye agents to a separate part of the permitted colors, this has not yet been changed.
Annex IV—List of Colorants Allowed in Cosmetic Products: Annex IV is again the same under EC No. 1223/2009 as it is under the Cosmetics Directive. The chemicals here are also listed by reference number followed by the IUPAC name and the Color Index (CI) number. The INCI names required by the US Food and Drug Administration are not listed. There are 153 listed colors, and these include the lakes of these colors. EC No. 1223/2009 has replaced the four fields of application in the Cosmetics Directive with a column marked product type and body parts to indicate the same information as before but in a simpler way.
Annex V—List of Preservatives Allowed in Cosmetic Products: This annex replaces Annex VI in the Cosmetics Directive. There are no changes from the old list of 56 approved preservatives.
Annex VI—List of UV Filters Allowed in Cosmetic Products: This annex replaces Annex VII in the Cosmetics Directive. Again, the chemicals are listed by a reference number and IUPAC name, followed by the INCI name; 28 materials are listed. It is curious that PABA is listed when it has been delisted as an approved UV filter by the EC for lack of support.
Also in this annex, the warning for benzophenone-3 has been changed from “contains oxybenzone” to “contains benzophenone-3.” Titanium dioxide is listed as a permitted UV filter but zinc oxide is not. The interpretation of this is that when titanium dioxide is used as a UV filter, it should be listed in descending order of predominance, i.e. as “titanium dioxide.” If it is used as a color, it is listed at the end as “CI 77891.” What should a manufacturer do if titanium dioxide serves as both a UV filter and a pigment in a product? Under this regulation, zinc oxide can only be used as a colorant.
Annex VII—Symbols Used on Packaging: This annex replaces Annex VIII in the Cosmetics Directive, with the addition of a third symbol—i.e., the date of minimum durability, which is shown in Figure 1. This date replaces the “best used by …” statement and includes a month and year listed beneath it. In general, the symbols used on packaging refer to enclosed or attached information and the PAO as well as date of minimum durability.
Annex VIII—List of Validated Alternative Methods to Animal Testing: This annex is the same as Annex VIII of the Cosmetics Directive and in both cases is empty. This author finds the lack of animal-alternative test methods odd because manufacturers are required to use such tests in place of animal testing.
Annex IX—Part A, Repealed Directive with its successive amendments; Part B, List of time for transposition into national law and applications: Annex IX, including repealed directives, is useful as it shows what old regulations will no longer be in effect.
Annex X—Correlation Table: This annex correlates the new regulations to what they replace in the Cosmetics Directive.
While some believe that EC No. 1223/2009 is a great improvement, this author finds only three positive aspects to the regulation. The first is that all Member States will have the same rules, which will make life easier. The second and third good points are the centralized electronic cosmetic and poison control notifications. These will eliminate repetitive filings of the same information; and from a regulatory control position, the Member States’ competent authorities will have a central place to find the information they need. Many of the other changes will be time-consuming for cosmetic chemists, regulatory specialists, toxicologists, raw material marketers and the EC.
Another criticism is that this would have been the perfect time to define borderline cosmetic products. EC No. 1223/2009 applies to cosmetics only; not medicinal products, medical devices or biocidal products. However, the EU unfortunately did not address this critical area3 and Member States can regulate borderline cosmetics as they see fit, which defeats the purpose of having one harmonized regulation that is applicable to all countries.
Such borderline products may include: antimicrobial products, i.e. anti-fungals for skin and nails, antibacterial cleansers and leave-on products and hand sanitizers; hair growth products; dandruff products; teeth whiteners; antiaging products; exfoliants; acne products; anticellulite products; massage products; skin whiteners; insect repellents; and aromatherapy. By not clearly establishing under what conditions these products are considered cosmetics, the EC must now deal with them individually. This disregard places cosmetic companies in jeopardy of not knowing whether their product is a cosmetic, drug or consumer product, etc.—and these different product types have different regulations.
Further, the mandate for a new safety assessment will require all existing safety assessments to be conducted again. One wonders whether findings from a safety assessment performed last year will be any different from findings in 2013; perhaps manufacturers can say that a product is safer than safe. In addition, had the authors of this regulation ever actually made cosmetics, they would know better than to assume that if the ingredients in a product are safe, the final product combining them will also be safe.
In this author’s opinion, the strangest addition to EC No. 1123/2009 is the CMR escape clause; one wonders what the EU will do when alcohol is correctly classified as a carcinogen and as toxic to reproduction, since it is the major cause of birth defects and liver cancer.4 According to the Cosmetics Directive, alcohol would be banned. However, the EC’s escape clause explains that if a product is found naturally in foods—for example, if wine were considered a natural food—and there is no substitute, then it may be allowed. But is there no substitute? In the late 1980s, any use of alcohol was forbidden in one Muslim country, thus isopropyl alcohol was substituted for alcohol in hair sprays, fragrances, etc. It had a sharp, biting odor but was used since it served as a substitute.
The answer is that CMRs are directly linked to exposure route. Alcohol is toxic to reproduction only via ingestion by pregnant women, and is only a carcinogen by ingestion. Neither route is relevant to its use in cosmetics. The escape clause will allow the EU to get around the banning of alcohol—but how will the group deal with titanium dioxide, which is not found naturally in foods although it is used in foods worldwide? Cosmetic formulators could use other white colorants; for instance, Annex IV lists 10 other white pigments. Perhaps formulators should just revert to what was used before titanium dioxide to make white paint—lead carbonate.
Another part of this regulation that shows lack of scientific support is the EC’s definition of nanomaterials. Rather than waiting for the International Cooperation of Cosmetic Regulations (ICCR) to arrive at a definition that everyone agrees upon, here the EU has defined a nanomaterial as being an “insoluble material manufactured with one or more dimensions from 1 to 100 nm.” A sheet of paper 1 nm thick would meet this definition but it could never penetrate the skin.
Finally, the other critical questions around nanotechnology are never mentioned. The first issue is that there is a general consensus that a nanoparticle must be manufactured at nano-size; i.e., a micro-sized particle cannot be ground down to make a nanoparticle. Thus, a nanoparticle is manufactured, measured somehow, then placed into a solvent. Once in the solvent, agglomeration takes place. So the next question becomes: Is the particle still a nanoparticle? And even if the formulator or raw material supplier is able to prevent this agglomeration from happening, when the cream is placed on the consumer’s skin, agglomeration takes place before there is penetration. Are the particles in this cream still considered nano-sized? These are but a few of the critical questions that must be resolved before regulations are promulgated.
The discussion on EC No. 1123/2009 could continue for quite some time, and it reminds this author of an old joke. Question: What’s the definition of a camel? Answer: A horse designed by a committee.
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/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF (accessed Oct 6, 2010)
2. DC Steinberg, EU Regulation No. 1223/2009 Part 1: Product Safety, Cosm & Toil 125(8) 18—24 (2010)
3. Cosmetic Products-Borderline Situations: Council of Europe Publishing (2001)
4. Alcohol Use and Cancer, The American Cancer Society, http://www.cancer.org/Cancer/CancerCauses/DietandPhysicalActivity/alcohol-use-and-cancer (accessed Oct. 27, 2010)