Understanding the Cosmetic Products Regulation 1223/2009 and REACH

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1 1 Understanding the Cosmetic Products Regulation 1223/2009 and REACH Dr. Annelie Struessmann, Technical Director, CONUSBAT London, 15. October 2013

2 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 2 Agenda EU Sector Industry Legislation Key Elements of REACH and the CPR Interfaces for the Regulatory Frameworks Testing Requirements from REACH The Animal Testing Ban Conclusions - Q & A

3 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 3

4 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 4 The Single or Internal Market The internal market is the core of today s European Union and as a consequence people, goods, services and money move around as freely as they do within one country.

5 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 5 The Single Market for Goods Regulated Industry Sectors 1. Automotives 2. Chemicals 3. Construction products 4. Cosmetics 5. Return of cultural goods 6. Defense related products 7. Electrical equipment 8. Equipment intended for use in Potentially Explosive Atmospheres (ATEX) 9. Footwear 10.Gas Appliances 11.Medical devices 12.Mechanical equipment (machinery, lifts) 13.Metrology and pre-packaging 14.Pharmaceuticals 15.Pressure equipment 16.Radio and telecommunications terminal equipment (R&TTE) 17.Rail 18.Textiles 19.Toys 20.Weapons and many others

6 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 6 THE ABC OF EUROPEAN UNION LAW* *

7 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 7 REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.

8 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 8 REACH > > > > Registration, Evaluation, Authorization and Restriction of Chemicals > Pre-market approval

9 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 9

10 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 10 Cosmetic Products Regulation (CPR) The Cosmetics Regulation requires that every cosmetic product placed on the market in Europe is safe to use. The manufacturer must ensure that cosmetic products undergo an expert scientific safety assessment before they are launched for sale. > In-market Surveillance

11 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 11

12 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 12 REACH - Preamble 13 This Regulation should apply without prejudice to the prohibitions and restrictions laid down in Council Directive 76/768/EEC* of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products in so far as substances are used and marketed as cosmetic ingredients and are within the scope of this Regulation. 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. *[Regulation (EC) Nr. 1223/2009]

13 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 13 REACH - Preamble 13 This Regulation should apply without prejudice to the prohibitions and restrictions laid down in Council Directive 76/768/EEC* of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products in so far as substances are used and marketed as cosmetic ingredients and are within the scope of this Regulation. 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. *[Regulation (EC) Nr. 1223/2009]

14 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 14 SUMMARY: Regulation (EC) Nr. 1223/200 is the decisive framework for Cosmetic Products The Cosmetics Product Regulation contains legal provisions for the product ingredients (ingredient lists in the CPR s annexes), for product labelling and on animal testing. Also, the identification and labeling of hazardous substances is regulated in the CPR. REACH APPLIES TO COSMETIC INGREDIENTS, BUT NOT TO COSMETIC PRODUCTS COSMETIC PRODUCTS -MIXTURES IN THE FINISHED STATE, INTENDED FOR THE FINAL USER- ARE EXEMPT FROM ALL PROVISIONS OF CLP

15 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 15 REACH > > pre-market approval Test Requirements for Registration > 1 t/a > 10 t/a > 100 t/a > 1000 t/a Price Annex VII Annex VIII Annex IX Annex X Euro Acute oral X X X X Acute dermal X / O X/O X/O Acute inhalative X /O X/O X/O Skin irritation X X X X Eye irritation X X X X Sensitization X X X X Ames assay X X X X Chromosome aberration O X X X Additional mutagenicity studies O X X X Reprotox Screening X Teratogenicity X X day test X O day test X X Chronic study O generation study O O Carcinogenicity study O Source: Regulatory Workshop InCosmetics 2011 M.Kleber O: Involves an expert decision

16 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 16 Cosmetic Products Regulation (CPR) Manufacturer Responsibility for Product Safety Cosmetic Product Safety Assessment RELEVANT TOXICITY STUDIES ON COSMETIC SUBSTANCES* > In-market Surveillance 1 Acute toxicity... 2 Corrosivity and irritation... 3 Skin sensitization... 4 Dermal / percutaneous absorption... 5 Repeated dose toxicity... 6 Reproductive toxicity... 7 Mutagenicity / genotoxicity... 8 Carcinogenicity... 9 Toxicokinetic studies Photo-induced toxicity Human data... *SCCS - Notes of Guidance for the Testing of Cosmetic Substances and their Safety Evaluation, 8th Revision

17 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 17 Comparison of Test Requirements REACH CPR Acute oral Acute toxicity Acute dermal " Acute inhalative ' Skin irritation Corrosivity and irritation Eye irritation " Sensitization Skin sensitization Ames assay Mutagenicity/genotoxicity Chromosome aberration ' Additional mutagenicity studies ' Reprotox Screening Reproductive toxicity Teratogenicity ' 28 day test Repeated dose toxicity 90 day test ' Chronic study ' 2 generation study ' Carcinogenicity study Carcinogenicity Dermal / percutaneous absorption Toxicokinetic studies Photo-induced toxicity Human data

18 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 18 Ban on Animal Testing

19 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 19 IMPLEMENTATION DEADLINES Testing ban on finished cosmetic products 11 Sept Testing ban on ingredients or combination of ingredients 11 March 2009 Marketing ban when tested for human health effects with 11 March 2009 the exception of the specific effects of repeated-dose toxicity, reproductive toxicity and toxicokinetics Marketing ban when tested on the specific effects 11 March 2013 The ban applies irrespectively on the availability of alternative non-animal tests Ban on Animal Testing

20 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 20 REACH - Information Requirements, Test Methods and Quality of Data Article 13(3) of the REACH Regulation requires that new tests need to be performed acc. to the test guidelines in Regulation (EC) No. 440/2008* or in accordance with other international test methods recognized by the European Commission or ECHA. *

21 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 21 Status on Validation of In-Vitro Alternatives to Animal Testing Acute systemic toxicity Recommendations Skin irritation / corrosion Validated in vitro test methods Eye irritation Validated in vitro test methods + peer reviews Sensitization Peer reviews Mutagenicity/genotoxicity Validated in vitro test methods Reproductive toxicity Peer reviews and foreseen validations & accepted methods Repeated dose toxicity - Carcinogenicity study Recommendations and drafts Dermal / percutaneous absorption Validated in vitro test methods Toxicokinetic studies Peer review Photo-induced toxicity Validated in vitro test methods EU COMMISSION COMMUNICATION on the animal testing and marketing ban March 2013: Tracking System for Alternative test methods:

22 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 22 Other Alternatives to Animal Testing - in-silico, in-chemico methods ADVERSE OUTCOME PATHWAYS

23 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 23 CONCLUSIONS The future of safety assessment for cosmetic ingredients and other chemicals is a multi-tier approach of using in-vitro, in-silico and in-chemico methods. Actually, many elements are available, however, some are still under exploration. Multi-tier approaches will assure compliance with REACH and the CPR. The animal testing ban does not apply to chemicals with application in other areas than cosmetics - therefore, no break in seeking REACH compliance exists. This includes chemicals used as cosmetic ingredients when multiple applications exist. For many new cosmetic ingredients the existing alternatives already allow for a comprehensive safety assessment according to Annex I/CPR - read-across and tests on humans are examples for data sources in weight-of-evidence approaches which can be used in addition to alternative testing. As REACH applies only from a threshold of 1 tonne/year, cosmetics assessed in a WoE approach can be introduced into the EU internal market. Delays in innovation due to the animal testing ban will appear in only minor dimensions.

24 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 24 Costs? - Facts An increased demand for experts and science sector specialists is required. The number of tests and costs per test will be reduced. An issue is the availability of experts. When comparing costs for a multi-tier alternative approach Ban to a on set Animal of animal tests Testing priorly used they appear to be in similar dimension.

25 Understanding the Cosmetic Products Regulation 1223/2009 and REACH 25 Dr. Annelie Struessmann Kruppstr. 18 D Aachen, Germany Tel: Skype: annelie.struessmann