THE EUROPEAN UNION S REGULATORY ENVIRONMENT FOR COSMETICS

THE EUROPEAN UNION S REGULATORY ENVIRONMENT FOR COSMETICS

2 CONTENTS EU Cosmetics Legislation - Area of Applicability Regulatory Modules for Cosmetics Experiences gained with Regulation 1223/2009 Horizontal Legislation Summary

EU Cosmetics Legislation - Area of Applicability 3 THE SINGLE MARKET IN THE EU Free circulation of consumer goods is assured through identical safety standards in the Member States Isabel Ramos BIT Jon Heylings DTI Steven L. Hanft CONUSBAT

EU Cosmetics Legislation 4 THE EUROPEAN ECONOMIC AREA Isabel Ramos BIT Jon Heylings DTI Steven L. Hanft CONUSBAT

Regulatory Modules for Cosmetics 5 A WIDE DEFINITION OF COSMETIC PRODUCTS Source:

Regulatory Modules for Cosmetics 6 THE REGULATION S MODULES CHAPTER TITLE ARTICLES I Scope, definitions 1-2 II Safety, responsible person, free movement 3-9 III Safety Assessment, product information file, notification 10-13 IV Restrictions for certain substances 14-17 V Animal testing 18 VI Consumer information 19-21 VII Market surveillance 22-24 VIII Non-compliance, safeguard clause 25-28 IX Administrative cooperation 29-30 X Implementing measures, final provisions 31-40 Isabel Ramos ANNEXES BIT Steven L. Hanft CONUSBAT I-X

Regulatory Modules for Cosmetics 7 THE REGULATION S MODULES ANNEX I II III IV V VI VII VIII TITLE Cosmetic Product Safety Report List of Substances prohibited in Cosmetic Products List of Substances which Cosmetic Products must not contain except subject to Restrictions laid down List of Colorants allowed in Cosmetic Products List of Preservatives allowed in Cosmetic Products Growth List of UV Filters allowed in Cosmetic Products Symbols used on Packaging/Container List of validated alternative Methods Isabel Ramos BIT

Regulatory Modules for Cosmetics 8 THE REGULATION EXPERIENS GAINED WITH REGULATION 1223/2009 Isabel Ramos BIT

Experiences gained with Regulation 1223/2009 - Substance Regulation Product Information File 9 PIF CONTENTS EU CPR - ARTICLE 11 (i) A description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product (ii) Cosmetic Product Safety Report (iii) A description of the method of manufacturing and a statement on compliance with good manufacturing practice (iv) Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product (v) 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 EU CPR - ANNEX I PART A : COSM. PRODUCT SAFETY INFORMATION Quantitative and qualitative composition of the product Physical / chemical characteristics and stability of the cosmetic product Microbiological quality Impurities, traces, information about the packaging material Normal and reasonably foreseeable use Exposure to the cosmetic product Exposure to the substance Toxicological profile of the substances Undesirable effects and serious undesirable effects Information on the cosmetic product PART B COSM. PRODUCT SAFETY ASSESSMENT Assessment conclusion Labelled warnings and instructions of use Reasoning Assessor s credential and approval of part B

Experiences gained with Regulation 1223/2009 - PIF PRODUCT INFORMATION FILE (PIF) - ARTICLE 11 electronic or other format Source-Graphic : foerderschulekme-moenchengladbach.lvr.de Source -Graphic: imgbuddy.com

Experiences gained with Regulation 1223/2009 - CPSR 11 SPECIFICS FOR THE COSMETIC PRODUCT SAFETY REPORT (CPSR) GUIDELINES ON ANNEX I COMMISSION IMPLEMENTING DECISION of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 on the Cosmetic Product Safety Report (2013/674/EU) Support for understanding individual obligations (e.g. the interaction between Responsible Person and the Safety Assessor) Indepth information on the minimum elements to be considered during a safety assessment (e.g. ingredient characterization, exposure ) Guidelines cannot replace training,! knowledge & expertise of a safety assessor

Experiences gained with Regulation 1223/2009 - CPSR 12 Cosmetics Consultants Europe (C) is an association uniting European consultants & others working in the cosmetic, personal & consumer health care, fine chemical/cosmetic ingredients and borderline industries.

Experiences gained with Regulation 1223/2009 - CPSR 13 CPSR STANDARD CPSR TEMPLATE CPSR TRAINING Summarizing the specifics of the requirements for the CPSR and the individual Safety Assessment Designing a template for the CPSR Develop a training format GOALS

Experiences gained with Regulation 1223/2009 - Claims 14 CRITERIA FOR CLAIMS Regulation (EU) No 655/2013 on Criteria for Claims 1. Legal compliance 2. Truthfulness 3. Evidential support 4. Honesty 5. Fairness 6. Informed decision-making

Experiences gained with Regulation 1223/2009 - Claims 15 CRITERIA FOR CLAIMS 1. LEGAL COMPLIAN (1) Claims that indicate that the product has been authorized or approved by a competent authority within the Union shall not be allowed. (2) The acceptability of a claim shall be based on the perception of the average end user of a cosmetic product, who is reasonably well-informed and reasonably observant and circumspect, taking into account social, cultural and linguistic factors in the market in question. (3) Claims which convey the idea that a product has a specific benefit when this benefit is mere compliance with minimum legal requirements shall not be allowed. Technical document on cosmetic claims (version of 3 July 2017)

Experiences gained with Regulation 1223/2009 - Animal Testing Ban 16 ANIMAL TESTING BAN Since March 2013 the CPR fully prohibits: the performance of animal tests in the EU in order to meet the requirements of the CPR on finished products and on ingredients and combinations of ingredients, the sale of cosmetics products, when the product or the ingredients have been tested on animals - in the EU or outside the EU - in order to meet the requirements of the CPR. THE BAN APPLIES IRRESPECTIVELY OF THE AVAILABILITY OF A TEST ALTERNATIVE

Experiences gained with Regulation 1223/2009 - Animal Testing Ban 17 AVAILABLE VALIDATED ALTERNATIVE METHODS FOR HUMAN SAFETY - 2013 Endpoints Acute toxicity Skin corrosivity Skin irritation Eye irritation Skin sensitization Phototoxicity Toxicokinetics Repeated dose toxicity Reproduction toxicity Mutagenicity/Genotoxicity Carcinogenicity 3Rs Reduction/refinement (oral/inhalation) Full replacement (TG 430, 431) Full replacement (TG 439) Partial replacement 1 (TG 437, 438, 460) No replacement Full replacement (TG 432) No replacement No replacement No replacement Partial replacement 2 No replacement 1 Only for compounds causing "serious eye damage" (category 1 of the GHS), or not requiring classification for eye irritation or serious eye damage according to the GHS. 2 Only for negative results, not possible to follow-up positive/false positive results since animal data would be required. Source: PAmcoff, InCosmetics 2014

Experiences gained with Regulation 1223/2009 - Animal Testing Ban 18 KEY ISSUES WITH IMPACT ON INNOVATION New raw materials cannot be tested comprehensively for their hazards when single use in cosmetics applies. For existing cosmetic ingredients with unique use in cosmetics, limitations appear when SCCS or ECHA require additional animal data, e.g., due to up-coming new concerns.

Experiences gained with Regulation 1223/2009 - Animal Testing Ban 19 STRATEGIES FOR INGREDIENT & PRODUCT MANUFACTURERS > IN-VITRO, IN-SILICO, IN-CHEMICO METHODS Isabel Ramos BIT ADVERSE OUTCOME PATHWAYS Jon Heylings DTI Steven L. Hanft CONUSBAT

Experiences gained with Regulation 1223/2009 - Animal Testing Ban 20 SKIN SENSITIZATION: FIRST CASE OF AN AOP-DRIVEN IATA DEVELOPMENT INTEGRATED APPROACH ON TESTING AND ASSESSMENT (IATA) Source: Isabel Ramos BIT R. Kreiling, InCosmetics 2014 Jon Heylings DTI Steven L. Hanft CONUSBAT

Experiences gained with Regulation 1223/2009 - Animal Testing Ban 21 REGULATORY ACPTAN BY THE SCCS New Approach towards Alternative Methods Page Page Source: Source: Page Source:

Experiences gained with Regulation 1223/2009 - Animal Testing Ban 22 Source: https://eurl-ecvam.jrc.ec.europa.eu/validation-regulatory-acceptance/eurlecvams-validation-process Source: Source: Source:

Regulatory Modules for Cosmetics 23 Horizontal Legislation Isabel Ramos BIT

Horizontal Legislation 24 EU REGULATORY FRAMEWORKS APPLICABLE TO COSMETIC PRODUCTS Regulation (EC) No 1223/2009 on cosmetic products Regulation (EC) No 1383/2003 concerning customs action against goods suspected of infringing certain intellectual property rights Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures Regulation (EC) No 178/2002 laying down the general principles and requirements of food law Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products Regulation (EC) No 440/2008 laying down test methods pursuant to the REACH Regulation

Horizontal Legislation 25 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. Isabel Ramos BIT

Horizontal Legislation - Substance Regulation 26 RESTRICTION

Horizontal Legislation - Substance Regulation 27 RESTRICTIONS FOR USE AS COSMETIC INGREDIENTS DUE TO ENVIRONMENTAL HAZARDS Substance evaluation - CoRAP (Community Rolling Action Plan) If a substance is on this list, it means that a Member State has evaluated or will evaluate it over the coming years. Octocrilene EC / List no.: 228-250-8 CAS no.: 6197-30-4 Suspected PBT/vPvB High (aggregated) tonnage Wide dispersive use

28 SUMMARY The European Union s regulatory framework for cosmetics is Regulation 1223/2009; The regulatory framework applies in full since 2013, following a preceding amendment; The amendment processes adjusted the European Union s framework for cosmetics to a challenging; yet, modern, transparent framework, using various modules for addressing the consumer safety in use of cosmetic products; Horizontal legislation, which is also applicable für cosmetics is identified within the Cosmetics Regulation; Environmental issues of ingredients are addressed under the Isabel Ramos horizontal REACH Regulation. BIT

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