1. General Introduction EU legislation on Cosmetic Product 1223/2009 Dr. Simona Pârvu Ministry of Health Romania TAIEX Workshop on the Introduction of EU Legislation on Cosmetic Products Belgrad, 22-23 of February 2016

2. The European Union Economic and political union of 27 nations (member states) Over 500 million citizens Legal personality Free movement of people, goods, services, and capital

3. The European Union Council of the EU Represents the Government s of MS Presidency is shared on a rotating basis Commission Represents EU interests as a whole Commissio ners appointed by MS Parliament Represents EU citizens Directly elected by citizens

4. EU legislation Regulation Binding legislative act Mandatory in its entirety across the EU Directive sets out a goal that all EU countries must achieve MS decide how Must be transposed to national legislation Decision Binding to whom it is addressed (e.g. a MS or a company)

5. The Single Market in the EU Differences in safety standards in 27 member states are incompatible with free circulation of consumer goods

6. EU Cosmetics Legislation 1976 – 2013 : EU Cosmetics Directive EU Member States have to implement in their own laws (slow and sometimes not perfect) From 2013 : EU Cosmetics Regulation Single piece of legislation instantly and directly enforced across the whole territory of the EU. Increased harmonisation across an EU of 27

7. Objective of the Cosmetics Regulation functioning of the internal market high level of protection of human health Objective = safe products meeting the requirements of the Directive should have equal and immediate access to the market and should be able to circulate freely throughout the European Union.

8. Legislation I EU Regulation no.1223/2009 EU Regulation no.1223/2009 – in force since 11 July 2013 – streamlines the framework for all operators in the sector – protects consumers and makes sure that all cosmetic products on the European market are safe – manufacturers and importers - or the persons responsible for placing the cosmetics products on the market have the main obligation to ensure that their products meet safety requirements – the compliance with the regulations is controlled by the national or regional competent authorities in the EU member states. Relates only to cosmetic products and not to medicinal products, medical devices or biocidal products.

9. Annexes of the Regulation the rules on what may and may not be used as an ingredient, and the rules on restricted use and special precautions, are too detailed to be included here. Annex I - cosmetic product safety report Annexes II and III- banned and restricted substances Annexes IV, V and VI - are positive lists Annex VII: Symbols for Labelling

10. Themost significant changes introduced by the Cosmetics Regulation Strengthened safety requirements for cosmetic products Introduction of the notion of 'responsible person' Centralized notification of all cosmetic products placed on the EU market Introduction of reporting of serious undesirable effects (SUE) New rules for the use of nanomaterials in cosmetic products

11. Layout of the Regulation text Chapter Title Article 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 ANNEXESI-X

12. I. Definition ART. 2 cosmetic product is “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours”. A substance or mixture intended to be ingested, inhaled, injected or implanted into the human body is not a cosmetic product

13. II. Responsible person Only cosmetic products for which a legal or natural person is designated within the EU as "responsible person" can be placed on the market. The new Cosmetics Regulation allows the precise identification of who the responsible person is and clearly outlines the obligations.

14. II. Free circulation of goods The Cosmetics Regulation aims to ensure the free circulation of cosmetic products throughout the EU.free circulation of cosmetic products Member States may not introduce any additional requirements.

15. II. Good manufacturing practice Compliance with GMP is mandatory and needs to be stated by the responsible person; but external certification is not required; Choice of GMP is voluntary : – Compliance is presumed if ISO 22716:2007 is applied – Compliance can also be demonstrated in other ways, e.g. via industry-recognised standards and codes, etc. – Authorities may ask for full GMP documentation, in addition to the statement of compliance

16. III. Product information file Art. 11 Product Information file (a) description of the product (b) cosmetic product safety report (c) description of manufacturing method GMP (d) proof of claim, when relevant (e) data on animal testing

17. III. Safety assessment The persons responsible for placing cosmetic products on the market, to have a safety assessment carried out and ensure the results are available for inspectionsafety assessment The Cosmetics Regulation includes clearer requirements for manufacturers to conduct a safety assessment and produce a product safety report prior to placing a cosmetics product on the market - Annex I Cosmetic products for children under three and cosmetic products intended exclusively for use in external intimate hygiene must undergo a specific safety assessment that takes account of their special needs, for example, their higher skin surface area to body weight ratio. Cosmetic products for children

18. III. Notification ART.13 One centralized notification system at the EC level Managed by the EC Obligation to update For Competent Authorities and Anti- poison Centres

19. Notification II When a product has been notified in the CPNP there is no need for any further notification at national level in the European Union CPNP User Manuals referring to Article 13 (3 MB) referring to Article 16 (337 kB) http://ec.europa.eu/consumers/consumers_safety/cosmetic s/cosmetic_products_notification_portal_cpnp/index_en.ht m

20. IV. Principle of substance regulation Arises from principle of “Responsible Person” and authorities’ in-market control The choice of safe ingredients is in the responsibility of the responsible person (and his safety assessor). For some classes of substances, however, the legislator has identified/maintained the need to introduce EU-harmonised restrictions - Annexes of Cos. Reg.

21. REGULATION (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures Substances or mixtures ar classfied as: 1. respiratory sensitisation, category 1 (Annex I, section 3.4); 2. germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5); 3. carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6); 4. reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7 All CMR (carcinogenic, mutagenic or toxic for reproduction) are banned when their chemical hazard classification becomes applicable. Exemptions can be granted for all CMRs – based on certain conditions Bans are automatic - exemptions need implementing act under the Cosmetics Regulation  Exemption must be completed before the automatic ban enters into force !

22. V. Rules on animal testing ART. 18 The Regulation also restricts the supply of cosmetic products whose final formulation, or any ingredient or combination of ingredients, have been tested on animals. It is an offence to test a finished cosmetic product or on an ingredient on an animal in order that the product may comply with the requirements of the Regulation. Where a claim is made that a cosmetic product has not been tested on animals, this must be correct.

23. VI. Information to consumers Labelling ART. 19 – All required information must be visible, indelible and easily legible. – All of the other information must be in the national language and can be supplemented by other languages. Claims art. 20 – Basic requirements for non-misleading claims and proof of effect in PIF

24. VII. In-market surveillance ART. 22 The Cosmetics Regulation requires the national governments of EU Member States to have surveillance systems that monitor compliance with all requirements An official body in each country carries out in-market control inspections. These bodies have powers to analyse samples for compliance with requirements for labelling, ingredients and microbiological quality.official body in each country

25. VII. Communication of serious undesirable effects (SUE) Art. 23 Definition of (serious) undesirable effects Obligation for RP and distributors to report to authorities : (a) all serious undesirable effects which are known to him or which may reasonably be expected to be known to him; (b) the name of the cosmetic product concerned, enabling its specific identification; (c) the corrective measures taken by him, if any.

26. IX. Housekeeping and good administrative practice Member States must require corrective measures or market withdrawal in case of non-compliance. Measure must be proportionate to the risk. In case of serious risk, the RAPEX information network is used. In case of serious risk, member states are allowed to take unilateral action– subject to subsequent review at EU level. Member States must allow the responsible person to offer his viewpoint.

27. Changes to the Cosmetics Regulation Amendments Commission Regulation (EU) No 1004/2014 of 18 September 2014 amending Annex V to Regulation Amendments to the Cosmetics Regulation Commission Regulation (EU) No 1004/2014Amendments to the Cosmetics Regulation Commission Regulation (EU) 2015/1298 of 28 July 2015 amending Annexes II and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (3-Benzylidene Camphor) Commission Regulation (EU) 2015/1298 of 28 July 2015 amending Annexes II and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (3-Benzylidene Camphor) Commission Regulation (EU) 2015/1190 of 20 July 2015 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (hair dyes) Commission Regulation (EU) 2015/1190 of 20 July 2015 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (hair dyes) Commission Regulation (EU) No 1004/2014 of 18 September 2014 amending Annex Ⅴ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Parabens) Commission Regulation (EU) No 1004/2014 of 18 September 2014 amending Annex Ⅴ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Parabens) Commission Regulation (EU) No 1003/2014 of 18 September 2014 amending Annex Ⅴ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (MCI-MI) Commission Regulation (EU) No 1003/2014 of 18 September 2014 amending Annex Ⅴ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (MCI-MI) Corrigendum to Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes Ⅲ, Ⅴ and Ⅵ to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (alkyl (C16, C18, C22) trimethylammonium chloride, citric acid (and) silver citrate, ETH-50 (nano)) Corrigendum to Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes Ⅲ, Ⅴ and Ⅵ to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (alkyl (C16, C18, C22) trimethylammonium chloride, citric acid (and) silver citrate, ETH-50 (nano)) Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes Ⅲ, Ⅴ and Ⅵ to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (alkyl (C16, C18, C22) trimethylammonium chloride, citric acid (and) silver citrate, ETH-50 (nano)) Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes Ⅲ, Ⅴ and Ⅵ to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (alkyl (C16, C18, C22) trimethylammonium chloride, citric acid (and) silver citrate, ETH-50 (nano)) Commission Regulation (EU) No 358/2014 of 9 April 2014 amending annexes Ⅱ and Ⅴ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (parabens & triclosan) Commission Regulation (EU) No 358/2014 of 9 April 2014 amending annexes Ⅱ and Ⅴ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (parabens & triclosan) Commission Regulation (EU) No 1197/2013 of 25 November 2013 amending Annex Ⅲ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (hair and eyelash dyes) Commission Regulation (EU) No 1197/2013 of 25 November 2013 amending Annex Ⅲ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (hair and eyelash dyes) Commission Regulation (EU) No 658/2013 of 10 July 2013 amending Annexes Ⅱ and Ⅲ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (hair dye products) Commission Regulation (EU) No 658/2013 of 10 July 2013 amending Annexes Ⅱ and Ⅲ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (hair dye products) Commission Regulation (EU) No 483/2013 of 24 May 2013 amending Annex Ⅲ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Polidocanol) Commission Regulation (EU) No 483/2013 of 24 May 2013 amending Annex Ⅲ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Polidocanol) Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes Ⅱ, Ⅲ, Ⅴ and Ⅵ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes Ⅱ, Ⅲ, Ⅴ and Ⅵ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products Commission Regulation (EU) 2015/1298 of 28 July 2015 amending Annexes II and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (3-Benzylidene Camphor) Commission Regulation (EU) 2015/1298 of 28 July 2015 amending Annexes II and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (3-Benzylidene Camphor)

28. The Scientific Committee for Consumer Safety (SCCS)Scientific Committee for Consumer Safety evaluates substances that are, or could be used in cosmetics. It is the scientific advisory body to the European Commission and no substance can be regulated without its opinion.

29. Committees – Standing Committee on Cosmetic Products (Member States) – Working Group on Cosmetics (Member States + Industry, Consumers’ Groups and Animal Protection Groups  transparency)

30. Legislation III Commission Implementing Decision 2013/674/EUof 25 November 2013 in Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliement and of the Council on cosmetic products (Guidelines on the Cosmetic Products Safety Report) Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products Guidelines to Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products SUE REPORTING GUIDELINES

31. IMPORTANT http://ec.europa.eu/growth/sectors/cosmetics/ http://ec.europa.eu/growth/sectors/cosmetics/legislation /index_en.htm http://eur-lex.europa.eu/legal- content/en/ALL/?uri=CELEX%3A32009R1223

32. Thank you for your attention !