1. Responsible person, Distributors Responsibilities & Obligations Non-compliance Irina T ă nase Toxicologist - National Institute of Public Health, Romania TAIEX Workshop on the Introduction of EU Legislation on Cosmetic Products February, 22-23, 2016

2. Agenda Main actors of CPR Who is the Responsible Person? Main obligations of – Responsible Person – Distributors Examples of non-compliance Quiz

3. Main actors of CPR (1) Manufacturer Importer Distributor End user Authority

4. Main actors of CPR (2) MANUFACTURER 1.natural or legal person 2.manufactures a cosmetic product, or has such a product designed or manufactured, 3.markets that cosmetic product under his name or trademark."

5. Main actors of CPR (3) IMPORTER 1.natural or legal person 2.established within the Community, 3.places a cosmetic product from a third country on the Community market.

6. Main actors of CPR (4) DISTRIBUTOR 1.natural or legal person in the supply chain, 2.other than the manufacturer or the importer 3.makes available a cosmetic product on the Community market

7. Main roles in CPR (1) RESPONSIBLE PERSON (RP) a single person responsible for ensuring compliance with the cosmetic legislation 1 cosmetic = 1 responsible person=1 address of cosmetic file; ‘Place on the market’ -the first making available …on Community market” (Art 2(h))

8. Main roles in CPR (2) DISTRIBUTOR 1 cosmetic = “n” distributors ‘Make available’ - any supply … for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge” (Art.2(g))

9. Who can act as RP ? (1) Who can act as RP ? (1) Cosmetic product manufactured within the EU, not subsequently exported and imported back in the EU Manufacturer established within the EU: - shall be the RP, (automatically attributed) or -may designate by written mandate, a person established within the EU (result from a contract) Manufacturer established outside the EU: - must designate by writtenmandate, a person established within the EU (result from a contract)

10. Who can act as RP ? (2) IMPORTER - shall be the RP, (automatically attributed), or - may designate by written mandate, a person established within the EU (result from a contract); DISTRIBUTOR shall be the RP if: - places on the market a cosmetic product under his name or trademark (automatically attributed); - modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected (automatically attributed)

11. Obligations of RP (1) Safety Art.3 Safety assessment Art.10 Claims Art.20 Labelling Art.19 (1) (2) (5) Notification Art.13 Undesirable Effects Art.23 Traces of prohibited substances Art.17 Sampling and analysis Art.12

12. Obligations of RP (2) Information on substances Art.24 PIF Art.11 Nanomaterials Art16 GMP Art8 Access to information for the public Art21 CMR Art15 Animal testing Art18 Restrictions for substances listed in the Annexes Art14 Supply chain Art7

13. Obligations of distributors (1) Shall act with due care in relation to applicable requirements TO VERIFY: — the labelling information (Art.6.(2): the name or registered name and the address of the RP the batch number of manufacture the list of ingredients — the language requirements (Art.6.(2): — the date of minimum durability (Art.6.(2):

14. Obligations of distributors (2) To inform the RP and the competent national authorities in case of a risk to human health (Art.6(3); not to make available on the market and apply corrective measures to bring that product into conformity(Art.6(3); To ensure appropriate storage or transport conditions(Art.6(4) shall cooperate with competent authorities (Art.6(5)

15. Obligations of distributors (3) To identify RP or other distributors within the supply chain (Art.6(3); To notify on CPNP a product having a label translated by own initiative in order to comply with national law (Art.13(3); To communicate about the serious undesirable effects (SUE) (Art.23(1)(3)

16. Safety of the product Responsible person: to perform the safety evaluation of his products or to have such evaluation made on his behalf The safety of cosmetics must be assessed prior to marketing To taking account of presentation including, conformity with Directive 87/357/EEC (Food imitating products)

17. Safety of the product Distributors: To record in-market experience with the cosmetic products they sell; To verify the conformity of the labelling; To ensure the safe handling and storage To cooperate with Member States’ authorities.

18. Good Manufacturing Practice Responsible person: to demonstrate compliance by including a statement in the PIF (CPR does not require external certification to be obtained); – Compliance will be presumed if GMP is in accordance with an established harmonized standard published in the OJEU – harmonized standard = standard adopted by one of the European standardization bodies listed in Annex I to Directive 98/34/EC. (Art. 2(1)(j) – CEN ISO 22716

19. Safety assessment (SA) Responsible person : To ensure that SA has been performed by a safety assessor; To follow all the recommendations of the safety assessor (including to reject, or to accept under specific conditions the formulation) – the liability concerning the safety assessment of the product is shared between the Responsible Person and the Safety Assessor

20. Product Information File-PIF Responsible person : To keep a PIF for each product placed on the market To make PIF readily accessible to the competent authority of the MS in which the file is kept; To kept for an additional period of ten years following the date on which the last batch was placed on the market To indicate the PIF address on the label; To ensure that PIF is up-dated To make available in a language which can be easily understood by the competent authorities

21. Sampling and analysis Responsible person : To ensure compliance with sampling and analysis: – sampling and analysis should be carried out in a reproducible and standardised manner standardised – in accordance with the relevant harmonised standards

22. Notification To submit the information (related to the product), prior to placing the cosmetic product on the market. Cosmetic Products Notification Portal Art. 13(1) – Notification by the Responsible Person Article 13(3) – Notification by the Distributor

23. Restrictions for certain substances (1) Responsible person To check that: No prohibited substances listed in the Annex II are used No restricted substances are above the allowed limit (Annex III column (g) are used; The label are in compliance with the provisions of Annex III column (i); “Wording of conditions of use and warnings”

24. Restrictions for certain substances (2) Responsible person Have to check that: colourants listed in Annex IV; Preservatives listed in Annex V ; UV-filters listed in Annex VI ; are used in accordance with the corresponding conditions laid down in CPR Annexes

25. Substances classified as CMR Responsible person To make no available on the market a cosmetic product containing a substance which is classified as a CMR substance, under Part 3 of Annex VI to the Regulation (EC) No 1272/2008 (CLP Regulation), of : category 2, or category 1A or 1B, unless there are met the conditions specified in Article 15(2) of CPR

26. Nanomaterials Responsible person To notify on CPNP the cosmetic products that contain nanomaterials, six months prior to their placing in the market (Art.13), except: – Ingredients listed specifically in their nano form in the Annexes IV, V and VI – nanomaterials, which meet the requirements set in the Annex III; To label of all nanomaterials in the list of ingredients

27. Traces of prohibited substances Responsible person shall be kept to a minimum, especially by putting in place and applying the “As Low As Reasonably Acceptable” (ALARA) principle To identify and to assess an unwanted trace substance To justify and to give a proof of "technically unavoidable" prohibited substances

28. Animal testing Responsible person: To ban on testing of finished cosmetic ingredients or combinations of ingredients To include in the PIF the data on any animal testing performed by the manufacturer, agents or suppliers and performed to meet the regulatory requirements of third countries or a statement indicating that no animal testing has been conducted

29. Labelling (1) Responsible person To ensure compliance with labelling requirements. To include all particular precautions decided to be labeled by the safety assessor To comply with language requirements.

30. Labelling (2) Distributors To check the packaging of the products To verify that specific information is present on the label, To verify whether certain information is in the language required under the applicable national law

31. Claim Responsible person In relation with Commission Regulation (EU) No 655/2013: -To build the claim (or consumer message) -To provide sufficient evidence to substantiate reasonable consumer expectations of that claim; -To ensure the quality of tests supporting the claim

32. Access to information for the public Responsible person To ensure the public access to: qualitative and quantitative composition in hazardous substances, according to Art. 3 of Regulation (EC) No 1272/2008 (CLP) the name and code number, the identity of the supplier of perfume and aromatic compositions existing data on undesirable effects and serious undesirable effects

33. Communication of serious undesirable effects (SUE) Responsible person To ensure that he/she or the distributors shall notify SUE without delay to competent authority of MS involved; For this purpose: – (1) To verify the existence of the UE and the conditions under which the product was used (misuse or not). – (2) To verify the level of causality between the product and the UE (i.e. assessment of whether the adverse effect can be attributed to the use of the product – (3) To determine the seriousness of the UE

34. Information on substances, regarding the safety Responsible person To provide information upon a competent authority in the case of : reasoned request from an authority (art. 5(3) Serious doubt regarding the safety of a substance contained in cosmetic products (art. 24)

35. General obligations of distributors to demonstrate the conformity of the products upon request by an authority (Art.6(5) e.g.: copy of the labels when the authority requests proof of labelling compliance to take appropriate measures in case of non-conformity of a product. (art.26)

36. Examples of non-compliance (distributor, label translation ) Original label“Translated” label The product suits to all skin types, but it is particularly good for dry and sensitive skin that need moisture. Used regularly they help restore the skin's smoothness, softness and flexibility by helping the skin retain moisture. It should be applied once a day, particularly after washing, to prevent the skin drying out. The product suits to all skin types, but it is particularly good for dry and sensitive skin of adults and babies, that need moisture. The cream is helpful for all dry skin conditions, particularly eczema and dermatitis. Used regularly they help restore the skin's smoothness, softness and flexibility by helping the skin retain moisture. It should be applied twice a day, particularly after washing, to prevent the skin drying out. Non-compliance: Different Safety assessment (introducing babies and other frequency of use), not cosmetic (prevent conditions, like eczema) and copyright violation (the content of label is the property of manufacturer)

37. Examples of non-compliance responsible person -Food-imitating product RAPEX notifications Non-compliance with Art. 3 of CPR

38. Non-compliance, responsible person and distributors, claim substantiation and safety Sun protection claim (SPF15); no UV filters included in formula Non-compliance with art. 20 and art. 3 of CPR RAPEX.notification

39. Non-compliance, responsible person, use of prohibited substances listed in Annex II of CPR Use of clobetasol propionate listed in the Annex II, entry 300 Non compliance with art. 14 of CPR RAPEX notification

40. Non-compliance, responsible person, use of CMR substances The product contain ketoconazole 2%– reprotoxic 1B Non-compliance with Art.15 of CPR

41. Quiz… A company manufactures cosmetic products for different customers. Who is RP? Each one of the customers selling cosmetic products under their own name or brand is RP Two companies imported the same product manufactured outside EU by the same manufacturer. Who must to be RP? Both of them. Art. 4(5) establishes that for an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market.