Responsible Person v. Safety Assessor Sylvie Gallage-Alwis Avocat à la Cour / Solicitor in England & Wales ECORE ERPA Seminar – Tel Aviv – 16 June 2014

Overview Regulation 1223/2009 dated 30 November 2009 – fully into force since 11 July 2013 Responsible person: "Only cosmetic products for which a legal or natural person is designated within the Community as 'responsible person' shall be placed on the market" (Art. 4) Safety assessor:  "In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment" (Art. 10)  "a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State" (Art. 10) 2

Responsible Person v. Safety Assessor 1.2 key players for 1 top priority in the EU: the protection of the consumers 2.The definition of the Responsible Person and the Safety Assessor 3.The Roles of the Responsible Person and the Safety Assessor 4.The liabilities and risks that may be faced by the Responsible Person and the Safety Assessor 5.The diverging interests of the Responsible Person and the Safety Assessor 6.The need for cooperation 3

1. Top priority in the EU : protection of the consumers Regulation 1223/ Article 1: "This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health". 2 key players : the Responsible Person the Safety Assessor 4

2. Definition of the Responsible Person and the Safety Assessor Safety Assessor Article 10 of Regulation 1223/2009 "person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State" 5 Responsible Person (RP) Article 4 of Regulation 1223/2009 Cosmetic product manufactured within the EU, by a manufacturer established within the EU, not subsequently exported and imported back in the EU : -The manufacturer shall be the RP -The manufacturer may designate by written mandate, a person established within the EU Imported cosmetic products : -Each importer shall be the RP of the product he places on the market -The importer may designate by written mandate, a person established within the EU Cosmetic product manufactured within the EU, by a manufacturer established outside the EU, not subsequently exported and imported back in the EU : -The manufacturer must designate by written mandate, a person established within the EU Cosmetic product placed on the market under the distributor's name or trademark or product already placed on the market modified by the distributor in such a way that compliance with the applicable requirements may be affected : -The distributor shall be the RP 4 cases

3. Roles of the Responsible Person and the Safety Assessor 6 The Responsible Person: Ensures compliance of the product with the rules set out in the Regulation relating to:  Human health  Safety  Consumer information Maintains a product information file accessible to the public authorities Ensures product traceability by identifying the distributors to whom they supply the cosmetic product for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor (the same applies to all other persons involved in the supply chain) In case of non-compliance with the Regulation, takes corrective measures, withdraws the product or recalls it Informs the authorities if the product presents a risk to human health The Safety Assessor: Carries out the cosmetic product safety assessment, as set out in Part B of Annex I of Regulation 1223/2009

List of the obligations of the Responsible Person Safety (article 3) Good manufacturing practices (article 8) Safety assessment (article 10) Product information file (article 11) Sampling and analysis (article 12) Notification (article 13) Restrictions for substances listed in the Annexes (article 14) CMR (article 15) Nanomaterials (article 16) Traces of prohibited substances (article 17) Animal testing (article 18) Labelling (article 19) Product claims (article 20) Access to information for the public (article 21) Communication of serious undesirable effects (article 23) Information on substances (article 24) 7

How do they both contribute to the protection of consumers? 8 Ensures safety of the product Ensures market surveillance Ensures transparency Ensures cooperation with the Authorities The Responsible Person Ensures safety of the product The Safety Assessor

4. Liabilities 9 Principle of liability of the Responsible Person Safety Assessor's unique expertise Share of liability between the Responsible Person and the Safety Assessor concerning the safety of the product

10 What are the risks? If the product does not comply with the Regulation or the good manufacturing practices → even if no safety risk If the product presents a safety risk Sanctions to be established by each Member State Civil liability Contractual liability Criminal liability

11 Article 10 of Regulation 1223/2009 Responsible Person is liable for Annex I Part A (Cosmetic Product Safety Report) 1.Quantitative and qualitative composition of the cosmetic product 2.Physical/chemical characteristics and stability of the cosmetic product 3.Microbiological quality 4.Impurities, traces, information about the packaging material 5.Normal and reasonably foreseeable use 6.Exposure to the cosmetic product 7.Exposure to the substances 8.Toxicological profile of the substances 9.Undesirable effects and serious undesirable effects 10.Information on the cosmetic product Safety Assessor is liable for Annex I Part B (Cosmetic Product Safety Assessment) 1.Assessment conclusion 2.Labelled warnings and instructions of use 3.Reasoning 4.Assessor's credentials and approval of part B Result type of obligation → as soon as there is a non- compliance, liability is incurred Best efforts type of obligation → the liability will be incurred if it is shown that not all the reasonably expected and necessary steps were taken

5. The diverging interests of the Responsible Person and the Safety Assessor 12 Safety Assessor Make sure it has all the appropriate data to carry out its mission Have its liability limited in case of non-compliance Be sure that the product will not change after its assessment Responsible Person Be 200% sure that the product is compliant with the Regulation Have all data necessary to be sure and answer the authorities Have its liability limited in case of non-compliance

13 Diverging interests = diverging clauses Responsible Person Limitation of liability clause Definition of the obligations of the Safety Assessor Involvement of the Safety Assessor in case of control/claim Information of the Safety Assessor in case it looses its diploma or has its liability at stake for another product Safety Assessor Detailed description of the assessed product Limitation of liability clause Definition of the information to be provided by the Responsible Person Amendment of the contract in case of further tests to be carried out Obligation of the Responsible Person to inform on any change in the product/formula

6. Cooperation between the Responsible Person and the Safety Assessor Diverging interests should not lead to a lack of cooperation Cooperation is needed:  to set up the cosmetic product safety report "Where the responsible person drawing up the cosmetic product safety report is not the manufacturer of the product, they should ensure they have access to all the technical and scientific skills necessary to obtain reliable cosmetic product safety information and an appropriate safety assessment to demonstrate that the product they are responsible for is safe […]. They may therefore need to involve […] the safety assessor" (Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products)  to ensure that the safety of the product is properly assessed "The responsible person and the safety assessor should work closely together to ensure that the safety of the product is properly assessed and documented and that the assessment is kept up to date. The responsible person and the safety assessor should gather all the necessary information as required by Part A of Annex I to Regulation (EC) No 1223/2009" (Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products) 14

Cooperation between the Safety Assessor and the Responsible Person  to ensure that the Safety Assessor has all the data needed for the safety assessment of the product "Part A of the cosmetic product safety report is intended to gather the data necessary to prove that the cosmetic product is safe. The information should enable the safety assessor to clearly identify and quantify, based on the identified hazards, the risks a cosmetic product may present to human health". "The responsible person, may consider that, depending on the type of product, some of the required data are not relevant or necessary to assess the safety of the product (e.g. preservation challenge test). In this case, the absence of specific data is to be clearly justified in Part A and the justification is to be repeated and validated by the safety assessor in their reasoning in Part B. The responsible person should check the presence of the required data or the justification for their absence". (Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products) 15

Questions 16 Contact: Sylvie Gallage-Alwis

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