Dr. Matteo Zanotti Russo

Transcription

1 Dr. Matteo Zanotti Russo Angel Consulting - Italy CRCC Berlin, October 2017

2 What s on EU Commission Report on product claims Are we complying with EU Regulation no. 655/2013 What are Authorities inspecting? 2

3 Definition: what exactly is a claim? Definition is missing in 1223/2009 Report From the Commission to the European Parliament and the Council (Brussels, COM(2016) 580 final it is very important to provide consumers with specific, understandable and reliable information, substantiated using generally accepted methods, to enable them to make informed choices and compare products to find the ones that best suit their needs. 3

4 Purpose Describes explicitly and implicitly the product s function, content & effects Helps the targeted audience differentiate between different products Stimulates innovation & competition on the market 1223/2009/EC art. 20 shall not be used to imply that these products [which were established to be cosmetics] have characteristics or functions which they do not have (art. 20.1) 4

5 1223/2009 EC 655/2013 EC: Common Criteria for the justification of Claims used in relation to cosmetic products legal compliance, truthfulness, evidential support, honesty, fairness informed-decision making Guidelines to Commission Regulation (EU) No 655/2013 Annexes and Examples 5

6 1223/2009 EC, Introduction: (51) The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products. In particular Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (1) is applicable. Furthermore, the Commission, in cooperation with Member States, should define common criteria in relation to specific claims for cosmetic products. Art. 11, Product Information File: (e) where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product; 6

7 Art. 20: Product claims 1. In the labelling, making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have. 2. The Commission shall, in cooperation with Member States, establish an action plan regarding claims used and fix priorities for determining common criteria justifying the use of a claim. 7

8 Art. 20: Product claims After consulting the SCCS or other relevant authorities, the Commission shall adopt a list of common criteria for claims which may be used in respect of cosmetic products, in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation, taking into account the provisions of Directive 2005/29/EC. By 11 July 2016, the Commission shall submit to the European Parliament and the Council a report regarding the use of claims on the basis of the common criteria adopted under the second subparagraph. If the report concludes that claims used in respect of cosmetic products are not in conformity with the common criteria, the Commission shall take appropriate measures to ensure compliance in cooperation with the Member States. 8

9 : Report from the Commission to the European Parliament and the Council on products claims based on common criteria in the field of cosmetics Introduction: Description of EU Cosmetic Business Market Size: 77 Billions 25% new products each year 1/3 exported About 1 Million of different kind of cosmetics in the market 9

10 Directive 2005/29/EC on business-to-consumer unfair commercial practices and 1223/2009 art. 20 similar object Regulation 1223/2009 prevails as lex specialis 2012: Cosmetics Europe developed Charter and Guiding Principles on Responsible Advertising and Marketing Communications (C&GPs) 2015: EASA (European Advertising Standards Alliance, Self Regulation Body) first monitoring of 1861 advertisements 91% of compliance 10

11 What is a SRO/SRB? Self Regulation Organization/Body Commission s Better Regulation Package self-regulatory tools important and complementary to regulatory tools ( ): EASA: European Advertising Standard Alliance 11

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13 Promotes responsible advertising in commercial communications by means of effective self-regulation Non-profit organisation based in Brussels which was founded in 1992 to facilitate advertising standards across a growing Single Market EASA has a network of 41 organisations representing 27 advertising standards bodies (also called self-regulatory organisations) from Europe and 14 organisations representing the advertising ecosystem (the advertisers, agencies and the media). 13

14 Member States Market Surveillance (21 members), July December 2015 Claims checked: claims characterising ingredients (e.g. anti-ageing ); claims related to the product s efficacy (e.g. a skin cream with a sun protection factor); claims highlighting the absence of substances (e.g. free from perfume ); claims addressing skin compatibility of the product (e.g. hypoallergenic, for sensitive or atopic skin ); claims addressing health or additional benefits other than the cosmetic purpose (e.g. sunscreens or intimate hygiene products). 14

15 Member States analysis of Claims on: PIFs Documents Analysis on samples (mainly for products that claimed the presence or the absence of substances) Results: on cosmetic products 90% of compliant products Criticalities 15

16 In some Member States, up to 70 % of non-compliant claims were found online, only 17 % were found on the actual product, and 13 % were found in brochures Product performance 16 out of the 21 Member States that replied stated that they found cases where evidential support and honesty criteria were breached in products claiming a function that could not be supported with sufficient evidence, with the available studies lacking reproducibility and scientific strength. 16

17 Medicinal properties, claims of treatment ability and therapeutic effects 10 Member States found claims stating a cosmetic product s medicinal effect, breaching a number of criteria such as, informed-decision making, honesty, evidential support and legal compliance. They highlighted increased difficulties to distinguish and classify borderline products, i.e. whether a product is a cosmetic or a medicine or a medical device. 17

18 Free from authorised ingredients 10 Member States raised the issue of the fairness criterion being breached in the claims checked because of the denigration of authorised ingredients. Such claims include for instance free from parabens or free from aluminium. 18

19 Free from banned ingredients Some Member States notified that cases of claims highlighting the absence of prohibited ingredients and claims mentioning the respect of EU quality standards and good manufacturing practices were considered noncompliant, breaching the legal compliance criterion Hypoallergenic claims 7 Member States reported cases of hypoallergenic claims without supporting documents or evidence. 19

20 Claims on the presence/absence of ingredients although they were not found/found in the product 5 Member States reported cases of absence of ingredients mentioned in a product claim, which breaches the truthfulness criterion. 20

21 Not tested on animals and the rabbit logo 4 Member States found cases of non-compliance with the evidential support criterion when, although products were claiming to be not tested on animals through the presence of the rabbit logo or text, the responsible person did not have evidence of this for all the cosmetic components. 21

22 Written advice to the responsible person, importer or manufacturer, ordering and prohibiting sales until the product complies with the requirements. Request to the responsible person to modify the claim in the advertisement not only on the product but also in the media and on the internet. Order for the responsible person to retroactively carry out skin-compatibility tests for a specific target group. Instruction to the responsible person to conduct new studies to get enough evidence to retroactively support the claims. Financial sanctions imposed in some Member States. Ensuring that the labelling is corrected through repeated market surveillance actions or the reception of relevant documentary evidence before accepting the products back on the market. 22

23 Conclusion: The existing European regulatory framework for claims and advertising of cosmetic products is very comprehensive and ensures a high level of consumer protection. At the same time, it enables the European cosmetics industry to be competitive within the EU and in the world. 23

24 The structure: Body, Annex I: Common Criteria (with examples), Annex II: Best Practice for claim substantiation evidence Implemented with Annex III: Free From claims Annex IV: Hypoallergenic claims 24

25 Technical Document on Cosmetic Claims Agreed by the Sub-Working Group on Claims (version of 3 July 2017) 25

26 Legal compliance The claim 'free from Corticosteroids' is not allowed, as Corticosteroids are banned by EU cosmetics legislation. Truthfulness The claim 'free from Formaldehyde' is not allowed, if the product contains a formaldehyde releasing ingredient (e.g. Diazolidinyl Urea). Evidential support The absence of (a) specific ingredient(s) should be demonstrated by adequate and verifiable evidence. See Annex II 26

27 Honesty The claim 'free from allergenic/sensitizing substances' is not allowed. A complete absence of the risk of an allergic reaction cannot be guaranteed and the product should not give the impression that it does. Fairness Certain parabens are safe when used in accordance to Regulation (EC) No 1223/2009. Considering the fact that all cosmetic products must be safe, the claim 'free from parabens' should not be accepted, because it is denigrating the entire group of parabens. 27

28 Informed decision-making The following claims should be permitted if they also comply with the other common criteria: 'free from alcohol', e.g. in a mouthwash intended as a family product; 'free from animal-derived ingredients', e.g. in products intended for vegans; or 'free from acetone', e.g. in nail polish, for users wishing to avoid its particular smell. 28

29 The presence of known allergens or allergen precursors should be totally avoided, in particular of substances or mixtures: identified as sensitizers by the SCCS or former committees assessing the safety of cosmetic ingredients; identified as skin sensitizers by other official risk assessment committees (CLP Regulation 1272/2008) identified by the company on the basis of the assessment of consumer complaints; generally recognized as sensitizers in scientific literature; or for which relevant data on their sensitizing potential are missing. 29

30 National authority (survey or customer complaint) (governative agency for the fair trade and, commonly in charge for the 2005/19/EC, business-to-customer) SRO (EASA members) Warning to the company: comparison, substantiation support The Advertiser can demonstrate the substantiation Negotiation for modifying claims Local SRO can forward to their National Authority PENALTY 30

31 Claims Compliance is never given by a check list (wrong aproach) Several issues at the same time (visual, presentation, descriptions, customer-target) Testing/analysis/support has to be armonized with marketing aim and scientific support Multitasking! 31

32 Be sure about the claim efficacy! The focus has to be how to demonstrate, not wondering if it works Check compliance with the cosmetic product definition & borderline guidelines Refine claims! Check the balance between the strenght of the claim and the substantiated data Soften the claim in case of weak substantiation and avoid (as general rule) the promise of spectacular effect in a very short time 32

33 Set up a testing strategy that can proof the claim Claim/testing/advertising has to be led under regulatory+legal+clinical supervision Involves the RP & SA! Check and keep updated EU Guidelines (look the examples) In case of doubt ask pre-evaluation to national SRO, member of EASA 33

34 Conclusions Multitasking Scientific support Communication strategy Common Criteria 34

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36 Thank You for Your Attention! 36