Natural Cosmetics and EU Claims Legislation

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1 NATRUE Assembly Meeting Berlin, Germany, June 1st 2016 CALLAGHAN CONSULTING INTERNATIONAL Natural Cosmetics and EU Claims Legislation Compliance, Issues and Future Perspectives Dr. Theresa Callaghan Callaghan Consulting International

2 All challenges are opportunities in disguise, and attempting to predict future trends in a category that has experienced tremendous innovation over the last two decades is both challenging and opportunistic. Created in 2008, CCI is an R&D business consultancy for the dermatology sector including cosmetics. We provide a bespoke service in skin science product development and EU cosmetics claims legislation advice. Skin Complexities Business & Technology Development Claims Development & Testing Design RP Support for Claims Communications - tmc@ccintl.eu Dr. Theresa M. Callaghan has served more than 27 years in international senior director and management positions of the global skin care industry, including Unilever, Marks & Spencer, Johnson & Johnson, Evonik, Hill Top Research, and proderm. YOUR INDEPENDENT CONSULTANT PARTNER IN DERMATOLOGY FOR SCIENTIFIC & EU COSMETIC CLAIMS LEGISLATION ADVICE

3 Introduction Are your natural/ organic beauty products honest when it comes to claims? Lack of Evidence Vagueness Irrelevant Not Truthful False Labelling

4 Its the Law! Legal, Fair, Truthful, Honest, Evidence, Informed Decision-Understandable, Safe EC/1223/09 Article 20 and the Claims Criteria Legislation under (EU) No 655/2013. 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. Which means DO NOT TELL LIES!

5 Integrity & Relevance of NOC s Legal, Fair, Truthful, Honest, Evidence, Informed Decision-Understandable, Safe The acceptability of a claim shall be based on the perception of the average end user - Legality No false or irrelevant information. Truthful Ingredient claims shall not imply that the finished product has the same properties when it does not - Truthful Presentations of a product s performance shall not go beyond the available supporting evidence - Honesty Claims for cosmetic products shall be objective and shall not denigrate the competitors, nor shall they denigrate ingredients legally used - Fairness Marketing communications shall take into account the capacity of the target audience. to comprehend the communication shall be clear, precise, relevant and understandable! - Informed Decision

6 Evidence.evidence or substantiation SHALL BE CONSISTENT WITH THE TYPE OF CLAIM BEING MADE. Statements of clear exaggeration (hyperbole) or statements of an abstract nature shall not require substantiation. A claim EXTRAPOLATING (explicitly or implicitly) ingredient properties to the finished product SHALL BE SUPPORTED BY ADEQUATE AND VERIFIABLE EVIDENCE... Assessment of the acceptability of a claim shall be based on THE WEIGHT OF EVIDENCE* OF ALL studies, data and information available depending on the nature of the claim AND THE PREVAILING GENERAL KNOWLEDGE BY THE END USERS.

7 Claims Criteria The criteria of this legislation cannot be viewed nor taken in isolation: Claims cannot be considered Legal unless they are Truthful. Truthfulness requires Evidence. Evidence needs to be Honest. Honesty requires Fairness which itself provides for Informed Decision Making - and ultimately a satisfied consumer.

8 Issues Brands want to make drug-like claims. Brands want to continue to extrapolate data into claims. Brands want to copy-paste into claims. In EU allowed to say that a cosmetic is a product intended to exert a physical, and not a physiological, effect on the human body. Wording and Intended-Use are important for EU. Industry needs to become more serious about claims - big marketing opportunity! 8

9 Extrapolation of Ingredient Properties Guidelines to (EU) No 655/2013: The claim contains moisturising aloe vera or prominently picturing aloe vera shall not be made if the product itself has no moisturising effect. Why? The efficacy of a cosmetic formulation is a product of the interactions between active ingredients and the structural formula. Physical stability vs. Bio-stability Need to know: bioavailability, biochemical and physiological stability. In the absence of product testing,., may not extrapolate testing results on a particular product ingredient contained in its product to substantiate performance claims for its product when it contains other ingredients that could impact upon product performance. (USA Regs.).

10 What Are Your Objectives? What is your concept/claim ideas? What body site - hands, feet, face etc. What is it you want to measure? What weight of evidence do you need to build your claim(s)?.requires ROBUST documentation of Evidence - CAP, ASA, Cosm.Eur.

11 Objectives: Claims/Concepts Ingredient Performance Lifestyle Sensory/Aesthetic Endorsement Negative Fluffy Photographic 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.

12 Objectives: Body Site

13 Objectives: Measurements e.g. Moisturisation Hydration Barrier function & repair Emolliency Skin feel - firmness, smoothness, glow etc. Dry itch Dry flake Dry redness > Laboratory Research Corneometer TEWL Aquaflux Raman Spectroscopy Digital photography Colorimeter Derm. evaluation Consumer use Etc. Etc.

14 Objectives: Body of Evidence for Building Moisturisation Claims Scientific literature - peer reviewed Patents Expert opinion Supplier data* Laboratory Studies* Studies on human volunteers Consumer studies Legal, Fair, Truthful, Honest, Evidence, Informed Decision-Understandable, Safe

15 Body of Evidence It is from the collective weight of evidence that you construct and write your product claim(s) and provide proof of product performance

16 Anatomy of a Claim(s) What the product says it does e.g. it moisturises the skin What the product actually does e.g. it repairs the skins barrier Why the product does what it does e.g. skin barrier scientific research etc. Weight of Evidence

17 Anatomy of a Claim(s) What the product says it does Marketing What the product actually does Let s improve the flowers with some perfume, cut off the thorns and trim the roots! Why the product does what it does

18 Rules of Engagement 1. What are you/they selling/claiming? How is this communicated? Honest, Truthful, Common sense,. EU Criteria? 2. What is the mechanism of action? 3. How was it tested? What concentrations of the ingredient were used? Were proper controls in place? Are/were the methods clearly described? Is the data valid and relevant AND Is all of the data being presented? Is relevant statistical significance demonstrated? Does the generated data support the suppliers conclusions? 4. How does/will this impact on final formulation clinical testing? How will this ingredient work in the final formulation? What pre-formulation work and proof of principle testing has been conducted?

19 Types of NOC Claims Ingredient Performance Lifestyle Sensory/Aesthetic Endorsement Fluffy Photographic Negative 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.

20 Claims Regulation 655/2013: 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. Claims that the product contains a certain ingredient, this ingredient has to be deliberately present (truthfulness) Claims must not overstate/exaggerate product proven efficacy (honesty) Claims must not state some specific or unique properties, if these aren t unique (honesty)

21 Claims 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. Claims must not extrapolate ingredient properties to the finished product without adequate and verifiable evidence (evidential support) e.g. clinical study Claims must not denigrate any competitors or ingredients legally used/permitted (fairness) Claims must not create confusion with a competitor s product (fairness) Unclear, not understandable, misinformed or irrelevant claims (informed decision-making)

22 Types of Claims Ingredient Active xxx from xxxx helps to stimulate cell regeneration and function xxx maintains original energetic balance and cell respiration. xxxx reduces brown spots and develop a more uniform complexion xxx rebuilds the skin. deliver immediate hydration. xxxx from specially selected xxx extract and the purest xxx xxx extracts protect and restore hair cells. sophisticated xxx heals scars and brightens the skin.

23 Types of Claims Performance A naturally active xxx immediately improves skin radiance and vitality by increasing the skin s metabolism...dramatically encourages a renewed, supple and resilient hair with a glow that shows.. extracted to deliver the highest original active organic molecules to restore and hydrate the skin.

24 Types of Claims Lifestyle A true anti-ageing strategy We do not test on animals 100% Natural Goodness Organically formulated Need to qualify these statements

25 Types of Claims Sensory-Aesthetic..balanced combination of xxx rich oils are easily absorbed to xxxx and condition your hair..with heavenly blossoms to seduce your senses immediately improves skin radiance..elegant and refined..with a conditioned glow that shows..rich and emollient

26 Types of Claims Endorsement Need to be Professional: Trichologists/professional hair salon Dermatologists Dentists Legal Consumer bodies - Which, StiWa etc Magazine tests - Good Housekeeping, Woman & Home - be wary!

27 Types of Claims Fluffy Because you re worth it Dynamic Truly remarkable Sophisticated Beautiful A true beauty strategy.. A blend of remarkable actives..although not obligatory - you can always ask the consumer to agree or not!

28 Types of Claims Photographic 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 t h a t t h e s e p r o d u c t s h a v e characteristics or functions which they do not have. The Fragrance sector of our industry is notorious for claims non-compliance

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30 Types of Claims Free-from : No/without/does not contain silicones No/without/ sulphates No/without/ parabens Chemical - free Negative The Free-From experiment has back-fired Chris Flower Dir. Gen., CTPA Informed Decision Honesty Denigrating - Fairness Against animal testing Not tested on animals Cruelty-free Non-Comedogenic Non-allergenic Fragrance-free Gluten-free Does not contain animal derived ingredients Legality Denigrating - Fairness Honesty Skin risk aversion Vegans (ok)

31 Medical, Drug, Borderline Claims Claims treating or preventing skin diseases using words or phrases which present a medicinal/curative/healing intent are not permitted whatsoever: e.g. cures, heals, treats, restores, prevents, clears etc. Heals dermatitis, eczema Anti-inflammatory Diminishes scars Repairs damaged skin Anti-acne Stimulates metabolism Cures baldness Anti-cellulite Whitens the skin 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. (see also: GUIDANCE DOCUMENT ON THE DEMARCATION BETWEEN THE COSMETIC PRODUCTS DIRECTIVE 76/768 AND THE MEDICINAL PRODUCTS DIRECTIVE 2001/83 AS AGREED BETWEEN THE COMMISSION SERVICES AND THE COMPETENT AUTHORITIES OF MEMBER STATES).

32 And Finally.

33 Legislation Impact & Cost of Non-Compliance All Stakeholders Affected Small companies do not believe the law applies to them - assume they are under the radar If they are saying that... why can t we? What s the big deal... it s just a cosmetic! We are furious about the claims issue and do not want to cooperate The bigger the company the bigger the risk!

34 Legislation Impact & Cost of Non-Compliance Companies fail (even ignore!) to realise the impact on: Industry credibility Consumer Employer/Company Loss of revenue, integrity etc All Stakeholders Affected EVIDENCE HONESTY INTEGRITY FAIRNESS TRUTHFUL INFORMED LEGAL RELEVANT

35 Issue that: Whilst certain commonality across the EU there are still country-country differences, when there should not be - at least in theory. Social and cultural differences exist between countries including consumer and legislative expectations as well as language (translation variances). Disagreements exist between different EU competent authorities and between claims experts. Final decisions remain with the inspectors and the various national legal courts.

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37 CALLAGHAN CONSULTING INTERNATIONAL Thank you for your attention! YOUR INDEPENDENT CONSULTANT PARTNER IN DERMATOLOGY FOR SKIN SCIENCE PRODUCT DEVELOPMENT, & EU COSMETIC CLAIMS LEGISLATION ADVICE