New regulations affecting Skin Care ALAIN KHAIAT, PH. D. SEERS CONSULTING 1

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1 New regulations affecting Skin Care ALAIN KHAIAT, PH. D. PRESIDENT SEERS CONSULTING LIFETIME ACHIEVEMENT AWARD IN -COSMETICS, PARIS 2010 SEERS CONSULTING 1

2 Animal Testing SEERS CONSULTING 2

3 Animal testing regulation in EU The EU regulation 1223/2009 published 30 November 2009 bans the use of animal tests for the safety of finished products and extend the ban to all tests done on ingredients as of 11 March 2013; Is that a blanket ban? What to do if another country or another regulation demands tests on animals on a product or an ingredient? SEERS CONSULTING 3

4 Animal testing regulation in EU The EU Commission gave the rules of interpretation: The ban is on tests meant to meet the cosmetic regulation; Animal tests can be done if required to meet other regulations e.g. REACH, or other country s regulations; BUT: results cannot be used to assess the safety of the cosmetic product; SEERS CONSULTING 4

5 Animal testing regulation in India Rule 145-C states bluntly no person shall use any animal for cosmetic testing ; Draft rule 135-B reinforces: no cosmetic tested on animal shall be imported ; Both rules do not give information on ingredients (included or not); no information on the date of application of the ban; no grace period; etc. SEERS CONSULTING 5

6 Animal testing elsewhere The State of Sao Paolo has banned animal testing, but the rest of Brazil has not; Israel has banned animal testing following EU; In the future, we will see more and more countries following the ban and, de facto, suppliers are no longer testing the new RM on animals; SEERS CONSULTING 6

7 Animal Testing and the actual situation To register your product in China, you have to submit samples which are tested on animals but whatever the results, you can t use them to assess the safety of the product in EU; To register a new ingredient in China or for Quasi-Drug in Japan, you must have your ingredient tested on animals, but you can t use the data to assess the safety in EU; To meet EU REACH regulation, you must have your ingredient tested on animals, but the results cannot be used to determine the safety in a cosmetic product; RM suppliers have stopped all animal safety tests for cosmetics; SEERS CONSULTING 7

8 Sun Care regulations SEERS CONSULTING 8

9 ISO and Sun Care Publication of ISO standards which cover: ISO 24442: 2011 UVA protection in vivo; ISO 24443:2012 UVA protection in vitro; ISO 24444:2010 SPF in vivo; Adoption of the ISO and ISO in EU, US and Australia (with some slight differences); Adoption of ISO and ISO in Japan; SEERS CONSULTING 9

10 SPF It s finally clear! One needs to follow the ISO to determine the SPF of a product; But there are still some variations between the US and the ISO standard and some other countries; SEERS CONSULTING 10

11 UVA PF Most countries have adopted or accept the ISO for in vitro determination of PFA a more reproducible, more ethical test method than the in vivo ISO (the only one accepted in Japan and Korea); SEERS CONSULTING 11

12 SEERS CONSULTING 12 From Dermatest December 2013 Newsletter

13 Claims In EU: The ratio of UVA PF / SPF must be >1/3 Critical Wavelength: this is the wavelength that gives 90% absorption under the curve. Must be >370nm; In the US: If the Cw is > 370 nm then the product can be labelled Broad spectrum ; SEERS CONSULTING 13

14 Critical Wavelength SEERS CONSULTING 14

15 Claims Do not stay too long in the sun even while using a sunscreen product is a mandatory statement in EU and ASEAN; Claims like Sunblock, Waterproof, 24h protection are banned in EU, US, Australia and ASEAN; Water resistance : ISO group is working on a method; Maximum SPF: in EU, Japan, Australia, New Zealand: 50+ ; in US the FDA is considering 60+ but ask for justification above; in China 30; in Korea and India 50; SEERS CONSULTING 15

16 Countries regulations SEERS CONSULTING 16

17 China CFDA has issued the list of ingredients that can be used in cosmetics: 8,783 ingredients are on the list vs. over 20,000 in INCI! If your product formula uses only ingredients from the list, you can submit it for registration; If you want to use an ingredient which is not on the list, you first have to register the ingredient; In the last 4 years only 3 ingredients have been approved! China positive list is a major blockage to innovation and consumers travel to other countries, to buy the latest product they want! SEERS CONSULTING 17

18 India GSR 137 related to metrology of packaged goods requires cosmetics to bear on the top of the main display panel a: Red or brown dot for non-vegetarian products; Green dot for vegetarian products; The rule was published on 17 June 2014, with a date of application of 1 st July 2014! There is no definition of vegetarian cosmetics, there is no grace period. The industry associations are fighting the rule; SEERS CONSULTING 18

19 Nanomaterials and Stem Cells SEERS CONSULTING 19

20 Nanomaterials There are multiple definitions of what a nanomaterial is. They do have some common points: Must be insoluble or biopersistant; Must be intentionally made; Must have one dimension <100nm; Include primary particles and agglomerates; Challenges: Size distribution threshold: which fraction of the size distribution must be <100nm; Method of characterization: How to measure the size? Each method gives a different result; SEERS CONSULTING 20

21 Nanomaterials in cosmetics The following nanomaterials have been assessed by the SCCS and deemed safe: Titanium dioxide; Zinc oxide; Carbon black; Tinosorb MBBT or 2,2 -Methylene-bis(6-(2H-benzotriazol-2-yl)-4- (tetramethyl-butyl)-1,1,3,3-phenol);2,2 -Methylenebis(6-(2H-benzotriazol-2- yl)-4-(1,1,3,3-tetramethylbutyl)phenol); SEERS CONSULTING 21

22 Nanomaterial in Cosmetics EU requirement to inform the commission on the use of nanomaterials (other than colors, preservatives or UV filters) and notify 6 months before placing in the market; If it has concerns regarding the safety, the commission must ask the SCCS for safety assessment and the SCCS must respond within 6 months. In case of issues on safety, the Commission will amend Annex II or III; The EU commission is to issue a catalog of all nanomaterials used in cosmetics (July 2014) and update it regularly; SEERS CONSULTING 22

23 Stem Cells While human origin ingredients are banned in many countries (EU, ASEAN, China, etc.), the use of the word stem cells is being evaluated in many places and some countries are banning it; even if it refers to botanical stem cells activators; SEERS CONSULTING 23

24 Thank You SEERS CONSULTING 24