Finnish Safety and Chemicals Agency (Tukes) Restrictions for Certain Substances, CMR Substances and Nanomaterials Jarkko Loikkanen, Senior Officer TAIEX Workshop on the Introduction of EU Legislation on Cosmetic Products February 2016, Belgrad (Serbia)

Finnish Safety and Chemicals Agency Topics Jarkko Loikkanen, TAIEX Workshop 2016  RESTRICTIONS FOR SUBSTANCES LISTED IN THE ANNEXES o Annexes II-VI and their amendment  SUBSTANCES CLASSIFIED AS CMR o CLP regulation (No 1272/2008) o Carcinogenicity, germ cell mutagenicity, reproductive toxicity  TRACES OF PROHIBITED SUBSTANCES  NANOMATERIALS

Finnish Safety and Chemicals Agency Annexes II – VI to EU’s Cosmetics regulation (1223/2009) o Annex II: List of substances prohibited in cosmetic products o Annex III: List of substances which cosmetic products must not contain except to the restrictions laid down o Annex IV: List of colorants allowed in cosmetic products ( others not allowed to use ) o Annex V: List of preservatives allowed in cosmetic products ( others not allowed to use ) o Annex VI: List of UV filters allowed in cosmetic products ( others not allowed to use ) NB: 1) Substances listed in Annexes III to VI do not cover nanomaterials, except where specifically mentioned 2) Substances in Annexes IV – VI may have substance specific restrictions and mandatory warning labelling Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency Restrictions for substances in Annexes II - VI Jarkko Loikkanen, TAIEX Workshop 2016  Annex II: prohibited substances  Restrictions in Annexes III – VI can be related e.g. to  Maximum concentration  Product type ( e.g. hair product, oral product, rinse-off or leave-on product )  General or professional use  Use of substances listed in Annexes III – VI may require wording of conditions of use and warnings; e.g.:  Avoid contact with eyes  Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “black henna” tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary “black henna” tattoo in the past

Finnish Safety and Chemicals Agency Substances in Annexes II - VI Jarkko Loikkanen, TAIEX Workshop 2016  Primarily based on risk assessment by the SCCS  Scientific Committee on Consumer Safety  Mandates and opinions can be found:  Risk assessment procedure  Hazard identification  Dose-response assessment  Exposure assessment  Risk characterisation  Guidance  The SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation (9th revision):  Safety evaluation of cosmetic ingredients and finished cosmetic products

Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 SCCS/1564/15

Finnish Safety and Chemicals Agency Amendments of Annexes to Cosmetics Regulation Jarkko Loikkanen, TAIEX Workshop 2016  Commission Regulation (EU) No 344/2013 (Annexes II, III, V and VI)  Commission Regulation (EU) No 483/2013 (Annex III)  Commission Regulation (EU) No 658/2013 (Annexes II and III)  Commission Regulation (EU) No 1197/2013 (Annex III)  Commission Regulation (EU) No 358/2014 (Annexes II and V)  Commission Regulation (EU) No 866/2014 (Annexes III, V and VI)  Commission Regulation (EU) No 1003/2014 (Annex V)  Commission Regulation (EU) No 1004/2014 (Annex V)  Commission Regulation (EU) No 2015/1190 (Annex III)  Commission Regulation (EU) No 2015/1298 (Annex II and VI)

Finnish Safety and Chemicals Agency Hair dyes  Hair dye strategy  Potential risk of bladder cancer  European Commission, Member States and stakeholders in 2003  Strategy for safety assessment and to regulate hair dyes  Ban permanent and non-permanent hair dyes, if  No safety information by industry  Scientific Committee gives negative opinion  Hair dye substances  > 300 substances identified  So far 181 substances banned (Annex II)  106 substances assessed by the SCCS (in Annex III)  Recently the SCCS assessed 8 substances → Amendment of Annex III  More information: Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency Hair dyes  Commission Regulation (EU) 2015/1190  Added new entries 288 – 296 to Annex III  HC Blue No.17  HC Blue No.15  Acid Green 25  Acid Violet 43  2-p-Phenylenediamine and 2-p-Phenylenediamine Sulfate  Hydroxyanthraquinone-amino-propyl Methyl Morpholinum Methosulfate  Disperse Red 17  Acid Black  Pigment Red 57  Limit the maximum concentration and appropriate warnings  Applies from 10 August 2016 Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency Fragrances  Terms ”parfum” or ”aroma” used in the list of ingredients  The presence of 26 fragrance allergens must be indicated in the list of ingredients also by INCI names, if the following concentrations are exceeded (Annex III)  0.01% rinse-off products  0.001% leave-on products  Recent assessment of fragrance allergens (SCCS/1459/11 )SCCS/1459/11  Proposal by the European Commission  HICC, atranol and chloroatranol → Annex II (ban)  26 ”old” + 63 ”new” fragrance allergens (Annex III)  Amendment of the Annexes in process Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency Substances classified as CMR substances  Harmonized classification according to the CLP Regulation: Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures  C arcinogens o Cat 1A: Known to have carcinogenic potential for humans o Cat 1B: Presumed to have carcinogenic potential for humans o Cat 2: Suspected human carcinogen  Germ cell M utagens o Cat 1A: known to induce heritable mutations in the germ cells of humans o Cat 1B: regarded as if they induce heritable mutations in the germ cells of humans o Cat 2: cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of human  R eproductive toxicants o Cat 1A: Known human reproductive toxicant o Cat 1B: Presumed human reproductive toxicant o Cat 2: Suspected human reproductive toxicant Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency Substances classified as CMR substances (Article 15)  CMR substances (category 1A, 1B ja 2)  General principle: use is banned in cosmetic products  EXCEPTIONS  Substance classified in category 2 may be used (Article 15.1)  SCCS has evaluated and found it safe  Substance classified in category 1A or 1B may be used if ALL of the following conditions are fullfilled (Article 15.2)  Comply with the food safety reguirements (Regulation No 178/2002)  No suitable alternative substances available (analysis of alternatives)  Application is made for a particular use of the product category with a known exposure  SCCS has evaluated and found it safe  List of banned CMR substances in cosmetic products: Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency CMR category 2: TPO (INCI: Trimethylbenzoyl diphenylphosphine oxide)  Use of TPO in cosmetic products  Nail modelling  Not regulated under Cosmetics Regulation (not in Annexes)  CLP Regulation (1272/2008)  Harmonized classification Repro 2  Applied since 1 December 2013 (Commission Regulation 618/2012)  Ban in cosmetic products  Unless exception according to Article 15.1 (SCCS evaluation)  SCCS/1528/14  TPO is safe when used as a nail modelling product (max 5.0%)  Moderate skin sensitizer  Draft Regulation by European Commission: TPO added to Annex III  Use in artificial nail systems safe (max 5.0% w/w)  Use restricted to professionals  COSCOM vote on 22 October 2015  Amendment of Annex III in process Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency CMR category 1B: Formaldehyde  Use in cosmetic products  Preservative (Annex V, max 0.1 or 0.2%)  Nail hardening products (Annex III, max 5%)  CLP Regulation (1272/2008)  Harmonized classification Carc 1B and Muta 2  Applied since 1 January 2016 (Commission Regulations 605/2014 and 491/2015)  Ban in cosmetic products  Unless exception according to article 15.2  Use as preservative is prohibited  Use in nail hardening products  Comply with the food safety requirements (Article a)  Are there suitable alternatives available or not? (Article b)  Application is made for this use ( Article c )  SCCS/1538/14: Safe at 2.2% max concentration for this use (Article d)  Still in process Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency Traces of prohibited substances (Article 17) Jarkko Loikkanen, TAIEX Workshop 2016 “ The non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 3.”  Article 3: Safety requirement (”... Safe for human health…”)  CPSR (Annex I): o The purity of the substances and mixtures o In the case of traces of prohibited substances, evidence for their technical unavoidability o The relevant characteristics of packaging material, in particular purity and stability o Impact on the toxicological profile due to impurities (not necessarily prohibited substance)

Finnish Safety and Chemicals Agency Nanomaterials (Article 16)  Definition (Article 2.1 k): ”means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm “  Article 16.1.: ”For every cosmetic product that contains nanomaterials, a high level of protection of human health shall be ensured”  Labelling requirement (Article 19)  SCCS documents: o Guidance on the safety assessment of nanomaterials in cosmetics (SCCS/1484/12): o Relevance, adeguacy and quality of data in safety dossiers on nanomaterials (SCCS/1524/13; Revision 27 March 2014): o The SCCS notes of guidance for testing of cosmetic ingredients and their safety evaluation 9th revision (SCCS/1564/15): o Addressing the new challenges for risk assessment: Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency Notification of products containing nanomaterial  CPNP notifications according to both Articles 13 and 16  CPNP notification under Article 16 (nano)  6 months prior to being placed on the market  For products which contain ingredients in nano form  CPNP notification on nanomaterial should include at least  Identification including chemical name (IUPAC; mandatory)  Existing other descriptors to facilitate identification (see preamble to Annexes II – VI)  Specification (e.g. size of particles, physical and chemical properties)  Estimate of the quantity of nanomaterial  Toxicological profile  Safety data  Exposure (Reasonably foreseeable exposure conditions)  If human health safety concern, COM can request SCCS’s opinion  COM may amend Annexes II and III  EXCEPTION: CPNP notification under Article 16 not needed if ingredient in nano form is included in such form in Annexes III – VI Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency Catalogue of nanomaterials  European Commission  Not published to date (11 January 2014)  Still under preparation  Catalogue includes:  All nanomaterials used in cosmetic products placed on the market  Separate section for colorants, UV-filters and preservatives  Cosmetic product categories  Reasonably foreseeable exposure conditions  Regularly updated  Publicly available Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency Annual status report to European Parliament and the Council  European Commission  11 July 2014  Report includes:  Information on developments in the use on nanomaterials  Separetate section for clorants, UV-filters and preservatives  Report update summarises e.g.:  New nanomaterials in new categories of cosmetic products  Number of notifications  Progress made in developing nano-specific assessment methods and safety assessment guides  Information on international co-operation programmes Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency SCCS opinions on nanomaterials  SCCS opinions  TiO 2 (nano)  ZnO (nano)  MBBT (nano)  Carbon Black (nano)  Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate (nano)  SCCS mandates:  Coatings (3) for TiO 2 (nano) as UV-filter  TiO 2 (nano) as UV-filter in sunscreen and personal care spray products (max 5.5%)  SCCS (public consultations and opinions):  SCCS (mandates): Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency Zinc Oxide (nano)  Use of ZnO in cosmetics  Colorant (white; CI 77947): entry 144 of Annex IV  Not in Annex VI  Nano form is currently not regulated  SCCS/1489/12 (rev 11 Dec 2012), SCCS/1518/13 (rev 22 Apr 2014), SCCS/1539/14 (rev 25 Jun 2015)  Draft Regulation by European Commission: ZnO (both non-nano and nano) added to Annex VI  Authorization for use a UV-filter except in applications that may lead to exposure of the end user’s lungs by inhalation  Max concentration 25%  Addition of new entries 30 (Zinc Oxide) and 30a (Zinc Oxide, nano)  Allowed nanomaterial should have certain characteristics (SCCS’s opinion)  COSCOM vote on 22 October 2015  Amendment of Annex VI in process Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency Titanium dioxide (nano)  Use of TiO 2 in cosmetics  Colorant (white; CI 77891): entry 143 of Annex IV  UV-filter: entry 27 of Annex VI (max. 25%)  Nano form is currently not regulated  SCCS/1516/13 (rev 22 Apr 2014), SCCS/1539/14 (rev 25 Jun 2015)  Draft Regulation by European Commission: TiO 2 (nano) added to Annex VI  Authorization for use a UV-filter except in applications that may lead to exposure of the end user’s lungs by inhalation  Max concentration 25% (Entry 27a)  Allowed nanomaterial should have certain specifications (SCCS’s opinion)  COSCOM vote on 9 February 2016  Amendment of Annex VI in process Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency Information! o European Commission: en.htm en.htm Jarkko Loikkanen, TAIEX Workshop 2016

Finnish Safety and Chemicals Agency Thank you!