Colorants for Plastics are our Playground PRODUCT STEWARDSHIP: ONE STEP AHEAD WITH CLARIANT

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1 Colorants for Plastics are our Playground PRODUCT STEWARDSHIP: ONE STEP AHEAD WITH CLARIANT Public Colorants for plastics Business Unit Pigments

2 2 Public, Colorants for Plastics are our Playground Table of Contents Introduction: Organic Pigments under REACh Specific Regulations: Food Contact and Toys Committed to Sustainability and Quality For detailed information about regulatory compliant products please consult our product literature

3 Introduction ORGANIC PIGMENTS UNDER REACH Public Colorants for plastics Business Unit Pigments

4 4 Public, Colorants for Plastics are our Playground Pigments under the REACh Regulation One step ahead with Clariant Clariant s Intelligent Testing Strategy (ITS) is one cornerstone in the safety evaluation of organic pigments ITS helps to reduce the number of animal tests ITS accelerates REACh registrations, saves costs & resources Clariant and its BU Pigments is among the leading REACh registrants for organic pigments Source: Clariant Corporate Sustainability Report 2011

5 5 Public, Colorants for Plastics are our Playground Pigments under the REACh Regulation One step ahead with Clariant Clariant has pro-actively participated in REACh from the beginning ETAD* members have formed seven organic pigment consortia for Phase 1 - Copper Phthalocyanine Pigments (e.g. P.B. 15, P.G. 7) - Diarylide Yellow Pigments (e.g. P.Y. 12, 13, 81, 83) - Metal Lake Pigments (e.g. P.Y. 48:x, 52:x, 57:x) - Quinacridone Pigments (e.g. P.V. 19, P.R. 122) - P.Y. 74 (lead company Clariant) - P.V. 23 (lead company Clariant) - P.R. 112 (lead company Clariant) All in all, Clariant has registered 24 organic pigments in REACh Phase 1 *ETAD = Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers

6 6 Public, Colorants for Plastics are our Playground Pigments under the REACh Regulation One step ahead with Clariant Five more organic pigment multi-substance consortia have been formed for Phase 2 registrations In all cases, Clariant has been the lead company: - Acetolone Pigments (e.g. P.Y. 120, 151, 154, 175, 180, 181, P.O. 36, 62) - Naphtholone Pigments (e.g. P.R. 176, 185, 208, P.V. 32, P.Br. 25) - Naphtol AS Pigments (e.g. P.R. 2, 14, 146, 170, 187, 188) - Monoazo Yellow Pigments (e.g. P.Y. 1, 3, 73, 97) - Disazo Pyrazolone Pigments (e.g. P.O. 13, 34) All in all, Clariant has registered 48 organic pigments in REACh phase 2 Further more, Clariant has started with more registrations for phase 3 which are due in 2018

7 Specific Regulations: Food Contact and Toys OVERVIEW OF SOME IMPORTANT REGULATIONS Public Colorants for plastics Business Unit Pigments

8 8 Public, Colorants for Plastics are our Playground EU: PIM (Plastics Implementation Measure) EU Commission Regulation 10/2011 Scope: Plastic materials and articles intended to come into contact with food General: Approved substances which can be used in said plastic materials and articles It contains a positive list of 885 substances, for ca. half of them maximal specific migration values (SMLs) are given Colorants are excluded, however since colorants may contain additives it is advantageous to use additives which are positively listed Requirements and testing (migration): - Testing (migration test) has to be carried out with the final article - The article must not exceed the SMLs for the individual substances given, no matter where they originate from (e.g. processing aid, polymer additive or from the pigment)

9 9 Public, Colorants for Plastics are our Playground Germany: BfR Recommendation IX* Scope: Colorants for food contact applications General: Definition of purity criteria The Recommendations on Food Contact Materials (formerly Plastics Recommendations ) are based on European law and its transposition into national law, however they are not legal norms Requirements and testing (heavy metals and amines): - 1. Concentrations of certain heavy metals soluble in 0.1 N hydrochloric acid must not exceed certain limits (tested with the colorant) - 2. The content of primary aromatic amines soluble in 1 N hydrochloric acid must not exceed 0.05 % (calculated as aniline). This limit does not apply for primary aromatic amines containing carboxyl or sulpho groups. *BfR = Bundesinstitut für Risikobewertung (Federal Institute for risk analysis)

10 10 Public, Colorants for Plastics are our Playground EU: European Resolution AP (89) I Scope: Colorants in plastic materials coming into contact with food General: Definition of purity criteria It has not the status of a national law, but it can be regarded as a guidance how to establish the safety of materials for use in food-contact applications throughout Europe Requirements and testing (heavy metals and amines + PCBs) - Heavy metal limits: Certain limiting values must not be exceeded (extractables in 0.1 N HCl) - Amines: unsulphonated primary aromatic amines soluble in 1N HCl max. 500 ppm (calculated as aniline). Sulphonated aromatic amines max. 500 ppm (calculated as aniline sulphonic acid). Benzidine, ß-naphthylamine and 4- aminobiphenyl, 2-methyl-4-chloroaniline single or in total max. 10 ppm - PCBs: polychlorinated biphenyls (PCB) max. 25 ppm

11 11 Public, Colorants for Plastics are our Playground France: French Positive List Scope: Coloration of plastics for food contact General: Positive listing / purity criteria Combination of a positive listing of pigments and dyes for the coloration of food contact articles and purity criteria regarding heavy metals and amines Requirements and testing (heavy metals): - Purity criteria regarding heavy metals and amines (as in AP (89) I) - Colorants must be listed in Circulaire No. 176 or in the subsequently published appendices

12 12 Public, Colorants for Plastics are our Playground EU: EN 71-3 Heavy Metals Scope: Colorants for toys in the European Union (EN 71-1 to EN are the related European standards) General: Definition of purity criteria Legal basis for EN 71 are European regulations (2009/48/EC Toy Safety Directive ) Recently (as of 20 July 2013) its Annex II came into force which lays down certain chemical requirements Requirements and testing: - Heavy metal limits: Certain limiting values must not be exceeded in the final article (extractables in 0.07 N 37 C) - Clariant follows ETAD s recommendation for total element limits for organic pigment products sold into toys which enables manufacturers to assess the conformity of its toys with the Toy Safety Directive

13 13 Public, Colorants for Plastics are our Playground USA: FDA Food Contact Compliance (Food and Drug Administration) Scope: Coloration of plastics for food contact General: Positive listings Colorants belong to the group of indirect food additives (or food contact substances), they must be approved by regulation, exemption or have preclearance (food contact notification, FCN) Positive listings of colorants: - Regulated colorants (listed in 21 CFR ) - Effective list of food contact substance notifications (from the year 2000 on) Requirements and testing (for new FCN) - Migration tests to determine the amount of colorant which migrates from a polymer into the food (using defined food simulants and conditions) - Toxicological data depending on the migration values (higher migration values -> more extensive data)

14 One step ahead with Clariant COMMITTED TO SUSTAINABILITY AND QUALITY Public Colorants for plastics Business Unit Pigments

15 15 Public, Colorants for Plastics are our Playground Clariant makes significant investments into Sustainability, Safety, Quality and Compliance Commitment to Sustainability: Clariant has signed the Responsible Care declaration if the International Council of Chemical Associations (ICAA) A global Product Stewardship Organization with acknowledged regulatory and toxicological experts Global network and presence as a company or in industry associations Highest environmental and EH&S standards, valid for each site around the globe Outstanding quality control and analytical expertise

16 16 Public, Colorants for Plastics are our Playground Commitment to Sustainability Clariant s environmental goals for 2020: Energy consumption to be cut by 30 percent Direct CO 2 emissions to be reduced by 45 percent Direct and indirect emissions of greenhouse gases to decrease by 35 percent Water usage to be reduced by 25 percent The volume of effluents to drop by 40 percent The volume of waste to fall by 45 percent

17 17 Public, Colorants for Plastics are our Playground Commitment to Quality Clariant s quality, environmental and safety management is globally certified to the ISO 9001, ISO and OHSA standards, thus guaranteeing its customers internationally established standards for the quality of products, business processes, safety and environmental protection.

18 18 Public, Colorants for Plastics are our Playground Commitment to Quality Clariant has an own extensive network of quality control and analytical laboratories, amended by external partners Outstanding expertise in specific analytical methods to safeguard product quality and compliance especially for dyes and pigments, e.g.: Classical Analytics (e.g. titrations, gravimetry, digestions and preparations) Chromatography (e.g. HPLC, GC, GPC, IC, TLC and coupling techniques) Spectroscopy (e.g. MS, IR, NIR, UV/VIS, NMR) Atomic Spectroscopy (e.g. AAS, ICP-OES, ICP-MS) Physical Methods (e.g. particle size and PSD, rheology, light and weather fastness) Special Tests for Pigments

19 19 Public, Colorants for Plastics are our Playground Clariant Disclaimer This information corresponds to the present state of our knowledge and is intended as a general description of our products and their possible applications. Clariant makes no warranties, express or implied, as to the information s accuracy, adequacy, sufficiency or freedom from defect and assumes no liability in connection with any use of this information. Any user of this product is responsible for determining the suitability of Clariant's products for its particular application. Nothing included in this information waives any of Clariant s General Terms and Conditions of Sale, which control unless it agrees otherwise in writing. Any existing intellectual/industrial property rights must be observed. Due to possible changes in our products and applicable national and international regulations and laws, the status of our products could change. Material Safety Data Sheets providing safety precautions, that should be observed when handling or storing Clariant products, are available upon request and are provided in compliance with applicable law. You should obtain and review the applicable Material Safety Data Sheet information before handling any of these products. For additional information, please contact Clariant. For sales to customers located within the United States and Canada the following applies in addition NO EXPRESS OR IMPLIED WARRANTY IS MADE OF THE MERCHANTABILITY, SUITABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE OF ANY PRODUCT OR SERVICE. 9/2010 Product and service marks protected by Clariant in many countries * Product and service marks licensed by Clariant in many countries 2013 Clariant International Ltd, Rothausstrasse 61, 4132 Muttenz, Switzerland

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