Regulatory affairs for effect pigments

We stand behind our pigments every step of the way – from development up to delivery to you, – our customers. The Regulatory Affairs managers are responsible for legal and safety issues related to our technical pigments. In this capacity, they ensure that the statutory regulations are met. Their tasks also include substance registration in accordance with REACH (Registration, Evaluation and Authorization of Chemical Substances), ensuring the legal conformity of pigments in new application areas, raw material safety evaluations based on toxicological and ecotoxicological data, as well as the environmental relevance of our pigments.

We work together with national and international regulatory authorities, chemical industry associations (VCI, VdmI, CEFIC), as well as scientific working groups. We are represented in the Association of Pigment Manufacturers/Mineral Colors and in the international working groups of the national pigment associations.

Furthermore, we support you when it comes to approval processes and general safety-relevant matters and regulatory questions of all kind. E.g.: We will inform you about the chemical inventory status of the pigment ingredients in the eleven most important chemical inventories worldwide and much more.

We provide information and advice to our customers on application technologies and regulatory matters to the best of our knowledge and ability, but without obligation or liability. Existing laws and regulations are to be observed in all cases by our customers. This also applies in respect to any rights of third parties. Our information and advice do not relieve our customers of their own responsibility for checking the suitability of our products for the envisaged purpose.

For the global marketing of our pigments products from the Iriodin®, Miraval®, Iriotec®, Xirallic®, Colorstream®, Pyrisma®, Spectraval™, Meoxal® and Biflair® product portfolios, we check the inventory status of all ingredients of our pigment formulations in the eleven current chemical inventories:

• Canada (DSL/NDSL)
• USA (TSCA)
• Europe (REACH, separate REACH statement is available)
• Australia (AICS)
• China (IECSC)
• Japan (ENCS)
• Korea (ECL)
• Philippines (PICCS)
• Taiwan (NECI)
• Switzerland (EINECS/ELINCS)
• New Zealand (NzloC)

Europe

Directive 94/62/EC refers to packaging and packaging components with regulations for the heavy metal content in these materials. The sum of the four heavy metals Pb, Cd, Hg, and Cr (VI) must not exceed 100 ppm. Merck KGaA, Darmstadt, Germany fulfills these requirements for their pigments from the Iriodin®, Miraval®, Iriotec®, Xirallic®, Colorstream®, Pyrisma®, Spectraval™, Meoxal® and Biflair® product portfolios.

USA

In the United States, this regulation is referred to as the CONEG/TPCH regulation (Coalition of Northeastern Governors ; Toxics in Packaging Clearinghouse) with the identical content.

Europe

The requirements for colorants used in food packaging materials are sourced mainly from European Council Resolution AP(89) 1, which specifies limits for some heavy metals as well as some aromatic amines and polychlorobiphenyls. Merck KGaA, Darmstadt, Germany fulfills these requirements for many of our pigments from the above-mentioned product portfolios (excluded are surface treated exterior pigments). The “no migration principle”, stating that no substance is permitted to migrate into the foodstuffs in critical amounts, is, however, in the sole responsibility of the final food packaging material producer and has to be tested in the intended final product.

USA

For most cases of use of pigments in food packaging materials, Merck KGaA, Darmstadt, Germany declares compliance with FDA paragraphs 21 CFR 178.3297 for the use of colorants in polymers. For some of our pigments, we have a “Food Contact Notification” (FCN) or an according Legal Opinion for the safe use. Food Contact Statements with detailed description for the according pigments are available on demand.

Regulation EC 1935/2004 and EC 10/2011 describe general safety approaches and the requirements for the use of substances, monomers, and additives in plastic materials that are intended to come into contact with food. The purity requirements must be tested at the finished product by the producer.

Europe

Directive EC 2009/48 (Toy Directive) decribes the requirements for the use of colorants in toys, whereas testing methods are still described under the former EN 71 Part 3 in its most current version. The main requirements are heavy metal limits to be met. Merck KGaA, Darmstadt, Germany fulfills these requirements for many of our pigments of the Technical Pigment product portfolio for the use in solid toys (Cat. III). A separate Toy Statement with detailed description is available on request for our customers.

Directive EC 2011/65 on the restriction of the use of certain hazardous substances in electrical and electronic equipment specifies that - new electrical and electronic equipment put on the market must not exceed the following limits for lead, mercury, cadmium, or hexavalent chromium: Pb, Hg, and Cr (VI) < 0.1% (by weight, each metal), Cd < 0.01% (by weight) and must not contain several phthalates < 0,1% (by weight) We fulfill these requirements for our technical pigments portfolios.

In compliance with Directive 2000/53/EC of the European Parliament and the Commission Decision of June 27, 2002, amending Annex II of Directive 2000/53/EC of the European Parliament and of the Council on end-of-life vehicles, Member States shall ensure that materials and components of vehicles put on the market do not contain lead, mercury, cadmium, or hexavalent chromium other than in cases listed in Annex II under the conditions specified therein; Pb, Hg, and Cr (VI) < 0.1% (by weight, each metal), Cd < 0.01% (by weight). We fulfill these requirements for our technical pigment portfolio.