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Conformity of Pigments with Statutory Regulations

We at EMD Performance Materials 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 relating 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.

EMD Performance Materials works with national and international regulatory authorities, chemical industry associations (VCI, CEFIC) as well as scientific working groups. In addition, 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. EMD Performance Materials will inform you of the chemical inventory status of the pigment ingredients in the eight most important chemical inventories worldwide.
Do you have any regulatory questions concerning our technical pigments? If so, please do not hesitate to contact us.

Find out more about the regulatory approvals of pigments in:

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.

 

Inventories

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

  • Canada (DSL/NDSL)
  • USA (TSCA)
  • Europe (EINECS/ELINCS)
  • Australia (AICS)
  • China (NEPA)
  • Japan (ENCS)
  • Korea (ECL)
  • Philippines (PICCS)
 

Packaging Materials

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. EMD Performance Materials fulfills these requirements or their pigments from the Iriodin®, Miraval®, Colorstream®, Minatec® and Xirallic® product portfolios.

USA:
In US this regulation is described as CONEG regulation (Coalition of Northeastern Governors).
 

Food packaging material

Europe:
The requirements for colorants used in food packaging material are sourced mainly from the European Council Resolution AP(89) 1, where some heavy metal threshold limits next to some aromatic amines are emphasized. EMD Performance Materials fulfills these requirements for most of our pigments from the Iriodin®, Miraval® and Colorstream® product portfolios. The so-called “no migration principle” which states that no substance may be able to migrate into the foodstuffs, is fully the responsibility of the final food packaging material producer.

USA:
For the use of pigments in food packaging material, EMD Performance Materials declares in most cases the compliance with FDA paragraphs 21 CFR 178.3297 for the use of colorants in polymers. For some of our pigments we have “food contact notifications” (FCN).

 

Plastics Directive

Directive 2002/72/EC and regulation EC 10/2011 describe the requirements for the use of substances, monomers and additives used in plastic materials intended to come into contact with foodstuffs. The purity requirements must be fulfilled by the end material producer (plastics material producer).

 

Safety of toys

Europe:
In EN 71 Part 3 the requirements for the use of colorants in toys are established. The main requirements are heavy metal thresholds to be fulfilled for the use of colorants in toys. EMD Performance Materials fulfills these requirements for most of our pigments of the Iriodin®, Miraval® and Colorstream® product portfolios.

 

German Tobacco Decree (1977)

Due to the fact that all ingredients of the pigments must meet the purity criteria mentioned in Appendix 1 as well as the general and specific purity criteria of the European legislation on food additives (Commission Directive 95/45/EC laying down specific purity criteria concerning colors for use in foodstuffs), we recommend the use of Candurin® and some of the cosmetic pigments based on mica in combination with titanium dioxide and/or iron oxide.

 

RoHS (Restriction of certain hazardous substances)

Directive 2002/95/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment determines that as of 1 July 2006, new electrical and electronic equipment put on the market do not contain lead, mercury, cadmium, hexavalent chromium in the following threshold limits: Pb, Hg and Cr (VI) < 0.1 % (by weight, each metal), Cd < 0.01 % (by weight), no polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE) are allowed. We fulfill these requirements for our pigments of the Iriodin®, Miraval®, Colorstream®, Minatec® and Xirallic® product portfolios.

 

Directive 2000/53/EC

In compliance with Directive 2000/53/EC of the European Parliament and the Commission Decision of 27 June 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 after 1 July 2003 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 pigments of the Iriodin®, Miraval®, Colorstream®, Minatec® and Xirallic® product portfolios.