Substance Information

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REACH Registration data can be found in the new ECHA CHEM database. The old ‘Registered substance factsheets’ will be available on this web site during the transition period but have not been updated since 19 May 2023. More

 

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IC

Confidential or not yet assessed substance

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Regulatory context

Here you can find all of the regulations and regulatory lists in which this substance appears, according to the data available to ECHA. This substance has been found in the following regulatory activities (directly, or inheriting the regulatory context of a parent substance):

REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation
PIC - Prior Informed Consent Regulation
Active Implantable Medical Devices Directive-repealed
  • Active Implantable Medical Devices Directive - Hazardous Substances
    EU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007

    This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Cosmetic Products Regulation
  • Cosmetic Products Regulation, Annex III - Restricted Substances
    EU. Restricted Substances: Annex III, Regulation 1223/2009/EC on Cosmetic Products, as amended by Regulation (EU) 2023/1545, OJ L 188, 27 July 2023

    This list contains substances whose use in cosmetic products in the European Union is banned, except under certain conditions as indicated in Annex III. The list specifies the field of application or use, maximum allowable concentration limits in finished products, and any additional limitations.

Food Contact Recycled Plastic Materials and Articles Regulation-repealed
  • FCMs Recycled Plastic & Articles Regulation - Annex I - Authorised Use
    EU. Plastic Food Contact Materials (FCMs) per Regulation 10/2011/EU (Union List), Directive 282/2008/EC on Recycled Plastic FCMs, 28 March 2008, amended by Regulation 2015/1906/EU, 23 October 2015

    This list contains the Annex I Plastic Food Contact Materials (FCMs) authorised for use in the European Union under Regulation 10/2011/EU. Pursuant to Art. 4(b) of Directive 282/2008/EC on recycled plastic FCMs, plastic recycling processes can only be authorised if input originates from plastic materials and articles manufactured in accordance with EU legislation on plastic food contact materials and articles.

In Vitro Diagnostic Medical Devices Directive-repealed
  • In Vitro Diagnostic Medical Devices Directive - Hazardous Substances
    EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

    This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Medical Devices Directive-repealed
  • Medical Devices Directive - Hazardous Substances
    EU. Hazardous Substances for Purposes of Medical Devices Directive 93/42/EEC, 12 July 1993, amended by Directive 2007/47/EC, 21 September 2007

    This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). Specifically, the non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Pesticide Residues Regulation
  • Annexes II, III, IV, VII - Defined & Temporary Maximum Residue Levels
    EU. Pesticides. Maximum Residue Levels: Annexes II, III, IV, VII, Regulation 396/2005/EC, last amended by Regulation (EU) 2023/1719, OJ L 223, 11 September 2023

    This list contains the maximum residue level (MRLs) entries as listed in the following annexes of Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC: (1) Annex II: Maximum Residue Levels; (2) Annex III: Temporary MRLs; (3) Annex IV: Active Substances for Which No MRLs Are Required; and (4) Annex VII: Active Substance/Product Combinations.

Plastic Materials and Articles Regulation
  • FCM and Articles Regulation, Annex I - Authorised Substances
    EU. Union List of Authorized Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation (EU) 2023/1627, OJ L 201, 11 August 2023

    This list contains the Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids. It is taken from Annex I of the Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

Recycled Plastic Food Contact Materials
  • Recycled Plastic FCMs - Regulation (EU) 2022/1616
    EU. Recycled Plastic FCMs per Regulation 10/2011/EU (Union List), Regulation (EU) 2022/1616, OJ L 243 of 20 September 2022, as corrected by a corrigendum, OJ L 244 of 21 September 2022

    The list contains the Union list of authorised substances for the purposes of compositional requirements related to recycled plastic FCMs. The list is taken from Annex I to Commission Regulation (EU) No 10/2011. Recycled plastic FCMs shall comply with the requirements set out in Regulation (EU) No 10/2011. In addition, plastic waste inputs shall originate only from plastic materials and articles manufactured in accordance with Regulation (EU) No 10/2011.