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How many food contact materials are SVHCs?

Food contact materials generic approach risk management

This study identifies European Union approved food contact materials that meet the criteria of a substance of very high concern (SVHC).

What is the Union List?

The Union List 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. The list specifies authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids.

The Union List is a list of approved food contact materials in Europe.

What are SVHCs?

REACH Article 57 sets the intrinsic hazards criteria for substances to be included in Annex XIV (i.e. the Authorisation List). Substances that meet these criteria may be added to the Candidate List of substances of very high concern (SVHC) for Authorisation. The criteria are;

  • Classification in the hazard class carcinogenicity category 1A or 1B;
  • Classification in the hazard class germ cell mutagenicity category 1A or 1B;
  • Classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development;
  • Persistent, bioaccumulative and toxic (PBT);
  • Very persistent and very bioaccumulative (vPvB); and
  • Substances such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points above.

Study

Methodology

Use EC and CAS numbers to match entries on the Union List to lists of SVHCs published by the European Chemicals Agency (ECHA).

Data sources

Tools

  • Microsoft Excel
  • Microsoft Access

Results

  • 35 of the 1,072 entries on the Union List can currently be regarded as subsatnces of very high concern (SVHC);
  • At least 26 further entries are under review; and
  • Approximately 33% of entries on the Union List do not have an EC or CAS number and, therefore, were not included in the study.
Download a PDF file of the Union List substances that are SVHCs

Download a PDF file of the Union List substances that are SVHCs

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Steven Brennan

Steven is a Regulatory Consultant and helps companies to maintain compliance with chemical regulations. He writes about REACH, RoHS and other environmental regulations in his spare time.

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