REACH Annex XVII Scope - Substance vs. Manufacturing Process?

Question: We follow the same manufacturing process as a coated wire company, but use 1-methyl-2-pyrrolidone (NMP) for the manufacture of medical tubing. Does the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation Restriction List (Annex XVII) apply to the substance, or the manufacturing process in which it is used?

Answer: The REACH restriction on NMP applies to the substance, and the implementation date and exemption until 2024 are for the specific process of wire coating. Manufacturing companies that use the same process but are not manufacturing wire coating are not in scope.

It should be noted that the restriction of NMP as a process chemical only applies to manufacturing processes that occur within the EU. If NMP is used in the manufacture of a product outside the EU, but it is no longer present once the product enters the European Economic Area (EEA), it cannot be regulated against.

This content is accurate as of June 21, 2019.

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