The (EU) Regulation 2018/1513 was published in a "fast track" procedure and the new restrictions included in Entry 72 of Annex XVII. The new concentration limits apply to CMR substances (carcinogenic, mutagenic, reproductive toxicity) in clothing, textiles that come into contact with the skin and footwear. If the limits are exceeded, these products may no longer be placed on the market after 1 November 2020.
The restrictions set forth in REACH Annex XVII serve to protect consumers from specific substances and restrict their use in specific, particularly relevant areas. Typical restrictions include, for example, nickel in costume jewellery, formaldehyde in cleaning agents, PAH in plastic parts or azo dyes in textiles.
In October 2015, the EU Commission announced its plans to restrict CMR substances in textiles. The procedure for enacting the restriction was developed using the "fast-track" procedure outlined in REACH Art. 68(2). In this abridged procedure, certain elements of the normal procedure such as the preparation of an Annex XV dossier and opinions by RAC and SEAC can be avoided. In this case it was justified by the fact that the harmfulness of the substances concerned had already been sufficiently proven, since only substances classified as CMR 1A or 1B were eligible for inclusion in the restriction.
The number of substances considered for inclusion in the restriction was initially relatively high at 286. In the following consultation rounds and public hearings, the list of substances was reduced to 33 CMR substances. Entry No 12 of Annex XVII contains 33 substances of the following groups:
Appendix 72 lists specific limit values for each substance. As far as concentration limits are concerned, where different limits are set in other entries in Annex XVII of REACH or in other EU legislation, the stricter concentration limit always applies. This applies, for example, to the concentration limits for polycyclic aromatic hydrocarbons (PAHs) in Entry 50 and in the Toy Directive 2009/48/EC.
A list of available analytical methods for specific matrices that can be used to determine the different substances is provided in the ECHA Guidance Document. The document recommends using the most effective method in each case.
Clothing or related accessories such as:
Textiles other than clothing which, under normal or reasonably foreseeable conditions of use, come into contact with human skin to an extent similar to clothing:
Footwear
Printing and coatings applied directly to textile items are subject to the restriction.