Division 5.2 Restriction based on CLP classified substances and mixtures

With the exception of linings and socks, as defined in Article 2(2) of this Decision, the criterion shall apply when the content of any homogeneous material or article in shoe uppers or shoe outer soles is greater than 3,0 % (weight by weight) of either component. For linings and socks, any homogeneous material or article that is used for linings and socks shall be subject to the restriction as specified in the next paragraph.

Substances and mixtures falling within the groups identified in Table 3 that meet the criteria for classification with the CLP hazards in Table 2 shall not be present in any homogeneous materials or articles that form part of the final product in concentrations higher than 0,10 % (weight by weight).

The use of certain substances and mixtures referred to in Table 3 is exempted from the requirements of criterion 5.2 subject to the conditions specified in Table 4.

Assessment and verification: the applicant shall provide a declaration of compliance with criterion 5.2 supported, where appropriate, by declarations from the material supplier(s). The declaration shall be supported by a list of the substances and/or substances in mixtures as specified in Table 3 that are present in any homogeneous material or article that forms part of the final product, together with information about their hazard classification or non-classification.

The following information shall be provided to support declarations of the hazard classification or non-classification for each substance or mixture:

• the substance's CAS, EC or list number (where available for mixtures);

• the physical form and state in which the substance or mixture is used;

• harmonised CLP hazard classifications;

• self-classification entries in ECHA's REACH registered substance database if no harmonised classification is available^f1;

• mixture classifications according to the criteria laid down in the CLP Regulation.

When considering self-classification entries in the REACH registered substance database, priority shall be given to entries from joint submissions.

Where a classification is recorded as ‘data lacking’ or ‘inconclusive’ according to the REACH registered substance database, or where a substance has not yet been registered under the REACH regulation, toxicological data meeting the requirements in Annex VII to Regulation (EC) No 1907/2006 shall be provided that are sufficient to support conclusive self-classification in accordance with Annex I to Regulation (EC) No 1272/2008 and ECHA's supporting guidance. In the case of ‘data lacking’ or ‘inconclusive’ database entries, self-classifications shall be verified, with the following information sources being accepted:

• Toxicological studies and hazard assessments by ECHA peer regulatory agencies^f2, Member State regulatory bodies or intergovernmental bodies.

• A Safety Data Sheet (SDS) fully completed in accordance with Annex II to Regulation (EC) No 1907/2006.

• A documented expert judgement provided by a professional toxicologist. This shall be based on a review of scientific literature and existing testing data, where necessary supported by results from new testing carried out by independent laboratories using methods recognised by ECHA.

• An attestation, where appropriate based on expert judgement, issued by an accredited conformity assessment body that carries out hazard assessments according to the Globally Harmonised System (GHS) of the classification and labelling of chemicals or CLP hazard classification systems.

Information on the hazardous properties of substances or mixtures may, in accordance with Annex XI to Regulation (EC) No 1907/2006, be generated by means other than tests, for instance through the use of alternative methods such as in vitro methods, by quantitative structure activity models or by the use of grouping or read-across.

For the derogated substances and mixtures listed in Table 4, the applicant shall provide proof that all the derogation conditions are met.

Where EU Ecolabel textile products are used, the applicant shall provide a copy of the EU Ecolabel certificate showing that it was awarded in accordance with Decision 2014/350/EU.