REACH Annex XVII, entry 29: Substances which are classified as germ cell mutagen category 1A or 1B in Part 3 of Annex ...

Designation of the substance, of the group of substances or of the mixture (official wording)

Substances which are classified as germ cell mutagen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 3 or Appendix 4, respectively.

Conditions of restriction (official wording)

Without prejudice to the other parts of this Annex the following shall apply to entries 28 to 30:

1. Shall not be placed on the market, or used,

- as substances,

- as constituents of other substances, or,

- in mixtures,

for supply to the general public when the individual concentration in the substance or mixture is equal to or greater than:

- either the relevant specific concentration limit specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008, or,

- the relevant generic concentration limit specified in Part 3 of Annex I of Regulation (EC) No 1272/2008.

Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures is marked visibly, legibly and indelibly as follows:

‘Restricted to professional users’.

2. By way of derogation, paragraph 1 shall not apply to:

(a) medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC;

(b) cosmetic products as defined by Directive 76/768/EEC;

(c) the following fuels and oil products:

- motor fuels which are covered by Directive 98/70/EC,

- mineral oil products intended for use as fuel in mobile or fixed combustion plants,

- fuels sold in closed systems (e.g. liquid gas bottles);

(d) artists’ paints covered by Regulation (EC) No 1272/2008; (e) the substances listed in Appendix 11, column 1, for the applications or uses listed in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the derogation shall apply until the said date; (f) devices covered by Regulation (EU) 2017/745.

Appendices referred to in this entry

The appendices are part of Annex XVII in the consolidated text. Appendix titles are quoted as they appear there.

• Appendix 3: Entry 29 - Germ cell mutagens: Category 1 A
• Appendix 4: Entry 29 - Germ cell mutagens: Category 1 B
• Appendix 11: Entries 28 to 30 - Derogations for specific substances

• Consolidated text of REACH on EUR-Lex

Introductory text of Annex XVII

For substances which have been incorporated in this Annex as a consequence of restrictions adopted in the framework of Directive 76/769/EEC (Entries 1 to 58), the restrictions shall not apply to storage, keeping, treatment, filling into containers, or transfer from one container to another of these substances for export, unless the manufacture of the substances is prohibited.

Neighbouring entries

• Entry 28: Substances which are classified as carcinogen category 1A or 1B in Part 3 of Annex VI to ...
• Entry 30: Substances which are classified as reproductive toxicant category 1A or 1B in Part 3 of ...

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