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1. Refrigeration and air-conditioning equipment, heat pumps and metered dose inhalers pre-charged with substances listed in Section 1 of Annex I shall not be placed on the market unless those substances with which the products or equipment have been pre-charged are accounted for within the quota system referred to in this Chapter. The prohibition set out in the first subparagraph shall apply to such metered dose inhalers from 1 January 2025.

2. When placing on the market pre-charged products or equipment as referred to in paragraph 1, manufacturers and importers of products or equipment shall ensure that compliance with paragraph 1 is fully documented and shall draw up a declaration of conformity in this respect. By drawing up the declaration of conformity, manufacturers and importers of products or equipment shall assume responsibility for compliance with this paragraph and paragraph 1.

Manufacturers and importers of products or equipment shall keep the documentation and the declaration of conformity for a period of at least 5 years from the placing on the market of those products or equipment and shall make them available, upon request, to the competent authority of the Member State concerned or to the Commission.

3. Where hydrofluorocarbons contained in the products or equipment referred to in paragraph 1 have not been placed on the market prior to the charging of the products or equipment, importers of those products or equipment shall ensure that, by 30 April 2025 and every year thereafter, the accuracy of the documentation, the declaration of conformity and the veracity of their report pursuant to Article 26(7) is confirmed, for the preceding calendar year, at a reasonable level of assurance by an independent auditor registered in the F-gas Portal. The independent auditor shall be either:

(a) accredited pursuant to Directive 2003/87/EC of the European Parliament and of the Council (); or (b) accredited to verify financial statements in accordance with the legislation of the Member State concerned.

4. The Commission shall, by means of implementing acts, determine the detailed arrangements relating to the declaration of conformity referred to in paragraph 2, the verification by the independent auditor and the accreditation of auditors. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(2).

5. An importer of products or equipment referred to in paragraph 1, which has no establishment in the Union, shall appoint an only representative with an establishment within the Union that assumes the full responsibility of complying with this Regulation. The only representative may be the same as the one appointed pursuant to Article 8 of Regulation (EC) No 1907/2006.

6. This Article shall not apply to undertakings that placed on the market less than 10 tonnes of CO2 equivalent of hydrofluorocarbons, per year, contained in the products or equipment referred to in paragraph 1.