Article 10

By way of derogation from Articles 4 and 5, controlled substances other than hydrochlorofluorocarbons may be produced, placed on the market and used for essential laboratory and analytical uses, subject to registration and licensing in accordance with this Article. The Commission shall, if appropriate, in accordance with the management procedure referred to in Article 25(2), determine any essential laboratory and analytical uses for which the production and import of controlled substances other than hydrochlorofluorocarbons may be permitted in the Community, the respective quantities, the period for which the exemption shall be valid and those users which may take advantage of those essential laboratory and analytical uses. Controlled substances produced or placed on the market for essential laboratory and analytical uses may only be used for that purpose. As of 1 July 2010, containers containing such substances shall be labelled with a clear indication that the substance may only be used for laboratory and analytical uses. Where such substances are required to be labelled in accordance with Directive 67/548/EEC, Directive 1999/45/EC or Regulation (EC) No 1272/2008, such indication shall be included in the label referred to in those Directives or in the supplemental information part of the label as referred to in Article 25(3) of that Regulation. The Commission may determine the form and content of the label to be used. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Controlled substances referred to in the first subparagraph shall only be placed on the market and further distributed under the conditions set out in Annex V. The Commission may amend that Annex. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Any undertaking using controlled substances other than hydrochlorofluorocarbons for essential laboratory and analytical uses shall register with the Commission, indicating the substances being used, the purpose, the estimated annual consumption and the suppliers of those substances, and shall update that information when changes occur. By the date specified in a notice issued by the Commission, producers and importers supplying the undertaking referred to in paragraph 4 or using controlled substances for their own account shall declare to the Commission the foreseen demand for the period specified in the notice, specifying the nature and quantities of controlled substances needed. The Commission shall issue licences to producers and importers of controlled substances, other than hydrochlorofluorocarbons, produced or imported for essential laboratory and analytical uses and shall notify them of the use for which they have authorisation and the substances and quantities thereof that they are authorised to place on the market or to use for their own account. The quantity annually authorised under licences for individual producers and importers shall not exceed 130 % of the annual average of the calculated level of controlled substances licensed for the producer or importer for essential laboratory and analytical uses in the years 2007 to 2009. The total quantity annually authorised under licences, including licences for hydrochlorofluorocarbons under Article 11(2), shall not exceed 110 ODP tonnes. Remaining quantities may be allocated to producers and importers which did not place on the market or use controlled substances, for their own account for essential laboratory and analytical uses in the years 2007 to 2009. The Commission shall determine a mechanism for the allocation of quotas to producers and importers. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). A producer may be authorised by the competent authority of the Member State in which that producer’s relevant production is situated to produce the controlled substances referred to in paragraph 1 for the purpose of meeting the requests licensed in accordance with paragraph 6. The competent authority of the Member State concerned shall notify the Commission in advance of its intention to issue any such authorisation. To the extent permitted by the Protocol, the competent authority of the Member State in which a producer’s relevant production is situated may authorise that producer to produce or to exceed the calculated levels of production laid down in paragraph 6 in order to satisfy any essential laboratory and analytical uses of Parties at their request. The competent authority of the Member State concerned shall notify the Commission in advance of its intention to issue any such authorisation.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-04 · Text as adopted (Official Journal); later amendments are not incorporated in this text.