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О субстанциях, разрушающих озоновый слой (Часть 6)

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REGULATION (EC) No. 1005/2009
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ON SUBSTANCES THAT DEPLETE THE OZONE LAYER (RECAST)

(Strasbourg, 16.IX.2009)

(Text with EEA relevance)

(Amended by
Commission Regulation (EU) No 744/2010 of 18 August 2010,
Commission Regulation (EU) No 1087/2013 of 4 November 2013,
Commission Regulation (EU) No 1088/2013 of 4 November 2013)

The European Parliament and the Council of the European Union,
Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee <*>,
--------------------------------
<*> OJ C 100, 30.4.2009, p. 135.

After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty <*>,
--------------------------------
<*> Opinion of the European Parliament of 25 March 2009 (not yet published in the Official Journal) and Council Decision of 27 July 2009.

Whereas:
(1) Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer <*> has been substantially amended several times. Since further amendments are to be made, it should be recast in the interests of clarity.
--------------------------------
<*> OJ L 244, 29.9.2000, p. 1.

(2) It is established that continued emissions of ozone-depleting substances (ODS) cause significant damage to the ozone layer. There is clear evidence of a decrease in the atmospheric burden of ODS and some early signs of stratospheric ozone recovery have been observed. However, the recovery of the ozone layer to the concentrations level existing before 1980 is not projected to take place before the middle of the 21st century. Increased UV-B radiation resulting from ozone depletion therefore persists as a significant threat to health and environment. At the same time, most of these substances have high global warming potential and are contributory factors towards increasing the temperature of the planet. Further efficient measures need therefore to be taken in order to protect human health and the environment against adverse effects resulting from such emissions and to avoid risking further delay in the recovery of the ozone layer.
(3) In view of its responsibilities for the environment and trade, the Community, pursuant to Council Decision 88/540/EEC <*>, has become a Party to the Vienna Convention for the Protection of the Ozone Layer and the Montreal Protocol on Substances that Deplete the Ozone Layer (hereinafter "the Protocol").
--------------------------------
<*> OJ L 297, 31.10.1988, p. 8.

(4) Many ODS are greenhouse gases but are not controlled under the United Nations Framework Convention for Climate Change and its Kyoto Protocol on the assumption that the Protocol will phase out ODS. Despite progress made by the Protocol, the task of phasing out ODS still needs to be completed in the European Union and globally, whilst bearing in mind that at present many alternatives to ODS have a high global warming potential. It is therefore necessary to minimise and eliminate the production and use of ODS wherever technically feasible alternatives with low global warming potential are available.
(5) Additional measures for the protection of the ozone layer were adopted by the Parties to the Protocol, most recently at their meeting in Montreal in September 2007 and in Doha in November 2008. It is necessary for action to be taken at Community level to comply with the Community's obligations under the Protocol and in particular to implement the accelerated phase out of hydrochlorofluorocarbons with due consideration to the risks of phasing in alternatives with high global warming potential.
(6) Following the concerns stated in the 2006 Report of the Scientific Assessment Panel related to the accelerating growth of production and consumption of hydrochlorofluorocarbons in developing countries, the Parties to the Protocol in 2007 adopted Decision XIX/6 at their 19th Meeting providing for an accelerated phase-out schedule for hydrochlorofluorocarbons. Following that Decision the production phase-out date should be brought forward from 2025 to 2020.
(7) Under Regulation (EC) No 2037/2000, as from 2010, virgin hydrochlorofluorocarbons can no longer be used for the maintenance or servicing of refrigeration and air conditioning equipment. In order to minimise the risk of illegal use of virgin hydrochlorofluorocarbons as recycled or reclaimed material, only reclaimed or recycled material should be used in maintenance or servicing operations. The re-selling of recycled hydrochlorofluorocarbons should be prohibited, and recycled hydrochlorofluorocarbons should only be used when recovered from such equipment and only by the undertaking which carried out or mandated the recovery. For consistency this exemption should also apply to heat pump equipment.
(8) In view of the wide availability of technologies and alternative substances for replacing ODS, it is appropriate in certain cases to provide for control measures which are stricter than those provided for in Regulation (EC) No 2037/2000 and stricter than those in the Protocol.
(9) Under Regulation (EC) No 2037/2000 the production and placing on the market of chlorofluorocarbons, other fully halogenated chlorofluorocarbons, halons, carbon tetrachloride, 1,1,1-trichloroethane, hydrobromofluorocarbons, bromochloromethane and methyl bromide have been phased out and the placing on the market of those substances and of products and equipment containing those substances is thus prohibited. It is now also appropriate to progressively generalise the ban on the use of those substances for the maintenance or servicing of such equipment.
(10) Even after the phase out of controlled substances the Commission should, under certain conditions, grant exemptions for essential laboratory and analytical uses. In particular, Decision X/14 of the Parties to the Protocol establishes criteria for granting of exemptions for those uses. The Commission should be empowered to establish conditions for essential laboratory and analytical uses. To avoid an increase in the quantities used for these purposes, producers and importers should not be allowed to significantly increase the quantities placed on the market. Specific conditions decided by the Parties for the placing on the market of substances for those uses should be integrated into this Regulation to ensure compliance with them.
(11) The availability of alternatives to methyl bromide has been reflected in more substantial reductions in its production and consumption compared to the Protocol, as well as in Commission Decision 2008/753/EC of 18 September 2008 concerning the non-inclusion of methyl bromide in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance <*> and in Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market <**>. The exemption for critical uses of methyl bromide should cease completely whilst temporarily allowing the possibility to grant a derogation in emergency situations in the case of unexpected pests or disease outbreaks where such emergency use is to be permitted under Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market <***> and Directive 98/8/EC. In such cases measures to minimise emissions, such as the use of virtually impermeable films for soil fumigation, should be specified.
--------------------------------
<*> OJ L 258, 26.9.2008, p. 68.
<**> OJ L 123, 24.4.1998, p. 1.
<***> OJ L 230, 19.8.1991, p. 1.

(12) In view of Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market <*>, which banned the use of methyl bromide as a biocide by 1 September 2006, and Decision 2008/753/EC, which banned the use of methyl bromide as a plant protection product by 18 March 2010, the use of methyl bromide for quarantine and pre-shipment applications should also be banned by 18 March 2010.
--------------------------------
<*> OJ L 307, 24.11.2003, p. 1.

(13) The Protocol, in Article 2F(7), requires the Parties to endeavour to ensure that the use of hydrochlorofluorocarbons is limited to those applications where more environmentally suitable alternative substances or technologies are not available. In view of the availability of alternative and substitute technologies, the placing on the market and use of hydrochlorofluorocarbons as well as of products and equipment containing or relying on hydrochlorofluorocarbons can be further limited. Decision VI/13 of the Parties to the Protocol provides that the evaluation of alternatives to hydrochlorofluorocarbons should take into account such factors as ozone-depleting potential, energy efficiency, potential flammability, toxicity, global warming potential and the potential impacts on the effective use and phase out of chlorofluorocarbons and halons. The Parties concluded in that decision that hydrochlorofluorocarbon controls under the Protocol should be considerably tightened to protect the ozone layer and to reflect the availability of alternatives.
(14) Control measures regarding products and equipment containing controlled substances should be extended to products and equipment relying on those substances in order to prevent circumventions of the restrictions under this Regulation. By covering additionally products and equipment for which the design, the use or the proper functioning requires the presence of a controlled substance, a potential opportunity to place on the market, import or export products or equipment which do not contain controlled substances at that moment, but which would have to be refilled at a later date, is eliminated. Furthermore, exemptions for products and equipment manufactured before the entry into force of the control measures should be removed as they are no longer relevant and might constitute a risk of illegal placing on the market or trade.
(15) Controlled substances as well as products and equipment containing or relying on controlled substances from States not party to the Protocol should not be imported. Furthermore, the export of products and equipment containing or relying on hydrochlorofluorocarbons after the entry into force of a ban on use of those products and equipment or of controlled substances for their maintenance or servicing in the Community should be prohibited in order to avoid the building-up of banks of those substances in countries where sufficient destruction facilities are not available.
(16) The licensing system for controlled substances includes the authorisation of exports of controlled substances, in order to improve the monitoring of and control of trade in ODS and to allow for exchange of information between Parties. That licensing system should be extended to products and equipment containing or relying on controlled substances.
(17) To improve the monitoring and control of trade the licensing should cover not only the entry of goods into the customs territory for release for free circulation in the Community but also the entry under other customs procedures or for customs-approved treatments and uses. Transit through the customs territory of the Community, temporary storage, customs warehousing and the free zone procedure should still be possible without licensing in order to avoid unnecessary burdens on operators and customs authorities. Shipments to or from a territory of a Member State that is not part of the customs territory of the Community or not covered by this Regulation, but which is covered by the Member State's ratification of the Protocol should not create unnecessary burdens to Member States in relation to licensing and reporting provided that the obligations of this Regulation and the Protocol are complied with.
(18) Before issuing import and export licences the Commission should be enabled to verify with the competent authorities of the third country concerned whether the intended transaction would comply with the requirements applicable in that country, in order to avoid illegal and unwanted trade.
(19) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances <*>, Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations <**> and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures <***> provide for the labelling of substances classified as ODS and the labelling of mixtures containing such substances. As ODS produced for feedstock, process agent, laboratory and analytical uses can be released for free circulation in the Community, they should be distinguished from those substances produced for other uses, in order to avoid any diversions of controlled substances intended for feedstock, as a process agent or for laboratory and analytical uses to other uses which are controlled under this Regulation. Furthermore, in order to inform end users and to facilitate the enforcement of this Regulation also products and equipment containing or relying on such substances should be so labelled during maintenance or servicing.
--------------------------------
<*> OJ 196, 16.8.1967, p. 1.
<**> OJ L 200, 30.7.1999, p. 1.
<***> OJ L 353, 31.12.2008, p. 1.

(20) To reduce the release of controlled substances into the atmosphere, provision should be made for the recovery of used controlled substances and the prevention of leakages of controlled substances.
(21) The Protocol requires reporting on trade in ODS. Annual reporting should therefore be required from producers, importers and exporters of controlled substances. In order to enable the Commission to streamline the reporting procedures to comply with the Protocol and avoid duplications in the process, destruction facilities should also report directly to the Commission. To ensure compliance with reporting obligations under the Protocol and to improve their practical application the Commission should be empowered to modify the reporting requirements for Member States and undertakings. In view of the envisaged development of Internet-based reporting tools the Commission should, as appropriate, draft measures to adapt the reporting requirements as soon as the relevant reporting tools are in place.
(22) The protection of individuals with regard to the processing of personal data by the Member States is governed by Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data <*> and the protection of individuals with regard to the processing of personal data by the Commission is governed by Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data <**> in particular as regards the requirements of confidentiality and security of processing, the transfer of personal data from the Commission to the Member States, the lawfulness of processing, and the rights of data subjects to information, access to and rectification of their personal data.
--------------------------------
<*> OJ L 281, 23.11.1995, p. 31.
<**> OJ L 8, 12.1.2001, p. 1.

(23) Member States should carry out inspections, taking a risk-based approach in order to ensure compliance with all provisions of this Regulation and thus targeting those activities representing the highest risk of illegal trade or emission of controlled substances. Recommendation 2001/331/EC of the European Parliament and of the Council of 4 April 2001 providing for minimum criteria for environmental inspections in the Member States <*> should provide guidance for the carrying out of inspections by Member States.
--------------------------------
<*> OJ L 118, 27.4.2001, p. 41.

(24) In view of the continuing innovation in the sectors covered by this Regulation, the Commission should regularly review this Regulation and, if appropriate, make proposals, in particular on the exemptions and derogations provided for when technically and economically feasible alternatives to the use of controlled substances become available, to further strengthen the protection of the ozone layer and simultaneously reduce greenhouse gases emissions. In order to ensure compliance with the Protocol, the Commission should be empowered to align Annexes to this Regulation with decisions of the Parties, in particular with those concerning approved destruction methods, conditions for the placing on the market of controlled substances for essential laboratory and analytical uses, and processes in which controlled substances may be used as process agents.
(25) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission <*>.
--------------------------------
<*> OJ L 184, 17.7.1999, p. 23.

(26) In particular, the Commission should be empowered to determine the form and content of labels for controlled substances produced, placed on the market or used as feedstock, as process agent or for laboratory and analytical uses; to amend Annex III on processes for which controlled substances may be used as process agents; to amend the maximum amount of controlled substances that may be used as process agents or emitted from process agents uses; to amend Annex V on conditions for placing on the market and further distribution of controlled substances for laboratory and analytical uses; to determine a mechanism for the allocation of quotas for controlled substances for laboratory and analytical uses; to amend Annex VI; to adopt modifications and time frames for the phasing out of the critical uses of halons; to amend the list of items required to be stated in an application for a licence; to adopt additional monitoring measures on trade in controlled substances or new substances and of products and equipment containing or relying on controlled substances; to adopt rules applicable to the release for free circulation in the Community of products and equipment imported from any State not party to the Protocol which were produced using controlled substances; to amend Annex VII on destruction technologies; to establish a list with products and equipment for which the recovery for destruction or destruction without prior recovery of controlled substances should be considered technically and economically feasible and therefore mandatory; to adopt minimum qualification requirements for personnel; to establish a list of technologies and practices to be used by undertakings to prevent and minimise any leakage and emission of controlled substances; to include new substances in Annex II and to amend reporting requirements for Member States and undertakings. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(27) Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste <*> and Council Directive 91/689/EEC of 12 December 1991 on hazardous waste <**> provide for measures on the environmentally sound disposal and recovery of waste and controls on hazardous waste. In this regard, special attention should be paid to ODS in construction and demolition waste and in equipment falling within the scope of Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and electronic equipment (WEEE) <***>. In accordance with the Protocol only technologies approved by the Parties may be applied to the destruction of controlled substances. The relevant decisions of the Parties should therefore be incorporated in this Regulation to ensure that only those technologies are applied, provided that their application is compatible with Community and national legislation on waste.
--------------------------------
<*> OJ L 114, 27.4.2006, p. 9. Directive 2006/12/EC is repealed by Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3) with effect from 12 December 2010.
<**> OJ L 377, 31.12.1991, p. 20.
<***> OJ L 37, 13.2.2003, p. 24.

(28) A flexible mechanism should be established to introduce reporting obligations for substances identified as ozone depleting, to allow for assessing the magnitude of their environmental impact and to ensure that those new substances which have been identified as having a significant ozone-depleting potential are subject to control measures. In this context, special attention should be paid to the role of very short-lived substances, having regard, in particular, to the 2006 United Nations Environment Programme/World Meteorological Organisation (UNEP/WMO) ozone assessment, which concluded that the ozone-depleting potential of those substances is greater than previously assessed.
(29) Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.
(30) Since the objectives of this Regulation, namely to ensure compliance with the Community's obligations as party to the Protocol and to address a transboundary environmental problem with global impact whilst regulating intra-Community and external trade in ODS and products and equipment containing or relying on those substances, cannot be sufficiently achieved by the Member States acting individually and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,
Have adopted this Regulation:

 

Chapter I. GENERAL PROVISIONS

Article 1

Subject matter

This Regulation lays down rules on the production, import, export, placing on the market, use, recovery, recycling, reclamation and destruction of substances that deplete the ozone layer, on the reporting of information related to those substances and on the import, export, placing on the market and use of products and equipment containing or relying on those substances.

Article 2

Scope

This Regulation shall apply to controlled substances, to new substances and to products and equipment containing or relying on controlled substances.

Article 3

Definitions

For the purposes of this Regulation:
1. "Protocol" means the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer, as last amended and adjusted;
2. "Party" means any party to the Protocol;
3. "State not party to the Protocol" means, with respect to a particular controlled substance, any State or regional economic integration organisation that has not agreed to be bound by the provisions of the Protocol applicable to that substance;
4. "controlled substances" means substances listed in Annex I, including their isomers, whether alone or in a mixture, and whether they are virgin, recovered, recycled or reclaimed;
5. "chlorofluorocarbons" means the controlled substances listed in Group I of Annex I, including their isomers;
6. "halons" means the controlled substances listed in Group III of Annex I, including their isomers;
7. "carbon tetrachloride" means the controlled substance specified in Group IV of Annex I;
8. "methyl bromide" means the controlled substance specified in Group VI of Annex I;
9. "hydrochlorofluorocarbons" means the controlled substances listed in Group VIII of Annex I, including their isomers;
10. "new substances" means substances listed in Annex II, whether alone or in a mixture, and whether they are virgin, recovered, recycled or reclaimed;
11. "feedstock" means any controlled substance or new substance that undergoes chemical transformation in a process in which it is entirely converted from its original composition and whose emissions are insignificant;
12. "process agents" means controlled substances used as chemical process agents in the applications listed in Annex III;
13. "producer" means any natural or legal person producing controlled substances or new substances within the Community;
14. "production" means the amount of controlled substances or new substances produced, including the amount produced, intentionally or inadvertently, as a by-product unless that by-product is destroyed as part of the manufacturing process or following a documented procedure ensuring compliance with this Regulation and the Community and national legislation on waste. No amount recovered, recycled or reclaimed shall be considered as "production", nor shall any insignificant amount unavoidably incorporated in products in trace quantities or emitted during manufacturing;
15. "ozone-depleting potential" or 'ODP' means the figure specified in Annexes I and II representing the potential effect of each controlled substance or new substance on the ozone layer;
16. "calculated level" means a quantity determined by multiplying the quantity of each controlled substance by its ozone-depleting potential and by adding together, for each group of controlled substances in Annex I separately, the resulting figures;
17. "industrial rationalisation" means the transfer either between Parties or within a Member State of all or a portion of the calculated level of production of one producer to another, for the purpose of optimising economic efficiency or responding to anticipated shortfalls in supply as a result of plant closures;
18. "import" means the entry of substances, products and equipment covered by this Regulation into the customs territory of the Community as far as the territory is covered by a Member State's ratification of the Protocol and this Regulation applies;
19. "export" means the exit from the customs territory of the Community, in so far as the territory is covered by a Member State's ratification of the Protocol and by this Regulation, of substances, products and equipment covered by this Regulation which have the status of Community goods or the re-export of substances, products and equipment covered by this Regulation if they have the status of non-Community goods;
20. "placing on the market" means the supplying or making available to third persons within the Community for payment or free of charge, and includes the release for free circulation in the Community as referred to in Regulation (EC) No 450/2008. In respect of products and equipment being part of immovable property or part of means of transport this refers only to the supplying or making available within the Community for the first time;
21. "use" means the utilisation of controlled substances or new substances in the production, maintenance or servicing, including refilling, of products and equipment or in other processes;
22. "heat pump" means a device or installation that extracts heat at low temperatures from air, water or earth and supplies heat;
23. "recovery" means the collection and the storage of controlled substances from products and equipment or containers during maintenance or servicing or before disposal;
24. "recycling" means the reuse of a recovered controlled substance following a basic cleaning process;
25. "reclamation" means the reprocessing of a recovered controlled substance in order to meet the equivalent performance of a virgin substance, taking into account its intended use;
26. "undertaking" means any natural or legal person which:
(a) produces, recovers, recycles, reclaims, uses or destroys controlled substances or new substances;
(b) imports such substances;
(c) exports such substances;
(d) places such substances on the market; or
(e) operates refrigeration, air conditioning or heat pump equipment, or fire protection systems, which contain controlled substances;
27. "quarantine applications" means treatments to prevent the introduction, establishment or spread of quarantine pests (including diseases), or to ensure their official control, where:
- official control is that performed by, or authorised by, a national plant, animal or environmental protection or health authority,
- quarantine pests are pests of potential importance to the areas endangered thereby and not yet present there, or present but not widely distributed, and being officially controlled;
28. "pre-shipment applications" means those non-quarantine applications applied no more than 21 days prior to export to meet the official requirements of the importing country or official requirements of the exporting country existing before 7 December 1995. Official requirements are those which are performed by, or authorised by, a national plant, animal, environmental, health or stored product authority;
29. "products and equipment relying on controlled substances" means products and equipment which do not function without controlled substances, not including those products and equipment used for the production, processing, recovery, recycling, reclamation or destruction of controlled substances;
30. "virgin substances" means substances which have not previously been used;
31. "products and equipment" means all products and equipment except containers used for the transportation or storage of controlled substances.

 

Chapter II. PROHIBITIONS

Article 4

Production of controlled substances

The production of controlled substances shall be prohibited.

Article 5

Placing on the market and use of controlled substances

1. The placing on the market and the use of controlled substances shall be prohibited.
2. Controlled substances shall not be placed on the market in non-refillable containers, except for laboratory and analytical uses as referred to in Article 10 and Article 11(2).
3. This Article shall not apply to controlled substances in products and equipment.

Article 6

Placing on the market of products and equipment containing or relying on controlled substances

1. The placing on the market of products and equipment containing or relying on controlled substances shall be prohibited, with the exception of products and equipment for which the use of the respective controlled substance is authorised in accordance with Article 10, Article 11 (2) or Article 13 or has been authorised on the basis of Article 3(1) of Regulation (EC) No 2037/2000.
2. Except for uses referred to in Article 13(1), fire protection systems and fire extinguishers containing halons shall be prohibited and shall be decommissioned.

 

Chapter III. EXEMPTIONS AND DEROGATIONS

Article 7

Production, placing on the market and use of controlled substances as feedstock

1. By way of derogation from Articles 4 and 5, controlled substances may be produced, placed on the market and used as feedstock.
2. Controlled substances produced or placed on the market as feedstock may only be used for that purpose. As of 1 July 2010, containers of such substances shall be labelled with a clear indication that the substance may only be used as feedstock. 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, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3).

Article 8

Production, placing on the market and use of controlled substances as process agents

1. By way of derogation from Articles 4 and 5, controlled substances may be produced, placed on the market and used as process agents.
2. Controlled substances may only be used as process agents in installations existing on 1 September 1997, and where emissions are insignificant.
3. Controlled substances produced or placed on the market as process agents may only be used for that purpose. As of 1 July 2010, containers of such substances shall be labelled with a clear indication that those substances may only be used as process agents. 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, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3).
4. The Commission shall, if appropriate, in accordance with the management procedure referred to in Article 25(2), establish a list of undertakings in which the use of controlled substances as process agents shall be permitted, laying down maximum quantities that may be used for make-up or for consumption as process agents and emission levels for each of the undertakings concerned.
The maximum amount of controlled substances that may be used as process agents within the Community shall not exceed 1 083 metric tonnes per year.
The maximum amount of controlled substances that may be emitted from process agent uses within the Community shall not exceed 17 metric tonnes per year.
5. In the light of new information or technical developments or decisions taken by the Parties, the Commission shall, if appropriate:
(a) amend Annex III;
(b) amend the maximum amount of controlled substances that may be used as process agents or emitted from process agent uses as referred to in the second and third subparagraphs of paragraph 4.
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).

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