31.10.1988 EN Official Journal of the European Communities L 297/21 MONTREAL PROTOCOL ON SUBSTANCES THAT DEPLETE THE OZONE LAYER THE PARTIES TO THIS PROTOCOL, BEING Parties to the Vienna Convention for the protection of the ozone layer, MINDFUL of their obligations under that Convention to take appropriate measures to protect human health and the environment against adverse effects resulting or likely to result from human activities which modify or are likely to modify the ozone layer, RECOGNIZING that world-wide emissions of certain substances can significantly deplete and otherwise modify the ozone layer in a manner that is likely to result in adverse effects on human health and the environment, CONSCIOUS of the potential climatic effects of emissions of these substances, AWARE that measures taken to protect the ozone layer from depletion should be based on relevant scientific knowledge, taking into account technical and economic considerations, DETERMINED to protect the ozone layer by taking precautionary measures to control equitably total global emissions of substances that deplete it, with the ultimate objective of their elimination on the basis of developments in scientific knowledge, taking into account technical and economic considerations, ACKNOWLEDGING that special provision is required to meet the needs of developing countries for these substances, NOTING the precautionary measures for controlling emissions of certain chlorofluorocarbons that have already been taken at national and regional levels, CONSIDERING the importance of promoting international cooperation in the research and development of science and technology relating to the control and reduction of emissions of substances that deplete the ozone layer, bearing in mind in particular the needs of developing countries, HAVE AGREED AS FOLLOWS: Article 1 Definitions For the purposes of this Protocol: 1. ‘Convention’ means the Vienna Convention for the protection of the ozone layer, adopted on 22 March 1985. 2. ‘Parties’ means, unless the text indicates, Parties to this Protocol. 3. ‘Secretariat’ means the secretariat of the Convention. 4. ‘Controlled substance’ means a substance listed in Annex A to this Protocol, whether existing alone or in a mixture. It excludes, however, any such substance or mixture which is in a manufactured product other than a container used for the transportation or storage of the substance listed. 5. ‘Production’ means the amount of controlled substances produced minus the amount destroyed by technologies to be approved by the Parties. 6. ‘Consumption’ means production plus imports minus exports of controlled substances. 7. ‘Calculated levels’ of production, imports, exports and consumption means levels determined in accordance with Article 3. 8. ‘Industrial rationalization’ means the transfer of all or a portion of the calculated level of production of one Party to another, for the purpose of achieving economic efficiencies or responding to anticipated shortfalls in supply as a result of plant closures. Article 2 Control measures 1. Each Party shall ensure that for the 12-month period commencing on the first day of the seventh month following the date of the entry into force of this Protocol, and in each 12-month period thereafter, its calculated level of consumption of the controlled substances in Group I of Annex A does not exceed its calculated level of consumption in 1986. By the end of the same period, each Party producing one or more of these substances shall ensure that its calculated level of production of the substances does not exceed its calculated level of production in 1986, except that such level may have increased by no more than 10 % based on the 1986 level. Such increase shall be permitted only so as to satisfy the basic domestic needs of the Parties operating under Article 5 and for the purposes of industrial rationalization between Parties. 2. Each Party shall ensure that for the 12-month period commencing on the first day of the 37th month following the date of the entry into force of this Protocol, and in each 12-month period thereafter, its calculated level of consumption of the controlled substances listed in Group II of Annex A does not exceed its calculated level of consumption in 1986. Each Party producing one or more of these substances shall ensure that its calculated level of production of the substances does not exceed its calculated level of production in 1986, except that such level may have increased by no more than 10% based on the 1986 level. Such increase shall be permitted only so as to satisfy the basic domestic needs of the Parties operating under Article 5 and for the purposes of industrial rationalization between Parties. The mechanisms for implementing these measures shall be decided by the Parties at their first meeting following the first scientific review. 3. Each Party shall ensure that for the period 1 July 1993 to 30 June 1994 and in each 12-month period thereafter, its calculated level of consumption of the controlled substances in Group I of Annex A does not exceed, annually, 80 % of its calculated level of consumption in 1986. Each Party producing one or more of these substances shall, for the same periods, ensure that its calculated level of production of the substances does not exceed, annually, 80 % of its calculated level of production in 1986. However, in order to satisfy the basic domestic needs of the Parties operating under Article 5 and for the purposes of industrial rationalization between Parties, its calculated level of production may exceed that limit by up to 10 % of its calculated level of production in 1986. 4. Each Party shall ensure that for the period 1 July 1998 to 30 June 1999, and in each 12-month period thereafter, its calculated level of consumption of the controlled substances in Group I of Annex A does not exceed, annually, 50 % of its calculated level of consumption in 1986. Each Party producing one or more of these substances shall, for the same periods, ensure that its calculated level of production of the substances does not exceed, annually, 50 % of its calculated level of production in 1986. However, in order to satisfy the basic domestic needs of the Parties operating under Article 5 and for the purposes of industrial rationalization between Parties, its calculated level of production may exceed that limit by up to 15 % of its calculated level of production in 1986. This paragraph will apply unless the Parties decide otherwise at a meeting by a two-thirds majority of Parties present and voting, representing at least two-thirds of the total calculated level of consumption of these substances of the Parties. This decision shall be considered and made in the light of the assessments referred to in Article 6. 5. Any Party whose calculated level of production in 1986 of the controlled substances in Group I of Annex A was less than 25 kilotonnes may, for the purposes of industrial rationalization, transfer to or receive from any other Party, production in excess of the limits set out in paragraphs 1, 3 and 4 provided that the total combined calculated levels of production of the Parties concerned does not exceed the production limits set out in this Article. Any transfer of such production shall be notified to the secretariat, no later than the time of the transfer. 6. Any Party not operating under Article 5, that has facilities for the production of controlled substances under construction, or contracted for, prior to 16 September 1987, and provided for in national legislation prior to 1 January 1987, may add the production from such facilities to its 1986 production of such substances for the purposes of determining its calculated level of production for 1986, provided that such facilities are completed by 31 December 1990 and that such production does not raise that Party's annual calculated level of consumption of the controlled substances above 0,5 kilograms per capita. 7. Any transfer of production pursuant to paragraph 5 or any addition of production pursuant to paragraph 6 shall be notified to the secretariat, no later than the time of the transfer or addition. 8. (a) Any Parties which are Member States of a regional economic integration organization as defined in Article 1 (6) of the Convention may agree that they shall jointly fulfil their obligations respecting consumption under this Article provided that their total combined calculated level of consumption does not exceed the levels required by this Article. (b) The Parties to any such agreement shall inform the secretariat of the terms of the agreement before the date of the reduction in consumption with which the agreement is concerned. (c) Such agreement will become operative only if all Member States of the regional economic integration organization and the organization concerned are Parties to the Protocol and have notified the secretariat of their manner of implementation. 9. (a) Based on the assessment made pursuant to Article 6, the Parties may decide whether: (i) adjustments to the ozone-depleting potentials specified in Annex A should be made and, if so, what the adjustments should be; and (ii) further adjustments and reductions of production or consumption of the controlled substances from 1986 levels should be undertaken and, if so, what the scope, amount and timing of any such adjustment and reductions should be. (b) Proposals for such adjustments shall be communicated to the Parties by the secretariat at least six month before the meeting of the Parties at which they are proposed for adoption. (c) In taking such decisions, the Parties shall make every effort to reach agreement by consensus. If all efforts at consensus have been exhausted, and no agreement reached, such decisions shall, as a last resort, be adopted by a two-thirds majority vote of the Parties present and voting representing at least 50 % of the total consumption of the controlled substances of the Parties. (d) The decisions, which shall be binding on all Parties, shall forthwith be communicated to the Parties by the Depositary. Unless otherwise provided in the decisions, they shall enter into force on the expiry of six months from the date of the circulation of the communication by the Depositary. 10. (a) Based on the assessment made pursuant to Article 6 of this Protocol and in accordance with the procedure set out in Article 9 of the Convention, the Parties may decide: (i) whether any substances, and if so which, should be added to or removed from any annex to this Protocol; and (ii) the mechanism, scope and timing of the control measures that should apply to those substances. (b) Any such decision shall become effective, provided that it has been accepted by a two-thirds majority vote of the Parties present and voting. 11. Notwithstanding the provisions contained in this Article, Parties may take more stringent measures than those required by this Article. Article 3 Calculation of control levels For the purposes of Articles 2 and 5, each Party shall, for each group of substances in Annex A, determine its calculated levels of: (a) production by: (i) multiplying its annual production of each controlled substance by the ozone-depleting potential specified in respect of it in Annex A; and (ii) adding together, for each such group, the resulting figures; (b) imports and exports, respectively, by following, mutatis mutandis, the procedure set out in subparagraph (a); and (c) consumption by adding together its calculated levels of production and imports and subtracting its calculated level of exports as determined in accordance with subparagraphs (a) and (b). However, beginning on 1 January 1993, any export of controlled substances to non-parties shall not be subtracted in calculating the consumption level of the exporting Party. Article 4 Control of trade with non-parties 1. Within one year of the entry into force of this Protocol, each Party shall ban the import of controlled substances from any State not party to this Protocol. 2. Beginning on 1 January 1993, no Party operating under paragraph 1 of Article 5 may export any controlled substance to any State not party to this Protocol. 3. Within three years of the date of the entry into force of this Protocol, the Parties shall, following the procedures in Article 10 of the Convention, elaborate in an annex a list of products containing controlled substances. Parties that have not objected to the annex in accordance with those procedures shall ban, within one year of the annex having become effective, the import of those products from any State not party to this Protocol. 4. Within five years of the entry into force of this Protocol, the Parties shall determine the feasibility of banning or restricting, from States not party to this Protocol, the import of products produced with, but not containing, controlled substances. If determined feasible, the Parties shall, following the procedures in Article 10 of the Convention, elaborate in an annex a list of such products. Parties that have not objected to it in accordance with those procedures shall ban or restrict, within one year of the annex having become effective the import of those products from any State not party to this Protocol. 5. Each Party shall discourage the export, to any State not party to this Protocol, of technology for producing and for utilizing controlled substances. 6. Each Party shall refrain from providing new subsidies, aid, credits, guarantees or insurance programmes for the export to States not party to this Protocol of products, equipment, plants or technology that would facilitate the production of controlled substances. 7. Paragraphs 5 and 6 shall not apply to products, equipment, plants or technology that improve the containment, recovery, recycling or destruction of controlled substances, promote the development of alternative substances, or otherwise contribute to the reduction of emissions of controlled substances. 8. Notwithstanding the provisions of this Article, imports referred to in paragraphs 1, 3 and 4 may be permitted from any State not party to this Protocol if that State is determined, by a meeting of the Parties, to be in full compliance with Article 2 and this Article, and has submitted data to that effect as specified in Article 7. Article 5 Special situation of developing countries 1. Any Party that is a developing country and whose annual calculated level of consumption of the controlled substances is less than 0,3 kilograms per capita on the date of the entry into force of the Protocol for it, or any time thereafter within 10 years of the date of entry into force of the Protocol shall, in order to meet its basic domestic needs, be entitled to delay its compliance with the control measures set out in paragraphs 1 to 4 of Article 2 by 10 years after that specified in those paragraphs. However, such Party shall not exceed an annual calculated level of consumption of 0,3 kilograms per capita. Any such Party shall be entitled to use either the average of its annual calculated level of consumption for the period 1995 to 1997 inclusive or a calculated level of consumption of 0,3 kilograms per capita, whichever is the lower, as the basis for its compliance with the control measures. 2. The Parties undertake to facilitate access to environmentally safe alternative substances and technology for Parties that are developing countries and assist them to make expeditious use of such alternatives. 3. The Parties undertake to facilitate bilaterally or multilaterally the provision of subsidies, aid, credits, guarantees or insurance programmes to Parties that are developing countries for the use of alternative technology and for substitute products. Article 6 Assessment and review of control measures Beginning in 1990, and at least every four years thereafter, the Parties shall assess the control measures provided for in Article 2 on the basis of available scientific, environmental, technical and economic information. At least one year before each assessment, the Parties shall convene appropriate panels of experts qualified in the fields mentioned and determine the composition and terms of reference of any such panels. Within one year of being convened, the panels will report their conclusions, through the secretariat, to the Parties. Article 7 Reporting of data 1. Each Party shall provide to the secretariat, within three months of becoming a Party, statistical data on its production, imports and exports of each of the controlled substances for the year 1986, or the best possible estimates of such data where actual data are not available. 2. Each Party shall provide statistical data to the secretariat on its annual production (with separate data on amounts destroyed by technologies to be approved by the Parties), imports, and exports to Parties and non-parties, respectively, of such substances for the year during which it becomes a Party and for each year thereafter. It shall forward the data no later than nine months after the end of the year to which the data relate. Article 8 Non-compliance The Parties, at their first meeting, shall consider and approve procedures and institutional mechanisms for determining non-compliance with the provisions of this Protocol and for treatment of Parties found to be in non-compliance. Article 9 Research, development, public awareness and exchange of information 1. The Parties shall cooperate, consistent with their national laws, regulations and practices and taking into account in particular the needs of developing countries, in promoting, directly or through competent international bodies, research, development and exchange of information on: (a) best technologies for improving the containment, recovery, recycling or destruction of controlled substances or otherwise reducing their emissions; (b) possible alternatives to controlled substances, to products containing such substances, and to products manufactured with them; and (c) costs and benefits of relevant control strategies. 2. The Parties, individually, jointly or through competent international bodies, shall cooperate in promoting public awareness of the environmental effects of the emissions of controlled substances and other substances that deplete the ozone layer. 3. Within two years of the entry into force of this Protocol and every two years thereafter, each Party shall submit to the secretariat a summary of the activities it has conducted pursuant to this Article Article 10 Technical assistance 1. The Parties shall, in the context of the provisions of Article 4 of the Convention, and taking into account in particular the needs of developing countries, cooperate in promoting technical assistance to facilitate participation in and implementation of this Protocol. 2. Any Party or Signatory to this Protocol may submit a request to the secretariat for technical assistance for the purposes of implementing or participating in the Protocol. 3. The Parties, at their first meeting, shall begin deliberations on the means of fulfilling the obligations set out in Article 9, and paragraphs 1 and 2 of this Article, including the preparation of workplans. Such workplans shall pay special attention to the needs and circumstances of the developing countries. States and regional economic integration organizations not party to the Protocol should be encouraged to participate in activities specified in such workplans. Article 11 Meetings of the Parties 1. The Parties shall hold meetings at regular intervals. The secretariat shall convene the first meeting of the Parties not later than one year after the date of the entry into force of this Protocol and in conjunction with a meeting of the Conference of the Parties to the Convention, if a meeting of the latter is scheduled within that period. 2. Subsequent ordinary meetings of the Parties shall be held, unless the Parties otherwise decide, in conjunction with meetings of the Conference of the Parties to the Convention. Extraordinary meetings of the Parties shall be held at such other times as may be deemed necessary by a meeting of the Parties, or at the written request of any Party, provided that, within six months of such a request being communicated to them by the secretariat, it is supported by at least one-third of the Parties. 3. The Parties, at their first meeting, shall: (a) adopt by consensus rules of procedure for their meetings; (b) adopt by consensus the financial rules referred to in paragraph 2 of Article 13; (c) establish the panels and determine the terms of reference referred to in Article 6; (d) consider and approve the procedures and institutional mechanisms specified in Article 8; and (e) begin preparation of workplans pursuant to paragraph 3 of Article 10. 4. The functions of the meetings of the Parties shall be to: (a) review the implementation of this Protocol; (b) decide on any adjustments or reductions referred to in paragraph 9 of Article 2; (c) decide on any addition to, insertion in or removal from any annex of substances and on related control measures in accordance with paragraph 10 of Article 2; (d) establish, where necessary, guidelines or procedures for reporting of information as provided for in Article 7 and paragraph 3 of Article 9; (e) review requests for technical assistance submitted pursuant to paragraph 2 of Article 10; (f) review reports prepared by the secretariat pursuant to subparagraph (c) of Article 12; (g) assess, in accordance with Article 6, the control measures provided for in Article 2; (h) consider and adopt, as required, proposals for amendment of this Protocol or any annex and for any new annex; (i) consider and adopt the budget for implementing this Protocol; and (j) consider and undertake any additional action that may be required for the achievement of the purposes of this Protocol. 5. The United Nations, its specialized agencies and the International Atomic Energy Agency, as well as any State not party to this Protocol, may be represented at meetings of the Parties as observers. Any body or agency, whether national or international, governmental or non-governmental, qualified in fields relating to the protection of the ozone layer which has informed the secretariat of its wish to be represented at a meeting of the Parties as an observer may be admitted unless at least one-third of the Parties present object. The admission and participation of observers shall be subject to the rules of procedure adopted by the Parties. Article 12 Secretariat For the purposes of this Protocol, the secretariat shall: (a) arrange for and service meetings of the Parties as provided for in Article 11; (b) receive and make available, upon request by a Party, data provided pursuant to Article 7; (c) prepare and distribute regularly to the Parties reports based on information received pursuant to Articles 7 and 9; (d) notify the Parties of any request for technical assistance received pursuant to Article 10 so as to facilitate the provision of such assistance; (e) encourage non-parties to attend the meetings of the Parties as observers and to act in accordance with the provisions of this Protocol; (f) provide, as appropriate, the information and requests referred to in subparagraphs (c) and (d) to such non-party observers; and (g) perform such other functions for the achievement of the purposes of this Protocol as may be assigned to it by the Parties. Article 13 Financial Provisions 1. The funds required for the operation of this Protocol, including those for the functioning of the secretariat related to this Protocol, shall be charged exclusivly against contributions from the Parties. 2. The Parties, at their first meeting, shall adopt by consensus financial rules for the operation of this Protocol Article 14 Relationship of this Protocol to the Convention Except as otherwise provided in this Protocol, the provisions of the Convention relating to its protocols shall apply to this Protocol. Article 15 Signature This Protocol shall be open for signature by States and by regional economic integration organizations in Montreal on 16 September 1987, in Ottawa from 17 September 1987 to 16 January 1988, and at United Nations Headquarters in New York from 17 January 1988 to 15 September 1988. Article 16 Entry into force 1. This Protocol shall enter into force on 1 January 1989, provided that at least 11 instruments of ratification, acceptance, approval of the Protocol or accession thereto have been deposited by States or regional economic integration organizations representing at least two-thirds of 1986 estimated global consumption of the controlled substances, and the provisions of paragraph 1 of Article 17 of the Convention have been fulfilled. In the event that these conditions have not been fulfilled by that date, the Protocol shall enter into force on the 90th day following the date on which the conditions have been fulfilled. 2. For the purposes of paragraph 1, any such instrument deposited by a regional economic integration organization shall not be counted as additional to those deposited by member States of such organization. 3. After the entry into force of this Protocol, any State or regional economic integration organization shall become a Party to it on the 90th day following the date of deposit of its instrument of ratification, acceptance, approval or accession. Article 17 Parties joining after entry into force Subject to Article 5, any State or regional economic integration organization which becomes a Party to this Protocol after the date of its entry into force, shall fulfil forthwith the sum of the obligations under Article 2, as well as under Article 4, that apply at that date to the States and regional economic integration organizations that became Parties on the date the Protocol entered into force. Article 18 Reservations No reservations may be made to this Protocol. Article 19 Withdrawal For the purpose of this Protocol, the provisions of Articles 19 of the Convention relating to withdrawal shall apply, except with respect to Parties referred to in paragraph 1 of Article 5. Any such Party may withdraw from this Protocol by giving written notification to the Depositary at any time after four years of assuming the obligations specified in paragraphs 1 to 4 of Article 2. Any such withdrawal shall take effect upon expiry of one year after the date of its receipt by the Depositary, or on such later date as may be specified in the notification of the withdrawal. Article 20 Authentic texts The original of this Protocol, of which the Arabic, Chinese, English, French, Russian and Spanish texts are equally authentic, shall be deposited with the Secretary-General of the United Nations. In witness whereof the undersigned, being duly authorized to that effect, have signed this protocol. Done at Montreal this sixteenth day of September, one thousand nine hundred and eighty-seven. Annex A CONTROLLED SUBSTANCES Group Substance Ozone-depleting potential (1) Group I CFC13 (CFC-11) 1,0 CF2C12 (CFC-12) 1,0 C2F3Cl3 (CFC-113) 0,8 C2F4Cl2 (CFC-114) 1,0 C2F5C1 (CFC-115) 0,6 Group II CF2BrCl (halon-1211) 3,0 CF3Br (halon-1301) 10,0 C2F4Br2 (halon-2402) (to be determined) (1) These ozone-depleting potentials are estimates based on existing knowledge and will be reviewed and revised periodically. ANNEX II Declaration by the European Economic Community in conformity with Article 13 (3) of the Vienna Convention for the protection of the ozone layer concerning the extent of its competence with respect to the matters covered by the Convention and by the Montreal Protocol on substances that deplete the ozone layer In accordance with the relevant Articles of the EEC Treaty, the Community has competence to take action relating to the preservation, protection and improvement of the quality of the environment. The Community has exercised its competence in the area covered by the Vienna Convention and the Montreal Protocol in adopting Council Decision 80/372/EEC of 26 March 1980 concerning chlorofluorocarbons in the environment (1), Council Decision 82/795/EEC of 15 November 1982 on the consolidation of precautionary measures concerning chlorofluorocarbons in the environment (2) and Council Regulation (EEC) No 3322/88 of 14 October 1988 on certain chlorofluorocarbons and halons which deplete the ozone layer (3). The Community may well exercise its competence in the future by adopting further legislation in this area. In the field of research in the environment, as referred to by the Convention, the Community has a certain competence by virtue of Council Decision 86/234/EEC of 10 June 1986 adopting multiannual R&D programmes in the field of the environment (1986 to 1990). (1) OJ No L 90, 3. 4. 1980, p. 45. (2) OJ No L 329, 25. 11. 1982, p. 29. (3) See page 1 of this Official Journal.

Summary: Montreal Protocol on substances that deplete the ozone layer Montreal Protocol on substances that deplete the ozone layer SUMMARY OF: Montreal Protocol on substances that deplete the ozone layer Decision 88/540/EEC on the conclusion of the Vienna Convention for the protection of the ozone layer and the Montreal Protocol on substances that deplete the ozone layer WHAT IS THE AIM OF THE PROTOCOL AND THE DECISION? The Montreal Protocol (to the Vienna Convention for the protection of the ozone layer) is a global agreement to protect the earth’s stratospheric ozone layer by phasing out the chemicals that deplete it. This phase-out includes both the production and consumption of ozone-depleting substances (ODSs). Because ODSs are also potent greenhouse gases, the phase-out is also critical to mitigating climate change. Moreover, despite the fact that hydrofluorocarbons (HFCs) do not deplete the ozone, the protocol seeks to phase down their production and consumption to avoid that ODSs are replaced by the HFCs which contribute significantly to climate change. The Montreal Protocol was agreed in 1987 and entered into force in 1989. It has been amended several times. Its most recent amendment, the Kigali Amendment calls for the gradual phase-down of HFCs. Emissions from HFCs are covered by the Paris Agreement, approved by Decision (EU) 2016/1841. Thus the Montreal Protocol helps to meet the objective of keeping the global temperature increase well below 2 °C above pre-industrial levels and to pursue efforts to limit the temperature increase even further to 1.5 °C above pre-industrial levels. Decision 88/540/EEC gives the EU’s legal approval for the Vienna Convention for the protection of the ozone layer and the Montreal Protocol on substances that deplete the ozone layer, as adopted by its Parties on 15 September 1987. KEY POINTS The EU and the EU countries are Parties to the Vienna Convention and its Montreal Protocol. The Protocol includes provisions relating to: control measures (Article 2)calculation of control levels (Article 3)control of trade with non-Parties (Article 4)the special situation of developing countries (Article 5)reporting of data (Article 7)non-compliance (Article 8)financial mechanismtechnical assistance (Article 10), as well as other topics. The substances controlled are listed in Annexes: A (Chlorofluorocarbons — CFCs, halons), B (other fully halogenated CFCs, carbon tetrachloride, methyl chloroform), C (hydrochlorofluorocarbons — HCFCs, hydrobromofluorocarbons — HBFCs and bromochloromethane), E (methyl bromide) and F (HFCs). The Montreal Protocol envisages a phase-out of the consumption and production of the ozone-depleting substances and a phase-down of HFCs in a step-wise manner. There are different timetables for developing countries (referred to as Article 5 Parties) and developed countries (referred to as non-Article 5 Parties) for each group of substances. The timetable includes: CFCs by 1 January 1996 for non-Article 5 Parties and by 1 January 2010 for Article 5 Parties (with possible exemptions);Halons by 1 January 1994 for non-Article 5 Parties and by 1 January 2010 for Article 5 Parties (with possible exemptions);HCFCs by 1 January 2020 for non-Article 5 Parties and by 1 January 2030 for Article 5 Parties (with possible exemptions and a small percentage can be used for servicing existing refrigeration and air-conditioning equipment (i.e. an allowance of 0.5 % of base level consumption until January 1, 2030 for servicing of refrigeration and air-conditioning equipment existing on 1 January 2020 for non-Article 5 Parties, and an allowance of 2.5 % of base level consumption when averaged over 10 years 2030-2040 until January 1, 2040 for servicing of refrigeration and air conditioning equipment existing on 1 January 2030 for Article 5 Parties);For HFCs the first reduction step for non-Article 5 Parties is in 2019, while most Article 5 Parties will start their phase-down in 2024. Article 4 of the Montreal Protocol includes non-party trade rules: These prohibit or restrict countries which are party to the Protocol from trading in controlled substances with countries not party to the Protocol. By doing so, they aim at maximising participation in the Protocol. The provisions were applied originally to the initial groups of ODSs and have been extended over time to include the additional groups of substances included in the Protocol in successive amendments. Parties to the Montreal Protocol: adopt procedures for determining measures of non-compliance and for treating Parties found to be in non-compliance;assess every 4 years, since 1990, implementation of the control measures, including the possibility of adding or removing substances from the banned lists;have annual reporting obligations on each of the controlled substances. The data must be provided to the Protocol’s Secretariat;cooperate to promote relevant best technologies, control strategies and possible alternatives to the substances;promote technical assistance to help non-Party countries participate in and implement the protocol;hold regular meetings which are serviced by the secretariat;provide the funds for the operation of the Protocol, including for the functioning of the secretariat;may notify their intention to withdraw from the Protocol under the conditions specified in Article 19. FROM WHEN DO THE PROTOCOL, ITS AMENDMENTS AND THE RELATED DECISIONS APPLY? The original Montreal Protocol entered into force on 1 January 1989. Decision 88/540/EEC has applied since 25 October 1988. The first amendment to the Montreal Protocol, London, 1990 entered into force on 10 August 1992. Decision 91/690/EEC has applied since 23 December 1991. The second amendment to the Montreal Protocol, Copenhagen 1992 entered into force on 14 June 1994. Council Decision 94/68/EC has applied since 14 February 1994. The third amendment to the Montreal Protocol, Montreal, 1997 entered into force on 10 November 1999. Decision 2000/646/EC has applied since 17 October 2000. The fourth amendment to the Montreal Protocol, Beijing, 1999 entered into force on 25 February 2002. Decision 2002/215/EC has applied since 4 March 2002. The fifth amendment to the Montreal Protocol, Kigali, 2016 entered into force on 1 January 2019. Decision (EU) 2017/1541 has applied since 18 July 2017. BACKGROUND To date, the Montreal Protocol is the only UN treaty that has been ratified by all countries of the world — all 197 UN member-countries. It represents an important milestone in the UN’s history. It evolves over time in the light of scientific, technical and economic developments. It now covers nearly 100 man-made chemicals that damage the ozone layer’s ability to protect humans and other life from harmful ultraviolet radiation from the sun. The EU implements the protocol through its own legislation which contains stricter and more ambitious measures. While the protocol regulates the production of the substances and their bulk trade, Regulation (EC) No 1005/2009 on substances that deplete the ozone layer, for instance, prohibits their use in products and equipment and regulates and monitors substances that are not covered by the Protocol. In addition, Regulation (EU) No 517/2014 on reducing fluorinated greenhouse gases includes an ambitious phase-down of HFCs, which started already in 2015 and which also covers HFCs contained in certain products and equipment. Regulation (EU) No 517/2014 also includes prohibitions on placing on the market of certain new products and equipment containing fluorinated gases and includes several measures that prevent emissions. For more information, see: Protection of the ozone layer (European Commission)Fluorinated greenhouse gases (European Commission). MAIN DOCUMENTS Montreal Protocol on substances that deplete the ozone layer — Declaration by the European Economic Community (OJ L 297, 31.10.1988, pp. 21-28) Amendment to the Montreal Protocol on substances that deplete the ozone layer (OJ L 377, 31.12.1991, pp. 30-40) Amendment to the Montreal Protocol on substances that deplete the ozone layer (OJ L 33, 7.2.1994, pp. 3-10) Amendment to the Montreal Protocol adopted by the ninth meeting of the parties (OJ L 272, 25.10.2000, pp. 27-28) Amendment to the Montreal Protocol on substances that deplete the ozone layer (OJ L 72, 14.3.2002, pp. 20-22) Amendment to the Montreal Protocol on substances that deplete the ozone layer (OJ L 236, 14.9.2017, pp. 3-13) Council Decision 88/540/EEC of 14 October 1988 concerning the conclusion of the Vienna Convention for the protection of the ozone layer and the Montreal Protocol on substances that deplete the ozone layer (OJ L 297, 31.10.1988, pp. 8-9) Council Decision 91/690/EEC of 12 December 1991 concerning the conclusion of the amendment to the Montreal Protocol on substances that deplete the ozone layer as adopted in June 1990 in London by the Parties to the Protocol (OJ L 377, 31.12.1991, pp. 28-40) Council Decision 94/68/EC of 2 December 1993 concerning the conclusion of the amendment to the Montreal Protocol on substances that deplete the ozone layer (OJ L 33, 7.2.1994, pp. 1-2) Council Decision 2000/646/EC of 17 October 2000 concerning the conclusion of the amendment to the Montreal Protocol on substances that deplete the ozone layer (OJ L 272, 25.10.2000, p. 26) Council Decision 2002/215/EC of 4 March 2002 concerning the conclusion of the Fourth Amendment to the Montreal Protocol on substances that deplete the ozone layer (OJ L 72, 14.3.2002, pp. 18-19) Council Decision (EU) 2017/1541 of 17 July 2017 on the conclusion, on behalf of the European Union, of the Kigali Amendment to the Montreal Protocol on substances that deplete the ozone layer (OJ L 236, 14.9.2017, pp. 1-2) RELATED DOCUMENTS Paris Agreement (OJ L 282, 19.10.2016, pp. 4-18) Council Decision (EU) 2016/1841 of 5 October 2016 on the conclusion, on behalf of the European Union, of the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (OJ L 282, 19.10.2016, pp. 1-3) Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, pp. 1-30) Successive amendments to Regulation (EC) No 1005/2009 have been incorporated into the original text. This consolidated version is of documentary value only. Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorimated greenhouse gases and repealing Regulation (EC) No 842/2006 (OJ L 150, 20.5.2014, pp. 195-230) last update 12.12.2019


EUR-Lex - 31985Y0604(01) - EN Avis juridique important | 31985Y0604(01) Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards Official Journal C 136 , 04/06/1985 P. 0001 - 0009 Spanish special edition: Chapter 16 Volume 1 P. 0248 Portuguese special edition Chapter 16 Volume 1 P. 0248 COUNCIL RESOLUTION of 7 May 1985 on a new approach to technical harmonization and standards (85/C 136/01) THE COUNCIL, in extension of its conclusions on standardization, approved on 16 July 1984 (Annex I); emphasizes the urgent need to resolve the present situation as regards technical barriers to trade and dispel the consequent uncertainty for economic operators; emphasizes the importance and desirability of the new approach which provides for reference to standards - primarily European standards, but national ones if need be, as a transitional measure - for the purposes of defining the technical characteristics of products, an approach outlined by the Commission in its communication of 31 January 1985, which follows certain guidelines adopted by the European Parliament in its resolution of 16 October 1980 and forms part of the extension of the Council's conclusions of 16 July 1984; aware that the new approach will have to be accompanied by a policy on the assessment of conformity, calls on the Commission to give this matter priority and to expedite all its work in this area; approves the guidelines encapsulated in the list of principles and main elements to be embodied in the main part of the Directives (Annex II to this resolution); calls on the Commission to submit suitable proposals as soon as possible. ANNEX I CONCLUSIONS ON STANDARDIZATION Approved by the Council on 16 July 1984 The Council believes that standardization goes a long way towards ensuring that industrial products can be marketed freely and also towards creating a standard technical environment for undertakings in all countries, which improves competitiveness not only on the Community market but also on external markets, especially in new technology. It recognizes that the objectives being pursued by the Member States to protect the safety and health of their people as well as the consumer are equally valid in principle, even if different techniques are used to achieve them. Accordingly, the Council adopts the following principles for a European standardization policy: - agreement by the Member States to keep a constant check on the technical regulations which are applied - whether de jure or de facto - on their territory so as to withdraw those which are obsolete or unnecessary; - agreement by the Member States to ensure the mutual recognition of the results of tests and the establishment, where necessary, of harmonized rules as regards the operation of certification bodies; - agreement to early Community consultation at an appropriate level, in accordance with the objectives of Directive 189/83/EEC where major national regulatory initiatives or procedures might have adverse repercussions on the operation of the internal market; - extension of the Community practice in matters of technical harmonization of entrusting the task of defining the technical characteristics of products to standards, preferably European but if necessary national, where the conditions necessary for this purpose, particularly as regards health protection and safety, are fulfilled; - a very rapid strengthening of the capacity to standardize, preferably at European level, with a view to facilitating on the one hand harmonization of legislation by the Community and on the other industrial development, particularly in the field of new technologies, since this could in specific circumstances involve the Community in introducing new procedures to improve the drawing up of standards (e.g. standardization bureaus, ad hoc committees). The adoption of European standards would be submitted to the European standardization bodies for approval. In high technology sectors particularly, subjects should be identified where common specifications and standards will make for efficient exploitation of the Community dimension and the opening of public works and supply contracts so that the decisions required in this connection may be taken. ANNEX II GUIDELINES FOR A NEW APPROACH TO TECHNICAL HARMONIZATION AND STANDARDS The following are the four fundamental principies on which the new approach is based: - legislative harmonization is limited to the adoption, by means of Directives based on Article 100 of the EEC Treaty, of the essential safety requirements (or other requirements in the general interest) with which products put on the market must conform, and which should therefore enjoy free movement throughout the Community, - the task of drawing up the technical specifications needed for the production and placing on the market of products conforming to the essential requirements established by the Directives, while taking into account the current stage of technology, is entrusted to organizations competent in the standardization area, - these technical specifications are not mandatory and maintain their status of voluntary standards, - but at the same time national authorities are obliged to recognize that products manufactured in conformity with harmonized standards (or, provisionally, with national standards) are presumed to conform to the "essential requirements" established by the Directive. (This signifies that the producer has the choice of not manufacturing in conformity with the standards but that in this event he has an obligation to prove that his products conform to the essential requirements of the Directive. ) In order that this system may operate it is necessary: - on the one hand that the standards offer a guarantee of quality with regard to the "essential requirements" established by the Directives, - on the other hand that the public authorities keep intact their responsibility for the protection of safety (or other requirements envisaged) on their territory. The quality of harmonized standards must be ensured by standardization mandates, conferred by the Commission, the execution of which must conform to the general guidelines which have been the subject of agreement between the Commission and the European standardization organizations. In so far as national standards are concerned their quality must be verified by a procedure at Community level managed by the Commission, assisted by a standing committee composed of officials from national administrations. At the same time safeguard procedures must be provided for, under the management of the Commission assisted by the same committee, in order to allow the competent public authorities the possibility of contesting the conformity of a product, the validity of a certificate or the quality of a standard. In following this system of legislative harmonization in each area in which it is feasible, the Commission intends to be able to halt the proliferation of excessively technical separate Directives for each product. The scope of Directives according to the "general reference to standards" formula should encompass wide product categories and types of risk. The Community could on the one hand, therefore, complete the extremely complex undertaking of harmonizing technical legislation and on the other hand promote the development and application of European standards. These are essential conditions for the improvement of the competitiveness of its industry. OUTLINE OF THE PRINCIPLES AND MAIN ELEMENTS WHICH SHOULD MAKE UP THE BODY OF THE DIRECTIVES A. JUSTIFICATIONS Amongst the traditional principles justifying a Directive the following aspects should be emphasized: - Member States have the responsibility of ensuring safety on their territory (in the home, at the workplace, etc.) of persons, domestic animals and goods, or the respect of other essential protection requirements in the general interest such as health, consumer or environmental protection etc., with regard to the hazards covered by the Directive itself (1); - the national provisions ensuring such protection must be harmonized in order to ensure the free movement of goods, without lowering existing and justified levels of protection in the Member States; - CEN and CENELEC (one or the other, or both according to the products covered by the Directive) are the competent bodies to adopt European harmonized standards within the scope of the Directive, in accordance with the guidelines which the Commission, after consultation of the Member States, has signed with these bodies (2). (1) For reasons of convenience and ease of drafting the rest of this document refers only to safety. (2) For specific sectors of industrial activity other competent European bodies for the drawing up of technical specifications could be involved. 1. In this outline a general approach is developed which should be applied according to the needs for legislation by Directives based on Article 100 of the Treaty relating to sectors or families of products as well as types of hazard. 2. The object of the Directive will be specified in each sphere of application according to the types of hazard (safety, health, environmental, consumer protection, etc.) and should the need arise to the circumstances (in the home, at the place of work, under road traffic conditions, during leisure activities, etc.). 3. Where appropriate, it should be stated that the Member States may make provision, in accordance with Community law, for national regulations concerning the conditions for use of products covered by the scope of the Directive. 4. Concerning the objective mentioned in the second principle, it is obvious that it is carried into effect by the very adoption of the Directive under Article 100 of the Treaty, as the essential safety requirements contained in it are of such a nature as to ensure the pursuit of such an objective. B. MAIN ELEMENTS I. Scope Definition of the range of products covered, as well as the nature of the hazards it is intended to avert. The scope should be defined in such a way that a consistent approach to the action is ensured, and that the proliferation of Directives on specific products is avoided. Moreover, it should be noted that the enacting terms of such a Directive do not preclude the possibility of several Directives being adopted on one and the same product according to the various types of hazard associated with that product (for example, mechanical safety of a machine on the one hand and pollution by that machine on the other hand). II. General clause for placing on the market The products covered by the Directive may be placed on the market only if they do not endanger the safety of persons, domestic animals or goods when properly installed and maintained and used for the purposes for which they are intended. 1. The Directives would provide for total harmonization as a general rule. Consequently, any product placed on the market falling within the scope of the Directive must be in conformity with the requirements of the Directive. In certain specific conditions, optional harmonization for certain products may prove to be opportune. The outline Directive, however, is drawn up with a view to total harmonization. Appropriate solutions could be envisaged in order to take account of the need to support, in some Member States, a harmonious move towards the introduction of a system of binding regulations, in order in particular to ensure the establishment of appropriate certification infrastructures. Point II therefore represents a general clause setting out the responsibilities of the Member States in relation to the placing of goods on the market. 2. In order to respect the general principle on which the outline Directive is based, which is to leave to the trade the choice of the means of attestation of conformity and thus to prohibit Member States from setting up any system of control prior to placing on the market (except, of course, in cases where prior control is required by specific Directives for special sectors, as is moreover clearly provided for in point VIII), it is obvious that the national authorities in order to acquit themselves of their responsibilities set out in this clause must be allowed to exercise control on the market by way of spot checks. 3. In certain cases, in particular with regard to the protection of workers and consumers, the conditions set out in this clause may be strengthened (foreseeable use). III. Essential safety requirements Description of the safety requirements which are essential for the application of the general clause in point II with which all products covered by the Directive must conform. 1. The essential safety requirements which must be met in the case of products which can be put on the market shall be worded precisely enough in order to create, on transposition into national law, legally binding obligations which can be enforced. They should be so formulated as to enable the certification bodies straight away to certify products as being in conformity, having regard to those requirements in the absence of standards. The degree of detail of the wording will depend on the subject matter. If the basic requirements for safety are observed, the general clause in point II can be applied. 2. Amendments to these requirements can be made only by means of a new Council Directive under Article 100 of the Treaty. IV. Free movement clause Obligation on the Member States to accept, under the conditions referred to in point V, the free movement of products which conform to points II and III. 1. Free movement will be ensured in the case of products declared to conform to the protection requirements laid down in the Directive, without recourse as a general rule to prior verification of compliance with the requirements set out in point III, it being understood that note 2 of point II also applies in this case. The interpretation to be given to this provision should not have the consequence that third party certification is to be systematically required by the sectoral Directives. 2. The actual aim of the Directives in question is to cover all essential requirements, but in the exceptional case of cover proving incomplete, it would always be possible for a Member State to act under Article 36 of the Treaty. V. Means of proof of conformity and effects 1. Member States shall presume to be in conformity with points II and III products which are accompanied by one of the means of attestation described in point VIII declaring that they are in conformity with: (a) the harmonized standards adopted by the European standardization body which is particularly competent within the scope of this Directive, when these standards are adopted in accordance with the general guidelines agreed between that body and the Commission and the references of which are published in the Official Journal of the European Communities ; such publication should, moreover, also be carried out by the Member States; (b) or as a transitional measure, and in so far as harmonized standards do not exist in the field covered by such standards, national standards referred to in paragraph 2. 2. Member States shall communicate to the Commission the text of those national standards which they consider to meet points II and III. The Commission shall forthwith forward this text to the other Member States. In accordance with the procedure laid down in paragraph 2 of Point VI, the Commission shall notify the Member States of the national standards which enjoy the presumption of conformity with points II and III. Member States are required to publish the references of these standards. The Commission shall also ensure that they are published in the Official Journal of the European Communities. 3. Member States shall accept that the products for which the manufacturer has not applied any standard (because of absence of a standard as laid down in paragraphs 1 (a) and (b) above or for other exceptional reasons, are considered to be in conformity with points II and III, when their conformity is demonstrated by one of the means of attestation set out in point VIII, paragraph 1 (a) and (b). 1. Only those means of attestation provided for in point VIII necessarily carry presumption of conformity. 2. The presumption of conformity is constituted by the fact that the conformity of a product to harmonized or national standards is declared by one of the means of attestation set out in point VIII. When the product is not in conformity with a standard, because the standards do not exist or because the manufacturer, for example in cases of innovation, prefers to apply other manufacturing criteria of his choice, conformity to points II and III is declared by the means of an attestation delivered by an independent body. 3. In cases under point V, paragraphs 1 and 3, Member States will therefore have the right, for the presumption to operate, to request at any time one of the means of attestation set out in point VIII. 4. The drafting and adoption of the harmonized standards mentioned in paragraph 1 (a) by the CEN and CENELEC, these bodies being generally considered to be the "European standards bodies which are particularly competent", and the obligation relating to transposition into national standards are governed by these two bodies" internal rules and their regulations relating to standards work. The internal rules of CEN and CENELEC are in the process of being harmonized. However, it is not ruled out that the harmonized standards referred to in paragraph 1 (a) will be prepared outside CEN and CENELEC by other bodies which may assume these functions in particular areas ; in such cases adoption of the harmonized standards shall be submitted for approval by CEN/CENELEC. In any case, the drafting and introduction of the harmonized standards referred to in point V must be subject to the guidelines agreed between the Commission and these organizations. The guidelines deal in particular with the following principles and conditions: - the availability of suitable staff and technical infrastructure at the standards body which the Commission mandates to proceed with standardization; - the association of public authorities and interested circles (in particular manufacturers, users, consumers, unions); - the adoption of harmonized standards and their transposition into national standards or, at least, the annulment of diverging national standards under conditions approved by the Commission when drawing up a frame of reference for standardization after consultation with the Member States. 5. In the selection of national standards, due consideration will be given to any practical difficulties arising from that selection. National standards are selected only on a transitional basis. Accordingly, when a selection decision is made, the relevant European bodies will in principle be sent instructions to draft and adopt the corresponding European standards within a given period of time and under the conditions stated above. VI. Management of the list of standards 1. Where a Member State or the Commission considers that harmonized standards or drafts thereof do not fully satisfy points II and III, the Commission or the Member State shall bring this to the attention of the committee (point X) setting out the reasons. The committee shall give an opinion as a matter of urgency. The Commission shall, in the light of the committee's opinion, notify the Member States of the necessity of withdrawing or not withdrawing the standard from the publication referred to in point V, paragraph 1 (a). It shall inform the European standards body concerned and, if necessary, give it a new or revised mandate. 2. On receipt of the communication referred to in point V, paragraph 2, the Commission shall consult the committee. After the committee has given its opinion, the Commission shall, within a given period, notify the Member States whether the national standard in question should or should not enjoy presumption of conformity and, if so, be subject to national publication of its references. If the Commission or a Member State considers that a national standard no longer fulfils the conditions for presumption of conformity to the safety requirements, the Commission shall consult the committee. In the light of the opinion of the committee, it shall notify the Member States whether or not the standard in question should continue to enjoy presumption of conformity and in the latter case be withdrawn from the publications referred to in point V, paragraph 2. As indicated above (see notes to point V, paragraph 2) the Member States have the power to decide which of their national standards may be considered to be in conformity with points II and III and thus be subject to the Commission confirmation procedure. VII. Safeguard clause 1. Where a Member State finds that a product might compromise the safety of individuals, domestic animals or property, it shall take all appropriate measures to withdraw or prohibit the placing on the market of the product in question or to restrict its free movement even if it is accompanied by one of the means of attestation referred to in point VIII. Within a given period of time, and only when the product in question is accompanied by one of the means of attestation provided for in point VIII, the Member State shall inform the Commission of such a measure. It will indicate the reasons for its decision and in particular whether the non-conformity results from: (a) non-compliance with points II and III (when the product does not conform to any standard); (b) incorrect application of the standards referred to in point V; (c) a shortcoming in the standards themselves. 2. The Commission shall consult the Member States concerned as soon as possible. If the Member State which has taken measures intends to maintain them, the Commission shall refer the matter to the committee within a specified period. Where the Commission, after consultation of the committee, finds that the action is justified it shall, also within a given period of time, inform the Member State in question and point out to the other Member States that (all else being equal) they are also obliged to prevent the product in question from being placed on the market. 3. Where failure of the product to comply with points II and III results from a shortcoming in the harmonized standards or in the national standards, the consequences shall be those set out in point VI. 4. Where the non-conforming product is accompanied by a means of attestation issued by an independent body or by the manufacturer, the competent Member State shall take the appropriate measures against the author of the attestation and inform the Commission and the other Member States. 5. The Commission shall ensure that all Member States are kept informed of the progress and of the outcome of this procedure. This point describes the consequences when recourse by a Member State to the safeguard clause appears to be justified. It does not give any indication on the consequences when recourse does not appear to be justified after expiry of the Community examination procedure, because in such cases the general rules of the Treaty apply. VIII. Means of attestation of conformity 1. The means of attestation referred to in point V which the trade may use are: (a) certificates and marks of conformity issued by a third party; (b) results of tests carried out by a third party; (c) declaration of conformity issued by the manufacturer or his agent based in the Community. This may be coupled with the requirement for a surveillance system; (d) other means of attestation which could possibly be determined in the Directive. 2. The choice by trade and industry between these different means may be limited, or even removed, according to the nature of the products and hazards covered by the Directive. 3. National bodies authorized to issue marks or certificates of conformity shall be notified by each Member State to the Commission and to the other Member States. 1. The appropriate means of attestation will be established and expanded in the specific Directives taking into account the special requirements of their scope. It must be borne in mind that the certification bodies designated by the Member States for cases (a) and (b) will have to intervene in particular in the absence of standards and where the manufacturer does not observe standards (see point V, paragraph 3). 2. The bodies referred to in paragraph 3 must carry out their duties according to recognized international practices and principles and especially in accordance with ISO Guides. The responsibility for the control of the operation of these bodies lies with the Member States. Questions concerning the carrying out of tests and certification may be put before the committee set up under point IX. 3. With regard to the manufacturer's declaration of conformity, the national authorities have the right to ask the manufacturer or the importer to communicate the data relating to the tests carried out concerning safety etc., when they have good grounds for believing that a product does not offer the degree of safety required in all respects. Refusal on the part of the manufacturer or the importer to communicate these data constitutes sufficient reason to doubt the presumption of conformity. 4. The determination of a limitative list of means of attestation only concerns the system of presumption of conformity but cannot have the effect of restricting the possibility for a member of the trade to prove, by any means he sees fit within the framework of a dispute or court proceedings, the conformity of the product with points II and III. IX. Standing committee A standing committee shall be set up chaired by a representative of the Commission and consisting of representatives appointed by the Member States who may avail themselves of the help of experts or advisers. The committee shall be convened by its chairman either on his own initiative or at the request of a Member State. The committee shall draw up its own rules of procedure. X. Tasks and operation of the committee 1. The committee shall carry out the tasks entrusted to it by virtue of the foregoing points. 2. Furthermore, any question regarding the implementation of a Directive may be submitted to the committee. The tasks of the committee shall be concerned with the implementation of the Directive. The object of the consultation of the Committee prior to the publication of the references of the national standards is more to provide for a forum for the discussion of the objections which the Commission or a Member State may formulate, than to carry out a systematic examination of the entire contents of the standards. Criteria for choosing the priority areas in which this approach could initially be applied 1. The need to find a new approach to the harmonization of technical regulations, based on "general reference to standards" and following the lines described earlier, is the outcome of a number of conditions (outlined in the first part of this communication) backed up by the experience already acquired by the Community. Consequently it is a general principle, the validity of which will have to be assessed in practical terms in the various areas in which it will be applied. The Council took a similar view in its "Conclusions" of 16 July 1984 when it confirmed the general need for an extension of the "general reference to standards" practice, but only provided the necessary conditions were fulfilled, i.e. as regards the obligation on public authorities to protect the health and safety of their citizens. 2. Before the priority areas in which this approach should initially be applied can be chosen, it is therefore necessary to establish a number of selection criteria to be taken into consideration, criteria which cannot be taken separately. (a) Since the approach calls for the "essential requirements" to be harmonized and made mandatory by Directives based on Article 100 of the Treaty, the "general reference to standards" approach will be appropriate only where it is genuinely possible to distinguish between "essential requirements" and "manufacturing specifications". In other words, in all areas in which the essential requirements in the public interest are such that a large number of manufacturing specifications have to be included if the public authorities are to keep intact their responsibility for protection of their citizens, the conditions for the "general reference to standards" approach are not fulfilled as this approach would have little sense. In the light of this statement areas involving safety protection certainly appear to have priority over those involving health protection (which applies to the scope of Directive 83/189). (b) If "general reference to standards" is to be possible, the area concerned must be covered by, or be capable of being covered by, standardization. Areas which are inherently ill suited to standardization work are certainly the areas referred to in (a) above where the need for regulations is felt unanimously throughout the Community. In other areas there is a standardization capacity or potential and in the latter case the Community should encourage it in close cooperation with both the industry concerned and the European standards bodies, whilst ensuring that the interests of consumers are taken into account. (c) The progress of technical harmonization work in the Community under the general programme established by the Council resolutions of 1969 and 1973 varies greatly from one industrial sector to another. In manufacturing industry (which appears at first sight better to fulfil the abovementioned criteria) most of the Directives adopted concern three areas : motor vehicles, metrology and electrical equipment. The new approach will therefore have to take this state of affairs into account and concentrate mainly on other areas in which there is a lack of Community activities (e.g. many engineering products and building materials) without calling into question regulations that are already well advanced (for example those referring to motor vehicles). The case of electrical equipment is different : this is the only area to have been tackled by a Directive of the "general reference to standards" type and should certainly be included in the priority areas for all such products not yet covered, in view of the extremely important part played in this area by international and European standardization. (d) One of the main purposes of the new approach is to make it possible to settle at a stroke, with the adoption of a single Directive, all the problems concerning regulations for a very large number of products, without the need for frequent amendments or adaptations to that Directive. Consequently in the selected areas there should be a wide range of products sufficiently homogeneous to allow common "essential requirements" to be defined. This general criterion is, however, based mainly on practical and labour-saving considerations. There is nothing to prevent a single type of product, in certain cases, from being covered by the "general reference to standards" formula if all the abovementioned criteria are met. (e) Finally, mention should be made of one criterion that the Commission, in agreement with industry, has always regarded as essential. There must be grounds for considering that the existence of different regulations does in practice genuinely impede the free movement of goods. In some cases, however, even if these grounds are not obvious, a Directive may appear necessary to protect an essential public interest uniformly throughout the Community.

Summary: A new approach to technical harmonisation A new approach to technical harmonisation This Resolution aims to recast technical harmonisation within the European Union (EU) on a new basis by only harmonising the essential requirements of products and by applying the "general reference to standards" formula and the principle of mutual recognition in order to eliminate technical obstacles to the free movement of goods. ACT Council Resolution 85/C 136/01 of 7 May 1985 on a new approach to technical harmonization and standards. SUMMARY The main aim of this Resolution is to develop an approach establishing general rules which are applicable to sectors or families of products as well as types of hazard. This Resolution establishes a number of fundamental principles for a European standardisation policy: the Member States undertake to keep a constant check on the technical regulations which are applied so as to withdraw those which are deemed obsolete or superfluous; the Member States ensure the mutual recognition of the results of tests and establish harmonised rules on the operation of certification bodies (the mutual recognition principle); the Member States agree to early Community consultation where national regulatory proposals or procedures might pose a threat to the smooth operation of the internal market; there is a need to extend the "general reference to standards", preferably to European but if necessary national standards, and to define the task of standardisation as the formulation of technical characteristics of products (particularly as regards health protection and safety); there is a need to rapidly strengthen the capacity to standardise, preferably at European level; the adoption of European standards should be submitted to the European standardisation bodies for approval. General guidelines for the new approach The Council establishes four fundamental principles: legislative harmonisation is limited to essential safety requirements (or other requirements in the general interest) with which products put on the market must conform and can therefore enjoy free movement throughout the European Union; the task of drawing up technical production specifications is entrusted to organisations competent in industrial standardisation, which take the current stage of technology into account when doing so; these technical specifications are not mandatory and maintain their status of voluntary standards; the authorities are obliged to recognise that products manufactured in conformity with harmonised standards are presumed to conform to the essential requirements established by the Directive. If the producer does not manufacture in conformity with these standards, he has an obligation to prove that his products conform to the essential requirements. Two conditions have to be met in order that this system may operate: the standards must guarantee the quality of the product; the public authorities must ensure the protection of safety (or other requirements envisaged) on their territory. This is a necessary condition to establish mutual trust between Member States. The Commission issues standardisation mandates to the European standardisation organisations. Agreements between the Commission and these organisations ensure that they are carried out in accordance with the general guidelines. In the absence of European standards, national standards are verified by a procedure at European level managed by the Commission, which is assisted by a standing committee composed of officials from national administrations. Safeguard procedures are provided for in order to allow the national authorities the possibility of contesting the conformity of a product or the quality of a standard. The scope of a directive is defined by the wide product categories and/or types of risk it encompasses. Outline of a "new approach" directive Member States have the responsibility of ensuring the safety on their territory of persons, domestic animals and goods. The provisions ensuring such protection must be harmonised in order to ensure the free movement of goods, without lowering existing levels of protection in the Member States. The European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (CENELEC) are the competent bodies to adopt European harmonised standards within the scope of the Directive. For specific sectors of industrial activity, other competent European bodies for the drawing up of technical specifications could be involved. The definition of the range of products covered, as well as the nature of the hazards it is intended to avert, should ensure a consistent approach. This does not preclude the possibility of several Directives being adopted for the various types of hazard associated with the same category of product. The products covered by a Directive may be placed on the market only if they do not endanger the safety of persons, domestic animals or goods. The Directives provide for total harmonisation as a general rule - i.e. that only products which conform can be placed on the market. The directive should contain a description of the safety requirements with which all products covered by the Directive must conform. It should be worded precisely enough in order to create, on transposition into national law, legally binding obligations which can be enforced. Free movement of the product in question is ensured, without recourse to prior verification of compliance with the essential requirements. The Member States presume conformity for products which are accompanied by one of the means of attestation described in the directive declaring that they are in conformity either with the harmonised standards or, in the absence of harmonised standards, with national standards. Where a Member State considers that a harmonised standard does not satisfy the essential requirements, the Commission shall bring this to the attention of the Committee on Standards and Technical Regulations which gives an opinion as a matter of urgency. In the light of this opinion, the standard can be maintained, withdrawn or revised. Should a Member State find that a product might compromise the safety of individuals, domestic animals or property, it takes all appropriate measures to withdraw or prohibit the placing on the market of the product in question. The free movement of the product can be restricted, even if it is accompanied by an attestation of conformity. If this is the case, the Member State informs the Commission of such a measure, indicating the reasons for its decision. The Commission enters into consultation with the Member States and the standing committee. If the action is felt to have been justified, the Commission informs the Member States who are obliged to prevent the product in question from being placed on the market. The means of attestation which the trade may use are: certificates and marks of conformity issued by a third party; the results of tests carried out by a third party; the declaration of conformity issued by the manufacturer, which may be coupled with a surveillance system; other means of attestation which could possibly be determined in the Directive. The national bodies authorised to issue marks or certificates of conformity are notified by the Member State to the Commission and to the other Member States. They must carry out their duties in accordance with International Standardisation Organisation (ISO) principles and practices. The Member States are responsible for controlling the operation of these bodies. The national authorities have the right to ask the manufacturer to provide them with the data relating to the safety tests carried out when they have doubts about its conformity with safety requirements. Any manufacturer may prove, by any means he sees fit within the framework of a dispute or court proceedings, the conformity of the product. The sectoral directives standing committee is made up of representatives appointed by the Member States who may avail themselves of the help of experts or advisers. The tasks of the committee are concerned with the implementation of the Directive. The Committee constitutes a forum for discussing any possible objections, but is not intended to carry out a systematic examination of the entire contents of the standards. Criteria for selecting the areas in which the "general reference to standards" could be applied: since it is only the essential requirements which are to be harmonised, it should be possible to distinguish between essential requirements and manufacturing specifications; the area concerned must be covered by standardisation (or the need for regulations is felt unanimously throughout the Community); most of the Directives adopted concern the three areas of motor vehicles, metrology and electrical equipment. The new approach should thus initially concentrate on other areas; the possibility of settling, with the adoption of a single Directive, all the problems concerning regulations for a large number of products, without the need for frequent amendments or adaptations to that Directive (based mainly on practical and labour-saving considerations). Consequently, the selected areas should be characterised by a wide range of products which are sufficiently homogeneous to allow common "essential requirements" to be defined. RELATED ACTS Directive 98/34/EC of the Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations [Official Journal L 204 of 21.7.1998]. See also The Directorate-General for Enterprise website concerning the New Approach European Committee for Standardisation (CEN) European Committee for Electrotechnical Standardisation (CENELEC) Last updated: 13.07.2011