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31992L0042

Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels

Official Journal L 167 , 22/06/1992 P. 0017 - 0028 Finnish special edition: Chapter 13 Volume 23 P. 0055  Swedish special edition: Chapter 13 Volume 23 P. 0055

COUNCIL DIRECTIVE 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuelsTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Decision 91/565/EEC (4) provides for the promotion of energy efficiency in the Community under the SAVE programme;  Whereas it is important to promote measures aimed at the progressive establishement of the internal market in the period up to 31 December 1992; whereas the internal market encompasses an area without internal frontiers, in which the free circulation of  goods, persons, services and capital is assured;  Whereas the Council resolution of 15 January 1985 on the improvement of energy-saving programmes in the Member States (5) invites Member States to pursue and where necessary increase their efforts to promote the more rational use of energy by the  further development of integrated energy-saving policies;  Whereas the Council resolution of 16 September 1986 concerns new Community energy-policy objectives for 1995 and convergence of the policies of the Member States (6), and in particular the objective of improving the efficiency of final energy demand by  at least 20 %;  Whereas Article 130r of the Treaty provides that action by the Community relating to the environment shall have the objective of ensuring a prudent and rational utilization of natural resources;  Whereas it is appropriate to take as a base a high level of protection in proposals for the approximation of the provisions laid down by law, regulation or administrative action in Member States and concerning health, safety, environmental protection  and consumer protection;  Whereas the Council resolution of 21 June 1989 declares 'that the Community should take proper account of potential climatic change linked to the greenhouse effect' (7) and the Council's conclusions of 29 October 1990 state that CO2 emissions in the  year 2000 should be stabilized throughout the Community at their 1990 level;  Whereas the importance of the domestic and tertiary sector, which absorbs a major proportion of the final consumption of energy in the Community, is considerable;  Whereas this sector will become even more important through trends towards more central heating and a general increase in thermal comfort;  Whereas better boiler efficiency is in the consumer's interest; whereas energy saving will be reflected in fewer imports of hydrocarbons; whereas reduction in the Community's energy dependence will have a positive impact on its trade balance;  Whereas Council Directive 78/170/EEC of 13 February 1978 on the performance of heat generators for space heating and the production of hot water in new or existing non-industrial buildings and on the insulation of heat and domestic hot-water  distribution in new non-industrial builings (8), has given rise to the establishment of substantially different efficiency levels between one Member State and another;  Whereas the requirement of high efficiency for hot-water boilers will reduce the range of technical properties of equipment placed on the market, thus facilitating series production and making for economies of scale; whereas the absence of a measure  laying down energy requirements at a sufficiently high level may result, with the completion of the internal market, in a significant drop in the efficiency levels of heating installations through the spread on the market of low-efficiency boilers;  Whereas local climatic conditions and the energy and occupancy characteristics of buildings differ greatly within the Community; whereas Member States must take this diversity into account when determining the conditions for putting boilers into service  in implementation of this Direcitve; whereas these circumstances justify the fact that Member States where back-boilers and boilers designed to be installed in the living space are widely installed at the date of the adoption of this Directive should  continue to authorize, within specific limits, the placing on their markets and the putting into service of such boilers; whereas these arrangements should be subject to particular surveillance by the Commission;  Whereas this Directive, which is aimed at eliminating technical barriers with regard to boiler efficiency, must follow the new approach established by the Council resolution of 7 May 1985 (9) which specifically lays down that legislative harmonization  is limited to the adoption, by means of directives based on Article 100 of the EEC Treaty, of the essential requirements with which products put on the market must conform and that 'these essential requirements shall be worded precisely enough in order  to create legally binding obligations which can be enforced and to enable the certification bodies to certify products as being in conformity, having regard to those requirements in the absence of standards';  Having regard to Directive 83/189/EEC (10) laying down a procedure for the provision of information in the field of technical standards and regulations;  Having regard to Decision 90/683/EEC (11) concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives;  Whereas boilers complying with the efficiency requirements should bear the CE mark and, where appropriate, signs in order to enable them to move freely and to be put into service in accordance with their intended purpose within the Community;  Having regard to Directive 89/106/EEC (12) on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products;  Whereas efficiency requirements to encourage the rational use of energy as laid down in Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels (13) should be  established for the gas boilers referred to in this Directive,  HAS ADOPTED THIS DIRECTIVE:  Article 1  This Directive, which comes under the SAVE programme concerning the promotion of energy efficiency in the Community, determines the efficiency requirements applicable to new hot-water boilers fired by liquid or gaseous fuels with a rated output of no  less than 4 kW and no more than 400 kW, hereinafter called 'boilers'.  Article 2  For the purposes of this Directive:  - boiler: the combined boiler body-burner unit, designed to transmit to water the heat released from burning,  - appliance:  - the boiler body designed to have a burner fitted,  - the burner designed to be fitted to a boiler body,  - effective rated output (expressed in kW): the maximum calorific output laid down and guaranteed by the manufacturer as being deliverable during continuous operation while complying with the useful efficiency indicated by the manufacturer,  - useful efficiency (expressed in %): the ratio between the heat output transmitted to the boiler water and the product of the net calorific value at constant fuel pressure and the consumption expressed as a quantity of fuel per unit time,  - part load (expressed in %): the ratio between the effective output of a boiler operating intermittently or at an output lower than the effective rated output and the same effective rated output;  - average temperature of the boiler water: the average of the water temperatures at the entry and exit of the boiler,  - standard boiler: a boiler for which the average water temperature can be restricted by design,  - back-boiler: a boiler designed to supply a central-heating system and to be installed in a fireplace recess as part of a back boiler/gas fire combination,  - low-temperature boiler: a boiler which can work continuously with a water supply temperature of 35 to 40o C, possibly producing condensation in certain circumstances, including condensing boilers using liquid fuel,  - gas condensing boiler: a boiler designed to condense permanently a large part of the water vapour contained in the combustion gases,  - boiler to be installed in the living space: a boiler with an effective rated output of less than 37 kW, designed to provide heat to the part of the living space in which it is installed by means of the emission of heat from the casing having an open  expansion chamber, supplying hot water using gravity circulation; such boilers shall bear on their casings the explicit indication that they must be installed in living space.  Article 3  1. The following shall be excluded from this Directive:  - hot-water boilers capable of being fired by different fuels including solid fuels,  - equipment for the instantaneous preparation of hot water,  - boilers designed to be fired by fuels the properties of which differ appreciably from the properties of the liquid and gaseous fuels commonly marketed (industrial waste gas, biogas, etc),  - cookers and appliances designed mainly to heat the premises in which they are installed and, as a subsidiary function, to supply hot water for central heating and sanitary hot water,  - appliances with rated outputs of less than 6 kW using gravity circulation and designed solely for the production of stored sanitary hot water,  - boilers manufactured on a one-off basis.  2. In the case of boilers with a dual function, that of heating premises and also providing sanitary hot water, the efficiency requirements referred to in Article 5 (1) concern the heating function only.  Article 4  1. Member States may not prohibit, restrict or impede the placing on the market or entry into service within their territories of appliances and boilers which satisfy the requirements of this Directive, save as otherwise laid down in the Treaty or other  Directives or Community provisions.  2. Member States shall take all necessary measures to ensure that boilers cannot be put into service unless they satisfy the efficiency requirements set out in Article 5 (1) and the conditions for entry into service which the Member States lay down on  the basis of local climatic conditions and the energy and occupancy characteristics of the buildings.  3. However, Member States where back-boilers and/or boilers that are to be installed in the living space, are widely installed at the date of the adoption of the present Directive, shall continue to authorize their entry into service, provided that  their efficiency both at rated output and at 30 % part load is not more than 4 % below the requirements laid down in Article 5 (1) for standard boilers.  4. The effects of the provisions in paragraphs 2 and 3 shall be constantly monitored by the Commission and analysed in the report to be submitted under Article 10. To this end the Member States shall forward to the Commission any information it requires  to submit to the Council the proposed amendments, provided for in that Article, designed to ensure at all events the energy efficiency and free movement of boilers in the Community.  Article 5  1. Boilers must comply with the following useful efficiency requirements:  - at rated output, i.e. operating at rated output Pn expressed in kW, at an average boiler-water temperature of 70 oC,  and - a part load, i.e. operating at 30 % part load, at an average boiler-water temperature which varies according to the type of the boiler.  The useful efficiency requirements to be complied with are set out in the following table:    Type of boiler Range of power output Efficiency at rated output Efficiency at partload kW Average boiler-water temperature (in oC) Efficiency requirement expressed (in %) Average boiler-water temperature (in oC) Efficiency requirement expressed (in %) Standard boilers 4 to 400 70 & {Ì8}; 84 + 2 logPn & {Ì8}; 50 & {Ì8}; 80 + 3 logPn Lowtemperature boilers (*) 4 to 400 70 & {Ì8}; 87,5 + 1,5 logPn  40 & {Ì8}; 87,5 + 1,5 logPn Gas condensing boilers 4 to 400 70 & {Ì8}; 91 + 1 logPn  30 (**) & {Ì8}; 97 + 1 logPn (*) Including condensing boilers using liquid fuels.  (**) Temperature of boiler water-supply.  2. The harmonized standards relating to the requirements of this Directive drawn up under mandate from the Commission in accordance with Directive 83/189/EEC and 88/182/EEC (14) shall determine, inter alia, the verification methods valid for  production and measurements. Appropriate tolerances must be incorporated in the efficiency levels.  Article 6  1. Under the procedures laid down in Article 7, Member States may decide to apply a specific system of labels enabling the energy performance of boilers to be clearly ascertained. This system shall apply to boilers the efficiency of which is superior to  the requirements for standard boilers set out in Article 5 (1).  If its efficiency at rated output and its efficiency at part load are equal to or greater than the relevant values for standard boilers, a boiler shall be awarded an '& {ÌK};' as set out in Annex I, section 2.  If its efficiency at rated output and its efficiency at part load are three or more points higher than the relevant values for standard boilers a boiler shall be awarded '& {ÌK};& {ÌK};'.  Every extra step of efficiency of three points at rated output and at part load will allow the attribution of an extra '& {ÌK};' as set out in Annex II.  2. Member States may not authorize any other label likely to be confused with those referred to in paragraph 1.  Article 7  1. Member States shall deem that boilers which comply with the harmonized standards, the reference numbers of which have been published in the Official Journal of the European Communities and for which the Member States have published the reference  numbers of the national standards transposing those harmonized standards, to be in conformity with the essential efficiency requirements stipulated in Article 5 (1). Such boilers must bear the CE mark referred to in Annex 1, section 1, and be  accompanied by the EC declaration of conformity.  2. The conformity of series-produced boilers shall be certified by:  - examination of the efficiency of a boiler type in accordance with module B as described in Annex III,  - a declaration of conformity to the approved type in accordance with module C, D or E as described in Annex IV.  For boilers burning gaseous fuels, the procedures for assessing the conformity of their efficiency shall be those used to assess conformity to the safety requirements laid down in Directive 90/396/EEC on the approximation of the laws of the Member  States relating to appliances burning gaseous fuels.  3. When appliances marketed separately are placed on the market, they must bear the CE mark and be accompanied by the EC declaration of conformity, which defines the parameters enabling them after assembly to achieve the useful efficiency levels laid  down in Article 5 (1).  4. The CE mark of conformity to the requirements of this Directive and to the other provisions concerning the granting of the CE mark, and also the inscriptions specified in Annex I, shall be affixed on boilers in a visible, easily legible and indelible  manner. The affixing on such products of any other mark, sign or indication liable to create confusion with the CE mark both as regards its significance or in its appearance shall be prohibited.  Article 8  1. Each Member State shall notify the Commission and the other Member States of the bodies it has appointed to carry out the tasks relating to the procedures referred to in Article 7, hereinafter called 'notified bodies'.  The Commission shall allocate identification numbers to those bodies and shall inform the Member States thereof.  Lists of the notified bodies shall be published by the Council in the Official Journal of the European Communities and shall be continually updated.  2. Member States shall implement the minimum criteria laid down in Annex V for the appointment of such bodies. Bodies which satisfy the criteria laid down in the corresponding harmonized standards shall be deemed to comply with the criteria laid down in  that Annex.  3. A Member State which has notified a particular body must withdraw that notification if it finds that the body concerned no longer satisfies the criteria referred to in paragraph 2. It shall immediately inform the other Member States and the  Commission accordingly and shall withdraw the notification.  Article 9  1. By 1 January 1993, Member States shall adopt and publish the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.  They shall apply those provisions form 1 January 1994.  When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the  Member States.  2. Until 31 December 1997, Member States shall permit the placing on the market and putting into service of appliances complying with the national rules and schemes in force within their territories on the date of the adoption of this Directive.  Article 10  Three years after the implementation of this Directive the Commission shall submit a report to the European Parliament and to the Council on the results achieved. That report shall be accompanied by proposals for any changes to be made to this Directive  in the light of those results and of advances in technology.  Article 11  This Directive is addressed to the Member States.  Done at Brussels, 21 May 1992.  For the Council The President Luis MIRA AMARAL (1) OJ No C 292, 22. 11. 1990, p. 8.(2) OJ No C 129, 20. 5. 1991, p. 97 and OJ No C 94, 13. 4. 1992.(3) OJ No C 102, 18. 4. 1991, p. 46.(4) OJ No L 307, 8. 11. 1991, p. 34.(5) OJ No C 20, 22. 1. 1985, p. 1.(6) OJ No C 241, 25. 9. 1986, p.  1.(7) OJ No C 183, 20. 7. 1989, p. 4.(8) OJ No L 52, 23. 2. 1978, p. 32. Directive amended by Directive 82/885/EEC (OJ No L 378, 31. 12. 1982, p. 19).(9) OJ No C 136, 4. 6. 1985, p. 1.(10) OJ No L 109, 26. 4. 1983, p. 8; Directive last amended by  Decision 90/230/EEC (OJ No L 128, 18. 5. 1990, p. 15).(11) OJ No L 380, 31. 12. 1990, p. 13.(12) OJ No L 40, 11. 2. 1989, p. 12.(13) OJ No L 196, 26. 7. 1990, p. 15.(14) OJ No L 81, 26. 3. 1988, p. 75.   ANNEX I  CONFORMITY MARKS AND ADDITIONAL SPECIFIC MARKINGS  1. Conformity mark The conformity mark consists of the letters CE as shown below and the last two figures of the year in which the mark was affixed.  2. Additional specific markings The energy performance label awarded under Article 6 of this Directive consists of the following symbol:  & {ÌK};   ANNEX II  AWARD OF ENERGY-PERFORMANCE LABELS  Efficiency requirements to be met both at nominal output and at part-load of 0,3 Pn  Label Efficiency requirement at nominal output Pn and at an average boiler-water temperature of 70 oC % Efficiency requirement at part-load of 0,3 Pn and at an average boiler-water temperature of & {Ì8}; 50 oC % & {ÌK};  & {Ì8}; 84 + 2 log Pn & {Ì8}; 80 + 3 log Pn & {ÌK};& {ÌK};  & {Ì8}; 87 + 2 log Pn & {Ì8}; 83 + 3 log Pn & {ÌK};& {ÌK};& {ÌK};  & {Ì8}; 90 + 2 log Pn & {Ì8}; 86 + 3 log Pn & {ÌK};& {ÌK};& {ÌK};& {ÌK};  & {Ì8}; 93 + 2 log Pn & {Ì8}; 89 + 3 log Pn   ANNEX III Module B: EC type-examination 1. This module describes that part of the procedure by which a notified body ascertains and attests that an example, representative of the production envisaged, meets the relevant provisions of the Directive.  2. The application for EC type-examination is lodged by the manufacturer or his authorized representative established within the Community with a notified body of his choice.  The application must include:  - the name and address of the manufacturer and, if the application is lodged by the authorized representative, the name and address in addition,  - a written declaration that the same application has not been lodged with any other notified body,  - the technical documents, as described in section 3.  The applicant must place at the disposal of the notified body an example representative of the production envisaged, hereinafter called 'type'. The notified body may request further examples if needed for carrying out the test programme.  3. The technical documents must enable the conformity of the appliance with the requirements of the Directive to be assessed. They must, as far as is relevant for such assessment, cover the design, manufacture and operation of the appliance and contain  as far as is relevant for assessment:  - a general type-description,  - conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,  - descriptions and explanations necessary for the understanding of the drawings and diagrams and the operation of the product,  - a list of the standards referred to in Article 5 (2), applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,  - results of design calculations made, examinations carried out, etc.,  - test reports.  4. The notified body must:  4.1. examine the technical documents, verify that the type has been manufactured in conformity with those documents and identify the elements which have been designed in accordance with the relevant provisions of the standards referred to in Article 5  (2) as well as the components which have been designed without applying the relevant provisions of those standards;  4.2. perform or have performed the appropriate examinations and necessary tests to check whether, where the standards referred to in Article 5 (2) have not been applied, the solutions adopted by the manufacturer meet the essential requirements of the  Directive;  4.3. perform or have performed the appropriate examinations and necessary tests to check whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied;  4.4. agree with the applicant the location where the examinations and necessary tests are to be carried out.  5. Where the type meets the relevant provisions of this Directive, the notified body issues an EC type-examination certificate to the applicant. The certificate contains the name and address of the manufacturer, the conclusion of the examination and  necessary data for identification of the approved type.  A list of the relevant parts of the technical documents is annexed to the certificate and a copy kept by the notified body.  If the manufacturer or his authorized representative established in the Community is refused a type certificate, the notified body must provide detailed reasons for such refusal.  Provision must be made for an appeals procedure.  6. The applicant informs the notified body that holds the technical documents concerning the EC type-examination certificate of all modifications to the approved appliance which must receive additional approval where such changes may affect the  conformity with the essential requirements or the prescribed conditions for use of the product. This additional approval is given in the form of an addition to the original EC type-examination certificate.  7. Each notified body must communicate to the other notified bodies the relevant information concerning the EC type-examination certificates and additions issued and withdrawn.  8. The other notified bodies may receive copies of the EC type-examination certificates and/or their additions. The Annexes to the certificates must be kept at the disposal of the other notified bodies.  9. The manufacturer or his authorized representative established within the Community must keep with the technical documents copies of EC type-examination certificates and their additions for a period of at least 10 years after the last date of  manufacture of the product concerned.  Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documents available is the responsibility of the person who places the product on the Community market.   ANNEX IV Module C: Conformity to type 1. This module describes that part of the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the appliances concerned are in conformity with the type as described in the EC  type-examination certificate and satisfy the requirements of this Directive that apply to them. The manufacturer must affix the CE mark to each appliance and draw up a written declaration of conformity.  2. The manufacturer must take all measures necessary to ensure that the manufacturing process assures the conformity of the manufactured appliances with the type as described in the EC type-examination certificate and with the efficiency requirements of  the Directive.  3. The manufacturer or his authorized representative must keep a copy of the declaration of conformity for a period of at least 10 years after the last date of manufacture of the product concerned.  Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documents available is the responsibility of the person who places the product on the Community market.  4. A notified body chosen by the manufacturer must perform or have performed examinations of the product at random intervals. A suitable sample of the finished products, taken on the spot by the notified body, is examined and appropriate tests, defined  in the applicable standard or standards referred to in Article 5 (2) or equivalent tests are carried out to check the conformity of the product with the requirements of the corresponding Directive. In the event of one or more samples of the products  examined not conforming, the notified body must take the appropriate measures.  Module D: Production quality assurance 1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 2 ensures and declares that the appliances concerned are in conformity with the type as described in the EC type-examination certificate and satisfy  the requirements of this Directive. The manufacturer affixes the CE mark to each appliance and draws up a written declaration of conformity. The CE mark is accompanied by the identification symbol of the notified body responsible for the checks referred  to in section 4.  2. The manufacturer must operate an approved quality system for production, final appliance inspection and testing as specified in section 3. He is subject to the checks referred to in section 4.  3. Quality system 3.1. The manufacturer lodges an application for assessment of his quality system with a notified body of his choice, for the appliances concerned.  The application must include:  - all relevant information for the appliance category envisaged,  - the documents concerning the quality system,  - the technical documents pertaining to the approved type and a copy of the EC type-examination certificate.  3.2. The quality system must ensure conformity of appliances with the type as described in the EC type-examination certificate and with the requirements of this Directive that apply to them.  All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documents must permit a consistent  interpretation of the quality programmes, plans, manuals and quality records.  It must contain in particular an adequate description of:  - the quality objectives and the organizational structure, responsibilities and powers of the management with regard to appliance quality,  - the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,  - the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,  - the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,  - the means of monitoring the achievement of the required appliance quality and the effective operation of the quality system.  3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in section 3.2. It must presume conformity with those requirements in respect of quality systems that implement the relevant harmonized  standard. The auditing team must have at least one member with experience of assessing the relevant product technology. The assessment procedure includes an inspection visit to the manufacturer's premises.  The decision is notified to the manufacturer. The notification must contain the conclusions of the examination and the duly substantiated assessment decision.  3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and maintain it at an adequate and efficient level.  The manufacturer or his authorized representative must keep the notified body that has approved the quality system informed of any proposed change in the quality system. The notified body must assess the changes proposed and decide whether the altered quality system will still satisfy the requirements referred to in 3.2 or whether reassessment in required.  It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the substantiated assessment decision.  4. Monitoring under the responsibility of the notified body 4.1. The purpose of monitoring is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.  4.2. The manufacturer must allow the notified body access for inspection purposes to the manufacturing, inspection, testing and storage premises and provide it with all necessary information, in particular:  - the quality system documents,  - the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.  4.3. The notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and provides an audit report to the manufacturer.  4.4. Additionally the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or have them carried out to verify that the quality system is functioning correctly; if necessary, the notified  body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.  5. The manufacturer must, for a period of at least 10 years after the last date of manufacture of the product, keep at the disposal of the national authorities:  - the document referred to in the second indent of 3.1,  - the updating referred to in the second paragraph of 3.4,  - the decisions and reports from the notified body which are referred to in the final paragraph of 3.4, and in 4.3 and 4.4.  6. Each notified body must give the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.  Module E: Product quality assurance 1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 2 ensures and declares that the boilers and appliances are in conformity with the type as described in the EC type-examination certificate. The  manufacturer must affix the CE mark to each boiler and appliance and draw up a written declaration of conformity. The CE mark must be accompanied by the identification symbol of the notified body responsible for the checks referred to in section 4.  2. The manufacturer must operate an approved quality system for final boiler and appliance inspection and testing as specified in section 3. He must be subject to the checks referred to in section 4.  3. Quality system 3.1. The manufacturer lodges an application with a notified body of this choice for the assessment of the quality system for his boilers and appliances.  The application must include:  - all relevant information for the boiler or appliance category envisaged,  - the quality system's documentation,  - the technical documents pertaining to the approved type and a copy of the EC type-examination certificate.  3.2. Under the quality system, each boiler or appliance is examined and appropriate tests as defined in the relevant standard(s) referred to in Article 5 or equivalent tests are carried out in order to verify its conformity with the relevant  requirements of the Directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system  documentation must enable the quality programmes, plans, manuals and records to be interpreted in a uniform manner.  It must in particular contain an adequate description of:  - the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality,  - the examination and tests that will be carried out after manufacture,  - the means of monitoring the effective operation of the quality system,  - quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.  3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. It must presume conformity with these requirements in respect of quality systems that implement the relevant harmonized  standard.  The auditing team must have at least one member with experience of assessing the relevant product technology. The assessment procedure must include an inspection visit to the manufacturer's premises.  The manufacturer must be notified of the decision. The notification must contain the conclusions of the examination and the substantiated assessment decision.  3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and maintain it at an adequate and efficient level.  The manufacturer or his authorized representative must keep the notified body which has approved the quality system informed of any proposed change in the quality system.  The notified body must assess the changes proposed and decide whether the altered quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required.  It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the substantiated assessment decision.  4. Monitoring under the responsibility of the notified body 4.1. The purpose of monitoring is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.  4.2. The manufacturer must allow the notified body access for inspection purposes to the inspection, testing and storage premises and provide it with all necessary information, in particular:  - the quality system documentation,  - the technical documents,  - the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.  4.3. The notified body must periodically carry out audits to ensure that the manufacturer maintains and applies the quality system and must provide an audit report to the manufacturer.  4.4. Additionally, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or have them carried out to verify that the quality system is functioning correctly; if necessary, the notified  body must provide the manufacturer with a visit report and, if a test has been carried out, with a test report.  5. The manufacturer must, for a period of at least 10 years after the last date of manufacture of the boiler or appliance, keep at the disposal of the national authorities:  - the documents referred to in the third indent of 3.1,  - the changes referred to in the second paragraph of 3.4,  - the decisions and reports from the notified body which are referred to in the final paragraph of 3.4, and in 4.3 and 4.4.  6. Each notified body must forward to the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.   ANNEX V  Minimum criteria to be taken into account by Member States for the notification of bodies  1. The body, its director and the staff responsible for carrying out the verification tests may not be the designer, manufacturer, supplier or installer of  appliances which they inspect, nor the authorized representative of any of those parties. They may not become either involved directly or as authorized representatives in the design, construction, marketing or maintenance of such boilers and appliances.  This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.  2. The body and its staff must carry out the verification tests with the highest degree of professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgment  of the results of the inspection, especially from persons or groups of persons with an interest in the result of verifications.  3. The body must have at its disposal the necessary staff and possess the necessary facilities to enable it to perform properly the administrative and technical tasks connected with verification; it must also have access to the equipment required for  special verification.  4. The staff responsible for inspection must have:  - sound technical and professional training,  - satisfactory knowledge of the requirements of the tests they carry out and adequate experience of such tests,  - the ability to draw up the certificates, records and reports required to authenticate the performance of the tests.  5. The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the number of tests carried out or on the results of such tests.  6. The body must take out liability insurance unless its liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the tests.  7. The staff of the body must be bound to observe professional secrecy (except vis-à-vis the competent administrative authorities of the State in which its activities are carried out) under this Directive or any provision of national law giving effect  to it.


Avis juridique important

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31997L0064

Commission Directive 97/64/EC of 10 November 1997 adapting to technical progress for the fourth time Annex I to Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (lamp oils) (Text with EEA relevance)

Official Journal L 315 , 19/11/1997 P. 0013 - 0014

COMMISSION DIRECTIVE 97/64/EC of 10 November 1997 adapting to technical progress for the fourth time Annex I to Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (lamp oils) (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (1), as last amended by Commission Directive 97/16/EC (2), and in particular Article 2a thereof, introduced by Council Directive 89/678/EEC (3),Whereas Council Directive 89/677/EEC (4) amending for the eighth time Directive 76/769/EEC prohibited the use of certain dangerous substances and preparations in ornamental objects, tricks and jokes, and games;Whereas it has since become known that certain of these dangerous substances and preparations in the form of oils classified as presenting an aspiration hazard, notably when coloured, pose a risk to human health and specifically to the health of young children, especially when used in decorative lamps;Whereas the marketing of such coloured oils for use in decorative lamps should be restricted;Whereas the restrictions on the marketing of such coloured oils laid down by this Directive take into account the current state of knowledge and techniques regarding safer alternatives;Whereas this Directive does not affect Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC (5) and in individual directives based thereon, in particular Council Directive 90/394/EEC (6);Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directives on the removal of technical barriers to trade in dangerous substances and preparations,HAS ADOPTED THIS DIRECTIVE:Article 1 Annex I to Directive 76/769/EEC is hereby adapted to technical progress as set out in the Annex hereto.Article 2 Member States shall adopt and publish the provisions necessary to comply with this Directive by 30 June 1998 at the latest and shall forthwith inform the Commission thereof. They shall apply these provisions as from 31 December 1998.When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.Article 3 This Directive is addressed to the Member States.Done at Brussels, 10 November 1997.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ L 262, 27. 9. 1976, p. 24.(2) OJ L 116, 6. 5. 1997, p. 31.(3) OJ L 398, 30. 12. 1989, p. 24.(4) OJ L 398, 30. 12. 1989, p. 19.(5) OJ L 183, 29. 6. 1989, p. 1.(6) OJ L 196, 26. 7. 1990, p. 1.ANNEX In Annex I to Directive 76/769/EEC, point 3 shall be replaced by the following point:>TABLE>


Avis juridique important

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31997L0081

Council Directive 97/81/EC of 15 December 1997 concerning the Framework Agreement on part-time work concluded by UNICE, CEEP and the ETUC - Annex : Framework agreement on part-time work

Official Journal L 014 , 20/01/1998 P. 0009 - 0014

COUNCIL DIRECTIVE 97/81/EC of 15 December 1997 concerning the Framework Agreement on part-time work concluded by UNICE, CEEP and the ETUCTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Agreement on social policy annexed to the Protocol (No 14) on social policy, annexed to the Treaty establishing the European Community, and in particular Article 4(2) thereof,Having regard to the proposal from the Commission,(1) Whereas on the basis of the Protocol on social policy annexed to the Treaty establishing the European Community, the Member States, with the exception of the United Kingdom of Great Britain and Northern Ireland (hereinafter referred to as 'the Member States`), wishing to continue along the path laid down in the 1989 Social Charter, have concluded an agreement on social policy;(2) Whereas management and labour (the social partners) may, in accordance with Article 4(2) of the Agreement on social policy, request jointly that agreements at Community level be implemented by a Council decision on a proposal from the Commission;(3) Whereas point 7 of the Community Charter of the Fundamental Social Rights of Workers provides, inter alia, that 'the completion of the internal market must lead to an improvement in the living and working conditions of workers in the European Community. This process must result from an approximation of these conditions while the improvement is being maintained, as regards in particular (. . .) forms of employment other than open-ended contracts, such as fixed-term contracts, part-time working, temporary work and seasonal work`;(4) Whereas the Council has not reached a decision on the proposal for a Directive on certain employment relationships with regard to distortions of competition (1), as amended (2), nor on the proposal for a Directive on certain employment relationships with regard to working conditions (3);(5) Whereas the conclusions of the Essen European Council stressed the need to take measures to promote employment and equal opportunities for women and men, and called for measures with a view to increasing the employment-intensiveness of growth, in particular by a more flexible organization of work in a way which fulfils both the wishes of employees and the requirements of competition;(6) Whereas the Commission, in accordance with Article 3(2) of the Agreement on social policy, has consulted management and labour on the possible direction of Community action with regard to flexible working time and job security;(7) Whereas the Commission, considering after such consultation that Community action was desirable, once again consulted management and labour at Community level on the substance of the envisaged proposal in accordance with Article 3(3) of the said Agreement;(8) Whereas the general cross-industry organizations, the Union of Industrial and Employer's Confederations of Europe (UNICE), the European Centre of Enterprises with Public Participation (CEEP) and the European Trade Union Confederation (ETUC) informed the Commission in their joint letter of 19 June 1996 of their desire to initiate the procedure provided for in Article 4 of the Agreement on social policy; whereas they asked the Commission, in a joint letter dated 12 March 1997, for a further three months; whereas the Commission complied with this request;(9) Whereas the said cross-industry organizations concluded, on 6 June 1997, a Framework Agreement on part-time work; whereas they forwarded to the Commission their joint request to implement this Framework Agreement by a Council decision on a proposal from the Commission, in accordance with Article 4(2) of the said Agreement;(10) Whereas the Council, in its Resolution of 6 December 1994 on prospects for a European Union social policy: contribution to economic and social convergence in the Union (4), asked management and labour to make use of the opportunities for concluding agreements, since they are as a rule closer to social reality and to social problems;(11) Whereas the signatory parties wished to conclude a framework agreement on part-time work setting out the general principles and minimum requirements for part-time working; whereas they have demonstrated their desire to establish a general framework for eliminating discrimination against part-time workers and to contribute to developing the potential for part-time work on a basis which is acceptable for employers and workers alike;(12) Whereas the social partners wished to give particular attention to part-time work, while at the same time indicating that it was their intention to consider the need for similar agreements for other flexible forms of work;(13) Whereas, in the conclusions of the Amsterdam European Council, the Heads of State and Government of the European Union strongly welcomed the agreement concluded by the social partners on part-time work;(14) Whereas the proper instrument for implementing the Framework Agreement is a Directive within the meaning of Article 189 of the Treaty; whereas it therefore binds the Member States as to the result to be achieved, whilst leaving national authorities the choice of form and methods;(15) Whereas, in accordance with the principles of subsidiarity and proportionality as set out in Article 3(b) of the Treaty, the objectives of this Directive cannot be sufficiently achieved by the Member States and can therefore be better achieved by the Community; wheres this Directive does not go beyond what is necessary for the attainment of those objectives;(16) Whereas, with regard to terms used in the Framework Agreement which are not specifically defined therein, this Directive leaves Member States free to define those terms in accordance with national law and practice, as is the case for other social policy Directives using similar terms, providing that the said definitions respect the content of the Framework Agreement;(17) Whereas the Commission has drafted its proposal for a Directive, in accordance with its Communication of 14 December 1993 concerning the application of the Protocol (No 14) on social policy and its Communication of 18 September 1996 concerning the development of the social dialogue at Community level, taking into account the representative status of the signatory parties and the legality of each clause of the Framework Agreement;(18) Whereas the Commission has drafted its proposal for a Directive in compliance with Article 2(2) of the Agreement on social policy which provides that Directives in the social policy domain 'shall avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings`;(19) Whereas the Commission, in accordance with its Communication of 14 December 1993 concerning the application of the Protocol (No 14) on social policy, informed the European Parliament by sending it the text of its proposal for a Directive containing the Framework Agreement;(20) Whereas the Commission also informed the Economic and Social Committee;(21) Whereas Clause 6.1 of the Framework Agreement provides that Member States and/or the social partners may maintain or introduce more favourable provisions;(22) Whereas Clause 6.2 of the Framework Agreement provides that implementation of this Directive may not serve to justify any regression in relation to the situation which already exists in each Member State;(23) Whereas the Community Charter of the Fundamental Social Rights of Workers recognizes the importance of the fight against all forms of discrimination, especially based on sex, colour, race, opinion and creed;(24) Whereas Article F(2) of the Treaty on European Union states that the Union shall respect fundamental rights, as guaranteed by the European Convention for the Protection of Human Rights and Fundamental Freedoms and as they result from the constitutional traditions common to the Member States, as general principles of Community law;(25) Whereas the Member States may entrust the social partners, at their joint request, with the implementation of this Directive, provided that the Member States take all the necessary steps to ensure that they can at all times guarantee the results imposed by this Directive;(26) Whereas the implementation of the Framework Agreement contributes to achieving the objectives under Article 1 of the Agreement on social policy,HAS ADOPTED THIS DIRECTIVE:Article 1 The purpose of this Directive is to implement the Framework Agreement on part-time work concluded on 6 June 1997 between the general cross-industry organizations (UNICE, CEEP and the ETUC) annexed hereto.Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 20 January 2000, or shall ensure that, by that date at the latest, the social partners have introduced the necessary measures by agreement, the Member States being required to take any necessary measures to enable them at any time to be in a position to guarantee the results imposed by this Directive. They shall forthwith inform the Commission thereof.Member States may have a maximum of one more year, if necessary, to take account of special difficulties or implementation by a collective agreement.They shall inform the Commission forthwith in such circumstances.When Member States adopt the measures referred to in the first subparagraph, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they have adopted or which they adopt in the field governed by this Directive.Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 15 December 1997.For the CouncilThe PresidentJ.-C. JUNCKER(1) OJ C 224, 8. 9. 1990, p. 6.(2) OJ C 305, 5. 12. 1990, p. 8.(3) OJ C 224, 8. 9. 1990, p. 4.(4) OJ C 368, 23. 12. 1994, p. 6.ANNEX UNION OF INDUSTRIAL AND EMPLOYERS' CONFEDERATIONS OF EUROPE EUROPEAN TRADE UNION CONFEDERATION EUROPEAN CENTRE OF ENTERPRISES WITH PUBLIC PARTICIPATION FRAMEWORK AGREEMENT ON PART-TIME WORK PreambleThis Framework Agreement is a contribution to the overall European strategy on employment. Part-time work has had an important impact on employment in recent years. For this reason, the parties to this agreement have given priority attention to this form of work. It is the intention of the parties to consider the need for similar agreements relating to other forms of flexible work.Recognizing the diversity of situations in Member States and acknowledging that part-time work is a feature of employment in certain sectors and activities, this Agreement sets out the general principles and minimum requirements relating to part-time work. It illustrates the willingness of the social partners to establish a general framework for the elimination of discrimination against part-time workers and to assist the development of opportunities for part-time working on a basis acceptable to employers and workers.This Agreement relates to employment conditions of part-time workers recognizing that matters concerning statutory social security are for decision by the Member States. In the context of the principle of non-discrimination, the parties to this Agreement have noted the Employment Declaration of the Dublin European Council of December 1996, wherein the Council inter alia emphasized the need to make social security systems more employment-friendly by 'developing social protection systems capable of adapting to new patterns of work and of providing appropriate protection to people engaged in such work`. The parties to this Agreement consider that effect should be given to this Declaration.ETUC, UNICE and CEEP request the Commission to submit this Framework Agreement to the Council for a decision making these requirements binding in the Member States which are party to the Agreement on social policy annexed to the Protocol (No 14) on social policy annexed to the Treaty establishing the European Community.The parties to this Agreement ask the Commission, in its proposal to implement this Agreement, to request that Member States adopt the laws, regulations and administrative provisions necessary to comply with the Council decision within a period of two years from its adoption or ensure (1) that the social partners establish the necessary measures by way of agreement by the end of this period. Member States may, if necessary to take account of particular difficulties or implementation by collective agreement, have up to a maximum of one additional year to comply with this provision.Without prejudice to the role of national courts and the Court of Justice, the parties to this agreement request that any matter relating to the interpretation of this agreement at European level should, in the first instance, be referred by the Commission to them for an opinion.General considerations1. Having regard to the Agreement on social policy annexed to the Protocol (No 14) on social policy annexed to the Treaty establishing the European Community, and in particular Articles 3(4) and 4(2) thereof;2. Whereas Article 4(2) of the Agreement on social policy provides that agreements concluded at Community level may be implemented, at the joint request of the signatory parties, by a Council decision on a proposal from the Commission.3. Whereas, in its second consultation document on flexibility of working time and security for workers, the Commission announced its intention to propose a legally binding Community measure;4. Whereas the conclusions of the European Council meeting in Essen emphasized the need for measures to promote both employment and equal opportunities for women and men, and called for measures aimed at 'increasing the employment intensiveness of growth, in particular by more flexible organization of work in a way which fulfils both the wishes of employees and the requirements of competition`;5. Whereas the parties to this agreement attach importance to measures which would facilitate access to part-time work for men and women in order to prepare for retirement, reconcile professional and family life, and take up education and training opportunities to improve their skills and career opportunities for the mutual benefit of employers and workers and in a manner which would assist the development of enterprises;6. Whereas this Agreement refers back to Member States and social partners for the arrangements for the application of these general principles, minimum requirements and provisions, in order to take account of the situation in each Member State;7. Whereas this Agreement takes into consideration the need to improve social policy requirements, to enhance the competitiveness of the Community economy and to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings;8. Whereas the social partners are best placed to find solutions that correspond to the needs of both employers and workers and must therefore be given a special role in the implementation and application of this Agreement.THE SIGNATORY PARTIES HAVE AGREED THE FOLLOWING:Clause 1: PurposeThe purpose of this Framework Agreement is:(a) to provide for the removal of discrimination against part-time workers and to improve the quality of part-time work;(b) to facilitate the development of part-time work on a voluntary basis and to contribute to the flexible organization of working time in a manner which takes into account the needs of employers and workers.Clause 2: Scope1. This Agreement applies to part-time workers who have an employment contract or employment relationship as defined by the law, collective agreement or practice in force in each Member State.2. Member States, after consultation with the social partners in accordance with national law, collective agreements or practice, and/or the social partners at the appropriate level in conformity with national industrial relations practice may, for objective reasons, exclude wholly or partly from the terms of this Agreement part-time workers who work on a casual basis. Such exclusions should be reviewed periodically to establish if the objective reasons for making them remain valid.Clause 3: DefinitionsFor the purpose of this agreement:1. The term 'part-time worker` refers to an employee whose normal hours of work, calculated on a weekly basis or on average over a period of employment of up to one year, are less than the normal hours of work of a comparable full-time worker.2. The term 'comparable full-time worker` means a full-time worker in the same establishment having the same type of employment contract or relationship, who is engaged in the same or a similar work/occupation, due regard being given to other considerations which may include seniority and qualification/skills.Where there is no comparable full-time worker in the same establishment, the comparison shall be made by reference to the applicable collective agreement or, where there is no applicable collective agreement, in accordance with national law, collective agreements or practice.Clause 4: Principle of non-discrimination1. In respect of employment conditions, part-time workers shall not be treated in a less favourable manner than comparable full-time workers solely because they work part time unless different treatment is justified on objective grounds.2. Where appropriate, the principle of pro rata temporis shall apply.3. The arrangements for the application of this clause shall be defined by the Member States and/or social partners, having regard to European legislation, national law, collective agreements and practice.4. Where justified by objective reasons, Member States after consultation of the social partners in accordance with national law, collective agreements or practice and/or social partners may, where appropriate, make access to particular conditions of employment subject to a period of service, time worked or earnings qualification. Qualifications relating to access by part-time workers to particular conditions of employment should be reviewed periodically having regard to the principle of non-discrimination as expressed in Clause 4.1.Clause 5: Opportunities for part-time work1. In the context of Clause 1 of this Agreement and of the principle of non-discrimination between part-time and full-time workers:(a) Member States, following consultations with the social partners in accordance with national law or practice, should identify and review obstacles of a legal or administrative nature which may limit the opportunities for part-time work and, where appropriate, eliminate them;(b) the social partners, acting within their sphere of competence and through the procedures set out in collective agreements, should identify and review obstacles which may limit opportunities for part-time work and, where appropriate, eliminate them.2. A worker's refusal to transfer from full-time to part-time work or vice-versa should not in itself constitute a valid reason for termination of employment, without prejudice to termination in accordance with national law, collective agreements and practice, for other reasons such as may arise from the operational requirements of the establishment concerned.3. As far as possible, employers should give consideration to:(a) requests by workers to transfer from full-time to part-time work that becomes available in the establishment;(b) requests by workers to transfer from part-time to full-time work or to increase their working time should the opportunity arise;(c) the provision of timely information on the availability of part-time and full-time positions in the establishment in order to facilitate transfers from full-time to part-time or vice versa;(d) measures to facilitate access to part-time work at all levels of the enterprise, including skilled and managerial positions, and where appropriate, to facilitate access by part-time workers to vocational training to enhance career opportunities and occupational mobility;(e) the provision of appropriate information to existing bodies representing workers about part-time working in the enterprise.Clause 6: Provisions on implementation1. Member States and/or social partners may maintain or introduce more favourable provisions than set out in this agreement.2. Implementation of the provisions of this Agreement shall not constitute valid grounds for reducing the general level of protection afforded to workers in the field of this agreement. This does not prejudice the right of Member States and/or social partners to develop different legislative, regulatory or contractual provisions, in the light of changing circumstances, and does not prejudice the application of Clause 5.1 as long as the principle of non-discrimination as expressed in Clause 4.1 is complied with.3. This Agreement does not prejudice the right of the social partners to conclude, at the appropriate level, including European level, agreements adapting and/or complementing the provisions of this Agreement in a manner which will take account of the specific needs of the social partners concerned.4. This Agreement shall be without prejudice to any more specific Community provisions, and in particular Community provisions concerning equal treatment or opportunities for men and women.5. The prevention and settlement of disputes and grievances arising from the application of this Agreement shall be dealt with in accordance with national law, collective agreements and practice.6. The signatory parties shall review this Agreement, five years after the date of the Council decision, if requested by one of the parties to this Agreement.(1) Within the meaning of Article 2(4) of the Agreement on social policy of the Treaty establishing the European Community.


title: Commission Directive 2011/8/EU of 28 January 2011 amending Directive 2002/72/EC as regards the restriction of use of Bisphenol A in plastic infant feeding bottles  Text with EEA relevance

text:
               29.1.2011

               EN

               Official Journal of the European Union

               L 26/11

         COMMISSION DIRECTIVE 2011/8/EU
   of 28 January 2011
   amending Directive 2002/72/EC as regards the restriction of use of Bisphenol A in plastic infant feeding bottles
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), and in particular Article 18(3) thereof,
   After consulting the European Food Safety Authority,
   Whereas:

               (1)

               Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (2) authorises the use of 2,2-bis(4-hydroxyphenyl)propane, commonly known as Bisphenol A (hereinafter ‘BPA’), as monomer for the manufacture of plastic materials and articles intended to come into contact with foodstuffs in accordance with the opinions of the Scientific Committee on Food (hereinafter ‘SCF’) (3) and the European Food Safety Authority (hereinafter ‘the EFSA’) (4).

               (2)

               BPA is used as monomer in the manufacture of polycarbonate plastics. Polycarbonate plastics are used amongst others in the manufacture of infant feeding bottles. When heated under certain conditions small amounts of BPA can potentially leach out from food containers into foods and beverages and be ingested.

               (3)

               On 29 March 2010 the Danish Government informed the Commission and the Member States that it has decided to apply the safeguard measures provided for in Article 18 of Regulation (EC) No 1935/2004 and to temporarily ban the use of BPA for the manufacture of plastic materials in contact with food intended for children aged 0-3 (5).

               (4)

               The Danish Government substantiated its safeguard measure with a risk assessment provided on 22 March 2010 by the National Food Institute at the Technical University of Denmark (hereinafter ‘DTU Food’). The risk assessment covers the evaluation of a comprehensive study carried out on animals exposed to BPA in low doses monitoring the development of the nervous system and the behaviour in newborn rats. DTU Food has also evaluated whether the new data changes its previous evaluation of the toxic effects on the development of the nervous system and behaviour possibly caused by BPA.

               (5)

               In accordance with the procedure provided for in Article 18 of Regulation (EC) No 1935/2004 on 30 March 2010 the Commission asked the EFSA to give its opinion on the grounds adduced by Denmark for concluding that the use of the material endangers human health, although it complies with the relevant specific measures.

               (6)

               On 6 July 2010 the French Government informed the Commission, and on 9 July 2010 the Member States, that it has decided to apply the safeguard measures provided for in Article 18 of Regulation (EC) No 1935/2004 and to temporarily ban the manufacture, import, export and placing on the market of feeding bottles containing BPA (6).

               (7)

               The French Government substantiated its safeguard measure with two opinions issued by the French Food Safety Authority (AFSSA) on 29 January and 7 June 2010 and the report published on 3 June 2010 by the National Institute of Health and Medical Research (INSERM).

               (8)

               On 23 September 2010 the EFSA adopted the opinion of its Panel on food contact materials, enzymes, flavourings and processing aids (hereinafter ‘the Panel’) on BPA responding to the Commission’s request of 30 March 2010 as well as covering the evaluation of the specific neurobehavioural study evaluated in the Danish risk assessment and the review and evaluation of other recently published studies on BPA (7).

               (9)

               In its opinion the Panel concludes that based on the comprehensive evaluation of recent human and animal toxicity data, no new study could be identified, which would call for a revision of the current tolerable daily intake (hereinafter ‘TDI’) of 0,05 mg/kg bodyweight per day. This TDI is based on the no adverse effect level of 5 mg/kg bodyweight per day from a multi-generation reproductive toxicity study in rats, and the application of an uncertainty factor of 100, which is considered as conservative based on all information on BPA toxicokinetics. However, in a minority opinion one Member of the Panel concluded that the effects observed in certain studies raised uncertainties which may not be covered by the current TDI which should therefore be considered temporary until more robust data becomes available in the areas of uncertainty.

               (10)

               The Panel noted that some animal studies conducted on developing animals have suggested other BPA-related effects of possible toxicological relevance, in particular biochemical changes in brain, immune-modulatory effects and enhanced susceptibility to breast tumours. These studies have many shortcomings. The relevance of these findings in relation to human health cannot be assessed at present. In case any new relevant data becomes available in the future, the Panel will reconsider its opinion.

               (11)

               Infant formula or breast milk is the only source of nutrition for infants up to the age of 4 months, and it remains the major source of nutrition for some additional months. In its opinion of 2006 the EFSA concluded that infants aged 3 and 6 months fed using polycarbonate infant feeding bottles have the highest exposure to BPA, though below the TDI. For this group of infants the level of exposure to BPA decreases once feeding from polycarbonate bottles is phased out and other sources of nutrition become dominant.

               (12)

               Even if the infant has sufficient capacity to eliminate BPA at worst-case exposure the EFSA opinion pointed out that an infant’s system to eliminate BPA is not as developed as that of an adult and it only gradually reaches the adult capacity during the first 6 months.

               (13)

               The potential toxicological effects may have a higher impact in the developing organism. According to the opinions of the Scientific Committee on Food of 1997 (8) and 1998 (9) certain effects, in particular endocrine and reproductive effects, effects on the immune system and the neurodevelopment are of particular relevance to infants. Reproductive effects and neurodevelopmental effects of BPA have been studied extensively in standard multigeneration toxicological tests and in other studies, which took account of the developing organism and did not reveal effects in doses below the TDI. However, studies which could not be taken into account for setting the TDI due to many shortcomings showed BPA-related effects of possible toxicological relevance. These effects, in particular those on the biochemical changes in the brain, which may affect neurodevelopment, and on immune modulation are reflecting the area of particular concern for infants highlighted in the SCF opinions of 1997 and 1998. In addition, the EFSA opinion of 2010 mentions the enhancing effect of an early exposure to BPA on tumour formation later on in life when exposed to a carcinogen. Also in this case the sensitive stage is the developing organism. Thus the infant can be identified as the particular vulnerable part of the population as regards those findings for which the relevance for human health could not yet be fully assessed.

               (14)

               According to the EFSA opinion of 2006 polycarbonate feeding bottles is the main source of exposure to BPA for infants. Alternative materials to polycarbonate that do not contain BPA exist on the EU market, in particular glass and other plastic infant feeding bottles. These alternative materials have to comply with the strict safety requirements set out for food contact materials. Therefore, it is not necessary to continue the use of BPA-containing polycarbonate for infant feeding bottles.

               (15)

               Given that there exists a possible particular vulnerability of infants to potential effects of BPA, although also the infant is deemed to be able to eliminate BPA and even where the risk, notably to human health, has not yet been fully demonstrated, it is appropriate to reduce their exposure to BPA as much as reasonably achievable, until further scientific data is available to clarify the toxicological relevance of some observed effects of BPA, in particular as regards biochemical changes in brain, immune-modulatory effects and enhanced susceptibility to breast tumours.

               (16)

               The precautionary principle referred to in Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (10) allows the Union to provisionally adopt measures on the basis of available pertinent information, pending an additional assessment of risk and a review of the measure within a reasonable period of time.

               (17)

               Taking into account that there are uncertainties in the present state of scientific research with regard to the harmfulness of BPA exposure to infants (11) through polycarbonate infant feeding bottles that would need to be clarified, the Commission is entitled to take a preventive measure regarding the use of BPA in polycarbonate infant feeding bottles on the basis of the precautionary principle which is applicable in a situation in which there is scientific uncertainty, even if the risk, notably to human health, has not yet been fully demonstrated.

               (18)

               Thus, it is necessary and appropriate for the achievement of the basic objective of ensuring a high level of human health protection to obviate sources of danger to physical and mental health that may be caused to infants by BPA exposure through feeding bottles.

               (19)

               The Commission evaluated the infant feeding bottle market and received an indication by the relevant producers that voluntary action by the industry for replacements on the market are ongoing and the economic impact of the proposed measure is limited. Therefore, all BPA-containing infant feeding bottles on the EU market should be replaced by the middle of 2011.

               (20)

               Until further scientific data are available to clarify the toxicological relevance of some observed effects of BPA, in particular as regards biochemical changes in brain, immune-modulatory effects and enhanced susceptibility to breast tumours, the use of BPA in the manufacture and placing on the market of polycarbonate infant feeding bottles should be temporarily banned. Directive 2002/72/EC should therefore be amended accordingly. The Authority has a mandate to monitor new studies to clarify these endpoints.

               (21)

               Following the evaluation of the technical and economic feasibility to implement the proposed measure it is concluded that the measure is no more restrictive of trade than is required to achieve the high level of health protection chosen in the Union.

               (22)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Annex II, Section A of Directive 2002/72/EC, the text in column 4 under the reference number 13480 as regards the monomer 2,2-bis(4-hydroxyphenyl)propane is replaced by the following:

      ‘SML (T) = 0,6 mg/kg. Not to be used for the manufacture of polycarbonate infant (12) feeding bottles

   Article 2
   1.   Member States shall adopt and publish, by 15 February 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt the provisions referred to in paragraph 1, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall apply the provisions referred to in paragraph 1 in such a way as to prohibit from 1 March 2011 the manufacture of, and from 1 June 2011 the placing on the market and importation into the Union of, plastic materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive.
   3.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on 1 February 2011.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 28 January 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 338, 13.11.2004, p. 4.

      (2)  OJ L 220, 15.8.2002, p. 18.

      (3)  Opinion of the Scientific Committee on Food on Bisphenol A, expressed on 17 April 2002. SCF/CS/PM/3936 Final, 3 May 2002. http://ec.europa.eu/food/fs/sc/scf/out128_en.pdf

      (4)  Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to 2,2-BIS(4-HYDROXYPHENYL)PROPANE (Bisphenol A) Question number EFSA-Q-2005-100, Adopted on 29 November 2006, The EFSA Journal (2006) 428, p. 1. and Toxicokinetics of Bisphenol A, Scientific Opinion of the Panel on Food additives, Flavourings, Processing aids and Materials in Contact with Food (AFC) (Question No EFSA-Q-2008-382) Adopted on 9 July 2008, The EFSA Journal (2008) 759, p. 1.

      (5)  Bekendtgørelse om ændring af bekendtgørelse om materialer og genstande bestemt til kontakt med fødevarer, Lovtidende A, Nr. 286, 27.3.2010.

      (6)  LOI no 2010-729 du 30 juin 2010 tendant à suspendre la commercialisation de biberons produits à base de bisphénol A, JORF no 0150 du 1 juillet 2010, page 11857.

      (7)  Scientific Opinion on Bisphenol A: evaluation of a study investigating its neurodevelopmental toxicity, review of recent scientific literature on its toxicity and advice on the Danish risk assessment of Bisphenol A EFSA Panel on food contact materials, enzymes, flavourings and processing aids (CEF) (Question Nos: EFSA-Q-2009-00864, EFSA-Q-2010-01023 and EFSA-Q-2010-00709) adopted on 23 September 2010, EFSA Journal 2010; 8(9):1829.

      (8)  Opinion of the Scientific Committee for Food on: A maximum residue limit (MRL) of 0,01 mg/kg for pesticides in foods intended for infants and young children (expressed on 19 September 1997).

      (9)  Further advice on the opinion of the Scientific Committee for Food expressed on 19 September 1997 on a Maximum Residue Limit (MRL) of 0,01 mg/kg for pesticides in foods intended for infants and young children (adopted by the SCF on 4 June 1998).

      (10)  OJ L 31, 1.2.2002, p. 1.

      (11)  As defined in Commission Directive 2006/141/EC (OJ L 401, 30.12.2006, p. 1).

      (12)  Infant as defined in Directive 2006/141/EC (OJ L 401, 30.12.2006, p. 1).’