4.2.2006 EN Official Journal of the European Union L 33/1 REGULATION (EC) No 166/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 January 2006 concerning the establishment of a European Pollutant Release and Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) The Sixth Community Environment Action Programme adopted by Decision No 1600/2002/EC of the European Parliament and of the Council (3) requires supporting the provision of accessible information to citizens on the state and trends of the environment in relation to social, economic and health trends as well as the general raising of environmental awareness. (2) The UNECE Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (hereinafter ‘the Aarhus Convention’), signed by the European Community on 25 June 1998, recognises that increased public access to environmental information and the dissemination of such information contribute to a greater awareness of environmental matters, a free exchange of views, more effective participation by the public in environmental decision-making and, eventually, to a better environment. (3) Pollutant release and transfer registers (hereinafter ‘PRTRs’) are a cost-effective tool for encouraging improvements in environmental performance, for providing public access to information on releases of pollutants and off-site transfers of pollutants and waste, and for use in tracking trends, demonstrating progress in pollution reduction, monitoring compliance with certain international agreements, setting priorities and evaluating progress achieved through Community and national environmental policies and programmes. (4) An integrated and coherent PRTR gives the public, industry, scientists, insurance companies, local authorities, non-governmental organisations and other decision-makers a solid database for comparisons and future decisions in environmental matters. (5) On 21 May 2003 the European Community signed the UNECE Protocol on Pollutant Release and Transfer Registers (hereinafter ‘the Protocol’). Provisions of Community law should be consistent with that Protocol with a view to its conclusion by the Community. (6) A European Pollutant Emission Register (hereinafter ‘EPER’) was established by Commission Decision 2000/479/EC (4). The Protocol builds on the same principles as EPER, but goes beyond, by including reporting on more pollutants, more activities, releases to land, releases from diffuse sources and off-site transfers. (7) The objectives and goals pursued by a European PRTR can only be achieved if data are reliable and comparable. An adequate harmonisation of the data collection and transfer system is therefore needed to ensure the quality and comparability of data. In accordance with the Protocol the European PRTR should be designed for maximum ease of public access through the Internet. Releases and transfers should be easily identified in different aggregated and non-aggregated forms in order to access a maximum of information in a reasonable time. (8) In order to further promote the objective of supporting the provision of accessible information to citizens on the state and trends of the environment as well as the general raising of environmental awareness, the European PRTR should contain links to other similar databases in Member States, non-Member States and international organisations. (9) In accordance with the Protocol, the European PRTR should also contain information on specific waste disposal operations, to be reported as releases to land; recovery operations such as sludge and manure spreading are not reported under this category. (10) In order to achieve the objective of the European PRTR to provide reliable information to the public and to allow for knowledge-based decisions it is necessary to provide for reasonable but strict timeframes for data collection and reporting; this is particularly relevant for reporting by Member States to the Commission. (11) Reporting of releases from industrial facilities, although not yet always consistent, complete and comparable, is a well established procedure in many Member States. Where appropriate, reporting on releases from diffuse sources should be improved in order to enable decision-makers to better put into context those releases and to choose the most effective solution for pollution reduction. (12) Data reported by the Member States should be of high quality in particular as regards their completeness, consistency and credibility. It is of great importance to coordinate future efforts of both operators and Member States to improve the quality of the reported data. The Commission will therefore initiate work, together with the Member States, on quality assurance. (13) In accordance with the Aarhus Convention, the public should be granted access to the information contained in the European PRTR without an interest to be stated, primarily by ensuring that the European PRTR provides for direct electronic access through the Internet. (14) Access to information provided by the European PRTR should be unrestricted and exceptions from this rule should only be possible where explicitly granted by existing Community legislation. (15) In accordance with the Aarhus Convention, public participation should be ensured in the further development of the European PRTR by early and effective opportunities to submit comments, information, analysis or relevant opinions for the decision-making process. Applicants should be able to seek an administrative or judicial review of the acts or omissions of a public authority in relation to a request. (16) In order to enhance the usefulness and impact of the European PRTR, the Commission and the Member States should cooperate in developing guidance supporting the implementation of the European PRTR, in promoting awareness of the public and in providing appropriate and timely technical assistance. (17) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5). (18) Since the objective of the action to be taken, namely to enhance public access to environmental information through the establishment of an integrated, coherent Community-wide electronic database, cannot be sufficiently achieved by the Member States, because the need for comparability of data throughout the Member States argues for a high level of harmonisation, and can therefore be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (19) In order to simplify and streamline reporting requirements, Council Directive 91/689/EEC of 12 December 1991 on hazardous waste (6) and Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (7) should be amended. (20) The European PRTR aims, among other things, at informing the public about important pollutant emissions due, in particular, to activities covered by Directive 96/61/EC. Consequently, under this Regulation, information should be provided to the public on emissions from installations covered by Annex I of that Directive. (21) To reduce duplicate reporting, pollutant release and transfer register systems may, under the Protocol, be integrated to the degree practicable with existing information sources such as reporting mechanisms under licences or operating permits. In accordance with the Protocol, the provisions of this Regulation should not affect the right of the Member States to maintain or introduce a more extensive or more publicly accessible pollutant release and transfer register than required under the Protocol, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes an integrated pollutant release and transfer register at Community level (hereinafter ‘the European PRTR’) in the form of a publicly accessible electronic database and lays down rules for its functioning, in order to implement the UNECE Protocol on Pollutant Release and Transfer Registers (hereinafter ‘the Protocol’) and facilitate public participation in environmental decision-making, as well as contributing to the prevention and reduction of pollution of the environment. Article 2 Definitions For the purposes of this Regulation the following definitions shall apply: (1) ‘the public’ means one or more natural or legal persons, and, in accordance with national legislation or practice, their associations, organisations or groups; (2) ‘competent authority’ means the national authority or authorities, or any other competent body or bodies, designated by the Member States; (3) ‘installation’ means a stationary technical unit where one or more activities listed in Annex I are carried out, and any other directly associated activities which have a technical connection with the activities carried out on that site and which could have an effect on emissions and pollution; (4) ‘facility’ means one or more installations on the same site that are operated by the same natural or legal person; (5) ‘site’ means the geographical location of the facility; (6) ‘operator’ means any natural or legal person who operates or controls the facility or, where this is provided for in national legislation, to whom decisive economic power over the technical functioning of the facility has been delegated; (7) ‘reporting year’ means the calendar year for which data on releases of pollutants and off-site transfers must be gathered; (8) ‘substance’ means any chemical element and its compounds, with the exception of radioactive substances; (9) ‘pollutant’ means a substance or a group of substances that may be harmful to the environment or to human health on account of its properties and of its introduction into the environment; (10) ‘release’ means any introduction of pollutants into the environment as a result of any human activity, whether deliberate or accidental, routine or non-routine, including spilling, emitting, discharging, injecting, disposing or dumping, or through sewer systems without final waste-water treatment; (11) ‘off-site transfer’ means the movement beyond the boundaries of a facility of waste destined for recovery or disposal and of pollutants in waste water destined for waste-water treatment; (12) ‘diffuse sources’ means the many smaller or scattered sources from which pollutants may be released to land, air or water, whose combined impact on those media may be significant and for which it is impractical to collect reports from each individual source; (13) ‘waste’ means any substance or object as defined in Article 1(a) of Council Directive 75/442/EEC of 15 July 1975 on waste (8); (14) ‘hazardous waste’ means any substance or object as defined in Article 1(4) of Directive 91/689/EEC; (15) ‘waste water’ means urban, domestic and industrial waste water, as defined in Article 2(1), (2) and (3) of Council Directive 91/271/EEC of 21 May 1991 concerning urban waste water treatment (9), and any other used water which is subject, because of the substances or objects it contains, to regulation by Community law; (16) ‘disposal’ means any of the operations provided for in Annex IIA to Directive 75/442/EEC; (17) ‘recovery’ means any of the operations provided for in Annex IIB to Directive 75/442/EEC. Article 3 Content of the European PRTR The European PRTR shall include information on: (a) releases of pollutants referred to in Article 5(1)(a) that must be reported by the operators of the facilities carrying out the activities listed in Annex I; (b) off-site transfers of waste referred to in Article 5(1)(b) and of pollutants in waste water referred to in Article 5(1)(c), that must be reported by the operators of the facilities carrying out the activities listed in Annex I; (c) releases of pollutants from diffuse sources referred to in Article 8(1), where available. Article 4 Design and structure 1. The Commission shall publish the European PRTR, presenting the data in both aggregated and non-aggregated forms, so that releases and transfers can be searched for and identified by: (a) facility, including the facility's parent company where applicable, and its geographical location, including the river basin; (b) activity; (c) occurrence at Member State or Community level; (d) pollutant or waste, as appropriate; (e) each environmental medium (air, water, land) into which the pollutant is released; (f) off-site transfers of waste and their destination, as appropriate; (g) off-site transfers of pollutants in waste water; (h) diffuse sources; (i) facility owner or operator. 2. The European PRTR shall be designed for maximum ease of public access to allow the information, under normal operating conditions, to be continuously and readily accessible on the Internet and by other electronic means. Its design shall take into account the possibility of its future expansion and shall include all data reported for previous reporting years, up to at least the last ten previous reporting years. 3. The European PRTR shall include links to the following: (a) the national PRTRs of Member States; (b) other relevant existing, publicly accessible databases on subject matters related to PRTRs, including national PRTRs of other Parties to the Protocol and, where feasible, those of other countries; (c) facilities' websites if they exist and links are volunteered by the facilities. Article 5 Reporting by operators 1. The operator of each facility that undertakes one or more of the activities specified in Annex I above the applicable capacity thresholds specified therein shall report the amounts annually to its competent authority, along with an indication of whether the information is based on measurement, calculation or estimation, of the following: (a) releases to air, water and land of any pollutant specified in Annex II for which the applicable threshold value specified in Annex II is exceeded; (b) off-site transfers of hazardous waste exceeding 2 tonnes per year or of non hazardous waste exceeding 2 000 tonnes per year, for any operations of recovery or disposal with the exception of the disposal operations of land treatment and deep injection referred to in Article 6, indicating with ‘R’ or ‘D’ respectively whether the waste is destined for recovery or disposal and, for transboundary movements of hazardous waste, the name and address of the recoverer or the disposer of the waste and the actual recovery or disposal site; (c) off-site transfers of any pollutant specified in Annex II in waste water destined for waste-water treatment for which the threshold value specified in Annex II, column 1b is exceeded. The operator of each facility that undertakes one or more of the activities specified in Annex I above the applicable capacity thresholds specified therein shall communicate to its competent authority the information identifying the facility in accordance with Annex III unless that information is already available to the competent authority. In the case of data indicated as being based on measurement or calculation the analytical method and/or the method of calculation shall be reported. The releases referred to in Annex II reported under point (a) of this paragraph shall include all releases from all sources included in Annex I at the site of the facility. 2. The information referred to in paragraph 1 shall include information on releases and transfers resulting as totals of all deliberate, accidental, routine and non-routine activities. In providing this information operators shall specify, where available, any data that relate to accidental releases. 3. The operator of each facility shall collect with appropriate frequency the information needed to determine which of the facility's releases and off-site transfers are subject to reporting requirements under paragraph 1. 4. When preparing the report, the operator concerned shall use the best available information, which may include monitoring data, emission factors, mass balance equations, indirect monitoring or other calculations, engineering judgements and other methods in line with Article 9(1) and in accordance with internationally approved methodologies, where these are available. 5. The operator of each facility concerned shall keep available for the competent authorities of the Member State the records of the data from which the reported information was derived for a period of five years, starting from the end of the reporting year concerned. These records shall also describe the methodology used for data gathering. Article 6 Releases to land Waste which is subject to ‘land treatment’ or ‘deep injection’ disposal operations, as specified in Annex IIA to Directive 75/442/EEC, shall be reported as a release to land only by the operator of the facility originating the waste. Article 7 Reporting by Member States 1. The Member States shall determine, having regard to the requirements set out in paragraphs 2 and 3 of this Article, a date by which operators shall provide all the data referred to in Article 5(1) and (2) and the information referred to in Article 5(3), (4) and (5) to its competent authority. 2. Member States shall provide all the data referred to in Article 5(1) and (2) to the Commission by electronic transfer in the format set out in Annex III and within the following time-limits: (a) for the first reporting year, within 18 months after the end of the reporting year; (b) for all reporting years thereafter, within 15 months after the end of the reporting year. The first reporting year shall be the year 2007. 3. The Commission, assisted by the European Environment Agency, shall incorporate the information reported by the Member States into the European PRTR within the following time-limits: (a) for the first reporting year, within 21 months after the end of the reporting year; (b) for all reporting years thereafter, within 16 months after the end of the reporting year. Article 8 Releases from diffuse sources 1. The Commission, assisted by the European Environment Agency, shall include in the European PRTR information on releases from diffuse sources where such information exists and has already been reported by the Member States. 2. The information referred to in paragraph 1 shall be organised such as to allow users to search for and identify releases of pollutants from diffuse sources according to an adequate geographical disaggregation and shall include information on the type of methodology used to derive the information. 3. Where the Commission determines that no data on the releases from diffuse sources exist, it shall take measures to initiate reporting on releases of relevant pollutants from one or more diffuse sources in accordance with the procedure referred to in Article 19(2), using internationally approved methodologies where appropriate. Article 9 Quality assurance and assessment 1. The operator of each facility subject to the reporting requirements set out in Article 5 shall assure the quality of the information that they report. 2. The competent authorities shall assess the quality of the data provided by the operators of the facilities referred to in paragraph 1, in particular as to their completeness, consistency and credibility. 3. The Commission shall coordinate work on quality assurance and quality assessment in consultation with the Committee referred to in Article 19(1). 4. The Commission may adopt guidelines for the monitoring and reporting of emissions in accordance with the procedure referred to in Article 19(2). These guidelines shall be in accordance with internationally approved methodologies, where appropriate, and shall be consistent with other Community legislation. Article 10 Access to information 1. The Commission, assisted by the European Environment Agency, shall make the European PRTR publicly accessible by dissemination free of charge on the Internet in accordance with the timeframe set out in Article 7(3). 2. Where the information contained in the European PRTR is not easily accessible to the public by direct electronic means, the Member State concerned and the Commission shall facilitate electronic access to the European PRTR in publicly accessible locations. Article 11 Confidentiality Whenever information is kept confidential by a Member State in accordance with Article 4 of Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (10), the Member State shall, in its report under Article 7(2) of this Regulation for the reporting year concerned, indicate separately for each facility claiming confidentiality the type of information that has been withheld and the reason for which it has been withheld. Article 12 Public participation 1. The Commission shall provide the public with early and effective opportunities to participate in the further development of the European PRTR, including capacity-building and the preparation of amendments to this Regulation. 2. The public shall have the opportunity to submit any relevant comments, information, analyses or opinions within a reasonable timeframe. 3. The Commission shall take due account of such input and shall inform the public about the outcome of the public participation. Article 13 Access to justice Access to justice in matters relating to public access to environmental information shall be ensured in accordance with Article 6 of Directive 2003/4/EC and, where the institutions of the Community are involved, in accordance with Articles 6, 7 and 8 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (11). Article 14 Guidance document 1. The Commission shall draw up a guidance document supporting the implementation of the European PRTR as soon as possible but no later than four months before the beginning of the first reporting year and in consultation with the Committee referred to in Article 19(1). 2. The guidance document for implementation of the European PRTR shall address in particular details on the following: (a) reporting procedures; (b) the data to be reported; (c) quality assurance and assessment; (d) indication of type of withheld data and reasons why they were withheld in the case of confidential data; (e) reference to internationally approved release determination and analytical methods, sampling methodologies; (f) indication of parent companies; (g) coding of activities according to Annex I to this Regulation and to Directive 96/61/EC. Article 15 Awareness raising The Commission and the Member States shall promote awareness of the public of the European PRTR and shall ensure that assistance is provided in accessing the European PRTR and in understanding and using the information contained in it. Article 16 Additional information to be reported by the Member States 1. Member States shall, in a single report based on the information from the last three reporting years to be delivered every three years together with the data provided in accordance with Article 7, inform the Commission on practice and measures taken regarding the following: (a) requirements according to Article 5; (b) quality assurance and assessment according to Article 9; (c) access to information according to Article 10(2); (d) awareness raising activities according to Article 15; (e) confidentiality of information according to Article 11; (f) penalties provided for according to Article 20 and experience with their application. 2. To facilitate the reporting by Member States referred to in paragraph 1 the Commission shall submit a proposal for a questionnaire, which shall be adopted in accordance with the procedure referred to in Article 19(2). Article 17 Review by the Commission 1. The Commission shall review the information provided by Member States according to Article 7 and after consultation with the Member States shall publish a report every three years based on the information from the last three reporting years available, six months after the presentation of this information on the Internet. 2. This report shall be submitted to the European Parliament and the Council, together with an assessment of the operation of the European PRTR. Article 18 Amendments to the Annexes Any amendment necessary for adapting: (a) Annexes II or III to this Regulation to scientific or technical progress, or (b) Annexes II and III to this Regulation as a result of the adoption by the Meeting of the Parties to the Protocol of any amendment to the Annexes to the Protocol, shall be adopted in accordance with the procedure referred to in Article 19(2). Article 19 Committee Procedure 1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months. Article 20 Penalties 1. Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. 2. The Member States shall notify those provisions to the Commission one year after entry into force of this Regulation at the latest and shall notify it without delay of any subsequent amendment affecting them. Article 21 Amendments to Directives 91/689/EEC and 96/61/EC 1. Article 8(3) of Directive 91/689/EEC shall be deleted. 2. Article 15(3) of Directive 96/61/EC shall be deleted. Article 22 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 18 January 2006. For the European Parliament The President J. BORRELL FONTELLES For the Council The President H. WINKLER (1) Opinion of 6 April 2005 (not yet published in the Official Journal). (2) Opinion of the European Parliament of 6 July 2005 (not yet published in the Official Journal) and Decision of the Council of 2 December 2005. (3) OJ L 242, 10.9.2002, p. 1. (4) OJ L 192, 28.7.2000, p. 36. (5) OJ L 184, 17.7.1999, p. 23. (6) OJ L 377, 31.12.1991, p. 20. Directive as amended by Directive 94/31/EC (OJ L 168, 2.7.1994, p. 28). (7) OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). (8) OJ L 194, 25.7.1975, p. 39. Directive as last amended by Regulation (EC) No 1882/2003. (9) OJ L 135, 30.5.1991, p. 40. Directive as last amended by Regulation (EC) No 1882/2003. (10) OJ L 41, 14.2.2003, p. 26. (11) OJ L 145, 31.5.2001, p. 43. ANNEX I Activities No Activity Capacity threshold 1. Energy sector (a) Mineral oil and gas refineries * (1) (b) Installations for gasification and liquefaction * (c) Thermal power stations and other combustion installations With a heat input of 50 megawatts (MW) (d) Coke ovens * (e) Coal rolling mills With a capacity of 1 tonne per hour (f) Installations for the manufacture of coal products and solid smokeless fuel * 2. Production and processing of metals (a) Metal ore (including sulphide ore) roasting or sintering installations * (b) Installations for the production of pig iron or steel (primary or secondary melting) including continuous casting With a capacity of 2,5 tonnes per hour (c) Installations for the processing of ferrous metals: (i) Hot-rolling mills With a capacity of 20 tonnes of crude steel per hour (ii) Smitheries with hammers With an energy of 50 kilojoules per hammer, where the calorific power used exceeds 20 MW (iii) Application of protective fused metal coats With an input of 2 tonnes of crude steel per hour (d) Ferrous metal foundries With a production capacity of 20 tonnes per day (e) Installations: (i) For the production of non-ferrous crude metals from ore, concentrates or secondary raw materials by metallurgical, chemical or electrolytic processes * (ii) For the smelting, including the alloying, of non-ferrous metals, including recovered products (refining, foundry casting, etc.) With a melting capacity of 4 tonnes per day for lead and cadmium or 20 tonnes per day for all other metals (f) Installations for surface treatment of metals and plastic materials using an electrolytic or chemical process Where the volume of the treatment vats equals 30 m3 3. Mineral industry (a) Underground mining and related operations * (b) Opencast mining and quarrying Where the surface of the area effectively under extractive operation equals 25 hectares (c) Installations for the production of: (i) Cement clinker in rotary kilns With a production capacity of 500 tonnes per day (ii) Lime in rotary kilns With a production capacity of 50 tonnes per day (iii) Cement clinker or lime in other furnaces With a production capacity of 50 tonnes per day (d) Installations for the production of asbestos and the manufacture of asbestos-based products * (e) Installations for the manufacture of glass, including glass fibre With a melting capacity of 20 tonnes per day (f) Installations for melting mineral substances, including the production of mineral fibres With a melting capacity of 20 tonnes per day (g) Installations for the manufacture of ceramic products by firing, in particular roofing tiles, bricks, refractory bricks, tiles, stoneware or porcelain With a production capacity of 75 tonnes per day, or with a kiln capacity of 4 m3 and with a setting density per kiln of 300 kg/m3 4. Chemical industry (a) Chemical installations for the production on an industrial scale of basic organic chemicals, such as: (i) Simple hydrocarbons (linear or cyclic, saturated or unsaturated, aliphatic or aromatic) (ii) Oxygen-containing hydrocarbons such as alcohols, aldehydes, ketones, carboxylic acids, esters, acetates, ethers, peroxides, epoxy resins (iii) Sulphurous hydrocarbons (iv) Nitrogenous hydrocarbons such as amines, amides, nitrous compounds, nitro compounds or nitrate compounds, nitriles, cyanates, isocyanates (v) Phosphorus-containing hydrocarbons (vi) Halogenic hydrocarbons (vii) Organometallic compounds (viii) Basic plastic materials (polymers, synthetic fibres and cellulose-based fibres) (ix) Synthetic rubbers (x) Dyes and pigments (xi) Surface-active agents and surfactants * (b) Chemical installations for the production on an industrial scale of basic inorganic chemicals, such as: (i) Gases, such as ammonia, chlorine or hydrogen chloride, fluorine or hydrogen fluoride, carbon oxides, sulphur compounds, nitrogen oxides, hydrogen, sulphur dioxide, carbonyl chloride (ii) Acids, such as chromic acid, hydrofluoric acid, phosphoric acid, nitric acid, hydrochloric acid, sulphuric acid, oleum, sulphurous acids (iii) Bases, such as ammonium hydroxide, potassium hydroxide, sodium hydroxide (iv) Salts, such as ammonium chloride, potassium chlorate, potassium carbonate, sodium carbonate, perborate, silver nitrate (v) Non-metals, metal oxides or other inorganic compounds such as calcium carbide, silicon, silicon carbide * (c) Chemical installations for the production on an industrial scale of phosphorous-, nitrogen- or potassium-based fertilisers (simple or compound fertilisers) * (d) Chemical installations for the production on an industrial scale of basic plant health products and of biocides * (e) Installations using a chemical or biological process for the production on an industrial scale of basic pharmaceutical products * (f) Installations for the production on an industrial scale of explosives and pyrotechnic products * 5. Waste and wastewater management (a) Installations for the recovery or disposal of hazardous waste Receiving 10 tonnes per day (b) Installations for the incineration of non-hazardous waste in the scope of Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste (2) With a capacity of 3 tonnes per hour (c) Installations for the disposal of non-hazardous waste With a capacity of 50 tonnes per day (d) Landfills (excluding landfills of inert waste and landfills, which were definitely closed before 16.7.2001 or for which the after-care phase required by the competent authorities according to Article 13 of Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (3) has expired) Receiving 10 tonnes per day or with a total capacity of 25 000 tonnes (e) Installations for the disposal or recycling of animal carcasses and animal waste With a treatment capacity of 10 tonnes per day (f) Urban waste-water treatment plants With a capacity of 100 000 population equivalents (g) Independently operated industrial waste-water treatment plants which serve one or more activities of this annex With a capacity of 10 000 m3 per day (4) 6. Paper and wood production and processing (a) Industrial plants for the production of pulp from timber or similar fibrous materials * (b) Industrial plants for the production of paper and board and other primary wood products (such as chipboard, fibreboard and plywood) With a production capacity of 20 tonnes per day (c) Industrial plants for the preservation of wood and wood products with chemicals With a production capacity of 50 m3 per day 7. Intensive livestock production and aquaculture (a) Installations for the intensive rearing of poultry or pigs (i) With 40 000 places for poultry (ii) With 2 000 places for production pigs (over 30 kg) (iii) With 750 places for sows (b) Intensive aquaculture With a production capacity of 1 000 tonnes of fish or shellfish per year 8. Animal and vegetable products from the food and beverage sector (a) Slaughterhouses With a carcass production capacity of 50 tonnes per day (b) Treatment and processing intended for the production of food and beverage products from: (i) Animal raw materials (other than milk) With a finished product production capacity of 75 tonnes per day (ii) Vegetable raw materials With a finished product production capacity of 300 tonnes per day (average value on a quarterly basis) (c) Treatment and processing of milk With a capacity to receive 200 tonnes of milk per day (average value on an annual basis) 9. Other activities (a) Plants for the pre-treatment (operations such as washing, bleaching, mercerisation) or dyeing of fibres or textiles With a treatment capacity of 10 tonnes per day (b) Plants for the tanning of hides and skins With a treatment capacity of 12 tonnes of finished product per day (c) Installations for the surface treatment of substances, objects or products using organic solvents, in particular for dressing, printing, coating, degreasing, waterproofing, sizing, painting, cleaning or impregnating With a consumption capacity of 150 kg per hour or 200 tonnes per year (d) Installations for the production of carbon (hard-burnt coal) or electro-graphite by means of incineration or graphitisation * (e) Installations for the building of, and painting or removal of paint from ships With a capacity for ships 100 m long (1) An asterisk (*) indicates that no capacity threshold is applicable (all facilities are subject to reporting). (2) OJ L 332, 28.12.2000, p. 91. (3) OJ L 182, 16.7.1999, p. 1. Directive as amended by Regulation (EC) No 1882/2003. (4) The capacity threshold shall be reviewed by 2010 at the latest in the light of the results of the first reporting cycle. ANNEX II Pollutants (1) No CAS number Pollutant (2) Threshold for releases (column 1) to air (column 1a) kg/year to water (column 1b) kg/year to land (column 1c) kg/year 1 74-82-8 Methane (CH4) 100 000 — (3) — 2 630-08-0 Carbon monoxide (CO) 500 000 — — 3 124-38-9 Carbon dioxide (CO2) 100 million — — 4 Hydro-fluorocarbons (HFCs) (4) 100 — — 5 10024-97-2 Nitrous oxide (N2O) 10 000 — — 6 7664-41-7 Ammonia (NH3) 10 000 — — 7 Non-methane volatile organic compounds (NMVOC) 100 000 — — 8 Nitrogen oxides (NOx/NO2) 100 000 — — 9 Perfluorocarbons (PFCs) (5) 100 — — 10 2551-62-4 Sulphur hexafluoride (SF6) 50 — — 11 Sulphur oxides (SOx/SO2) 150 000 — — 12 Total nitrogen — 50 000 50 000 13 Total phosphorus — 5 000 5 000 14 Hydrochlorofluorocarbons (HCFCs) (6) 1 — — 15 Chlorofluorocarbons (CFCs) (7) 1 — — 16 Halons (8) 1 — — 17 Arsenic and compounds (as As) (9) 20 5 5 18 Cadmium and compounds (as Cd) (9) 10 5 5 19 Chromium and compounds (as Cr) (9) 100 50 50 20 Copper and compounds (as Cu) (9) 100 50 50 21 Mercury and compounds (as Hg) (9) 10 1 1 22 Nickel and compounds (as Ni) (9) 50 20 20 23 Lead and compounds (as Pb) (9) 200 20 20 24 Zinc and compounds (as Zn) (9) 200 100 100 25 15972-60-8 Alachlor — 1 1 26 309-00-2 Aldrin 1 1 1 27 1912-24-9 Atrazine — 1 1 28 57-74-9 Chlordane 1 1 1 29 143-50-0 Chlordecone 1 1 1 30 470-90-6 Chlorfenvinphos — 1 1 31 85535-84-8 Chloro-alkanes, C10-C13 — 1 1 32 2921-88-2 Chlorpyrifos — 1 1 33 50-29-3 DDT 1 1 1 34 107-06-2 1,2-dichloroethane (EDC) 1 000 10 10 35 75-09-2 Dichloromethane (DCM) 1 000 10 10 36 60-57-1 Dieldrin 1 1 1 37 330-54-1 Diuron — 1 1 38 115-29-7 Endosulphan — 1 1 39 72-20-8 Endrin 1 1 1 40 Halogenated organic compounds (as AOX) (10) — 1 000 1 000 41 76-44-8 Heptachlor 1 1 1 42 118-74-1 Hexachlorobenzene (HCB) 10 1 1 43 87-68-3 Hexachlorobutadiene (HCBD) — 1 1 44 608-73-1 1,2,3,4,5,6-hexachlorocyclohexane(HCH) 10 1 1 45 58-89-9 Lindane 1 1 1 46 2385-85-5 Mirex 1 1 1 47 PCDD + PCDF (dioxins + furans) (as Teq) (11) 0,0001 0,0001 0,0001 48 608-93-5 Pentachlorobenzene 1 1 1 49 87-86-5 Pentachlorophenol (PCP) 10 1 1 50 1336-36-3 Polychlorinated biphenyls (PCBs) 0,1 0,1 0,1 51 122-34-9 Simazine — 1 1 52 127-18-4 Tetrachloroethylene (PER) 2 000 10 — 53 56-23-5 Tetrachloromethane (TCM) 100 1 — 54 12002-48-1 Trichlorobenzenes (TCBs) (all isomers) 10 1 — 55 71-55-6 1,1,1-trichloroethane 100 — — 56 79-34-5 1,1,2,2-tetrachloroethane 50 — — 57 79-01-6 Trichloroethylene 2 000 10 — 58 67-66-3 Trichloromethane 500 10 — 59 8001-35-2 Toxaphene 1 1 1 60 75-01-4 Vinyl chloride 1 000 10 10 61 120-12-7 Anthracene 50 1 1 62 71-43-2 Benzene 1 000 200 (as BTEX) (12) 200 (as BTEX) (12) 63 Brominated diphenylethers (PBDE) (13) — 1 1 64 Nonylphenol and Nonylphenol ethoxylates (NP/NPEs) — 1 1 65 100-41-4 Ethyl benzene — 200 (as BTEX) (12) 200 (as BTEX) (12) 66 75-21-8 Ethylene oxide 1 000 10 10 67 34123-59-6 Isoproturon — 1 1 68 91-20-3 Naphthalene 100 10 10 69 Organotin compounds(as total Sn) — 50 50 70 117-81-7 Di-(2-ethyl hexyl) phthalate (DEHP) 10 1 1 71 108-95-2 Phenols (as total C) (14) — 20 20 72 Polycyclic aromatic hydrocarbons (PAHs) (15) 50 5 5 73 108-88-3 Toluene — 200 (as BTEX) (12) 200 (as BTEX) (12) 74 Tributyltin and compounds (16) — 1 1 75 Triphenyltin and compounds (17) — 1 1 76 Total organic carbon (TOC) (as total C or COD/3) — 50 000 — 77 1582-09-8 Trifluralin — 1 1 78 1330-20-7 Xylenes (18) — 200 (as BTEX) (12) 200 (as BTEX) (12) 79 Chlorides (as total Cl) — 2 million 2 million 80 Chlorine and inorganic compounds (as HCl) 10 000 — — 81 1332-21-4 Asbestos 1 1 1 82 Cyanides (as total CN) — 50 50 83 Fluorides (as total F) — 2 000 2 000 84 Fluorine and inorganic compounds (as HF) 5 000 — — 85 74-90-8 Hydrogen cyanide (HCN) 200 — — 86 Particulate matter (PM10) 50 000 — — 87 1806-26-4 Octylphenols and Octylphenol ethoxylates — 1 — 88 206-44-0 Fluoranthene — 1 — 89 465-73-6 Isodrin — 1 — 90 36355-1-8 Hexabromobiphenyl 0,1 0,1 0,1 91 191-24-2 Benzo(g,h,i)perylene 1 (1) Releases of pollutants falling into several categories of pollutants shall be reported for each of these categories. (2) Unless otherwise specified any pollutant specified in Annex II shall be reported as the total mass of that pollutant or, where the pollutant is a group of substances, as the total mass of the group. (3) A hyphen (—) indicates that the parameter and medium in question do not trigger a reporting requirement. (4) Total mass of hydrogen fluorocarbons: sum of HFC23, HFC32, HFC41, HFC4310mee, HFC125, HFC134, HFC134a, HFC152a, HFC143, HFC143a, HFC227ea, HFC236fa, HFC245ca, HFC365mfc. (5) Total mass of perfluorocarbons: sum of CF4, C2F6, C3F8, C4F10, c-C4F8, C5F12, C6F14. (6) Total mass of substances including their isomers listed in Group VIII of Annex I to Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer (OJ L 244, 29.9.2000, p. 1). Regulation as amended by Regulation (EC) No 1804/2003 (OJ L 265, 16.10.2003, p. 1). (7) Total mass of substances including their isomers listed in Group I and II of Annex I to Regulation (EC) No 2037/2000. (8) Total mass of substances including their isomers listed in Group III and VI of Annex I to Regulation (EC) No 2037/2000. (9) All metals shall be reported as the total mass of the element in all chemical forms present in the release. (10) Halogenated organic compounds which can be adsorbed to activated carbon expressed as chloride. (11) Expressed as I-TEQ. (12) Single pollutants are to be reported if the threshold for BTEX (the sum parameter of benzene, toluene, ethyl benzene, xylenes) is exceeded. (13) Total mass of the following brominated diphenylethers: penta-BDE, octa-BDE and deca-BDE. (14) Total mass of phenol and simple substituted phenols expressed as total carbon. (15) Polycyclic aromatic hydrocarbons (PAHs) are to be measured for reporting of releases to air as benzo(a)pyrene (50-32-8), benzo(b)fluoranthene (205-99-2), benzo(k)fluoranthene (207-08-9), indeno(1,2,3-cd)pyrene (193-39-5) (derived from Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants (OJ L 229, 29.6.2004, p. 5)). (16) Total mass of tributyltin compounds, expressed as mass of tributyltin. (17) Total mass of triphenyltin compounds, expressed as mass of triphenyltin. (18) Total mass of xylene (ortho-xylene, meta-xylene, para-xylene). ANNEX III Format for the reporting of release and transfer data by Member States to the Commission Reference year Identification of the facility Name of the parent company Name of the facility Identification number of facility Street address Town/village Postal code Country Coordinates of the location River basin district (1) NACE-code (4 digits) Main economic activity Production volume (optional) Number of installations (optional) Number of operating hours in year (optional) Number of employees (optional) Text field for textual information or website address delivered by facility or parent company (optional) All Annex I activities of the facility (according to the coding system given in Annex I and the IPPC code where available) Activity 1 (main Annex I activity) Activity 2 Activity N Release data to air for the facility for each pollutant exceeding threshold value (according to Annex II) Releases to air Pollutant 1 Pollutant 2 Pollutant N M: measured; Analytical Method used C: calculated; Calculation Method used E: estimated T: Total in kg/year A: accidental in kg/year Release data to water for the facility for each pollutant exceeding threshold value (according to Annex II) Releases to water Pollutant 1 Pollutant 2 Pollutant N M: measured; Analytical Method used C: calculated; Calculation Method used E: estimated T: Total in kg/year A: accidental in kg/year Release data to land for the facility for each pollutant exceeding threshold value (according to Annex II) Releases to land Pollutant 1 Pollutant 2 Pollutant N M: measured; Analytical Method used C: calculated; Calculation Method used E: estimated T: Total in kg/year A: accidental in kg/year Off-site transfer of each pollutant destined for waste-water treatment in quantities exceeding threshold value (according to Annex II) Pollutant 1 Pollutant 2 Pollutant N M: measured; Analytical Method used C: calculated; Calculation Method used E: estimated in kg/year Off-site transfers of hazardous waste for the facility exceeding threshold value (according to Article 5) Within the country: For Recovery (R) M: measured; Analytical Method used C: calculated; Calculation Method used E: estimated in tonnes/year Within the country: For Disposal (D) M: measured; Analytical Method used C: calculated; Calculation Method used E: estimated in tonnes/year To other countries: For Recovery (R) Name of the recoverer Address of the recoverer Address of actual recovery site receiving the transfer M: measured; Analytical Method used C: calculated; Calculation Method used E: estimated in tonnes/year To other countries: For Disposal (D) Name of the disposer Address of the disposer Address of actual disposal site receiving the transfer M: measured; Analytical Method used C: calculated; Calculation Method used E: estimated in tonnes/year Off-site transfer of non-hazardous waste for the facility exceeding threshold value (according to Article 5) For Recovery (R) M: measured; Analytical Method used C: calculated; Calculation Method used E: estimated in tonnes/year For Disposal (D) M: measured; Analytical Method used C: calculated; Calculation Method used E: estimated in tonnes/year Competent authority for requests of the public: Name Street address Town/village Telephone No Fax No E-mail address (1) According to Article 3(1) of Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).

Summary: European Pollutant Release and Transfer Register (E-PRTR) European Pollutant Release and Transfer Register (E-PRTR) SUMMARY OF: Regulation (EC) No 166/2006 on the establishment of a European Pollutant Release and Transfer Register WHAT IS THE AIM OF THE REGULATION? The regulation establishes the European Pollutant Release and Transfer Register (E-PRTR). This is a publicly accessible electronic database of key environmental data from industrial facilities in Europe. In 2019, Regulation (EC) No 166/2006 was amended by Regulation (EU) No 1010/2019 to align and streamline the reporting requirements in EU environmental legislation. Among other things, the amending regulation conferred powers on the European Commission to adopt implementing acts specifying the type, format and frequency of information to be reported under Regulation (EC) No 166/2006. Commission Implementing Decision (EU) 2019/1741 introduced changes specific to the E-PRTR further to Regulation (EU) No 1010/2019. KEY POINTS The E-PRTR is available to the public free of charge on the internet. The information it contains can be searched using various criteria (type of pollutant, geographical location, affected environment, source facility, etc.). Content of the E-PRTR The register contains information on releases of pollutants to air, water and land, as well as off-site transfers of pollutants present in waste-water and waste. The register covers 91 pollutants as listed in Annex II of Regulation (EC) No 166/2006, including greenhouse gases, heavy metals, pesticides, and chlorinated organic substances. Releases are required to be reported when they exceed a certain threshold and originate from one of the 65 activities listed in Annex I of Regulation (EC) No 166/2006. The majority of these activities are also regulated under Directive 2010/75/EU on industrial emissions (see summary) and comprise, in particular, the facilities covered by the following sectors: energy production,production and processing of metals,mineral industry,chemical industry,waste and wastewater management,paper and wood production and processing,intensive livestock production and aquaculture,animal and vegetable products from the food and beverage sector, andother activities e.g. producing textiles, leather tanning. Where available, the register also provides information on releases from diffuse sources of air and diffuse sources of water. How the E-PRTR works Amending Regulation (EU) 2019/1010 requires: operators of each industrial facility to send their competent national authority information on their pollutant releases and transfers every year. This information covers pollutants to air, water and land, as well as off-site transfers of pollutants present in waste-water and waste;EU countries at national level to collate and check this information;national authorities to send this information by electronic transfer to the Commission within 11 months of the end of the reporting year;the Commission, assisted by the European Environment Agency, to incorporate the information reported by the EU countries, Iceland, Liechtenstein, Norway, Serbia and Switzerland into the E-PRTR within 1 month. Implementing Decision (EU) 2019/1741: specifies the electronic format to be developed by EU countries for this reporting process, as well as the information to be supplied by EU countries; unless otherwise specified in the Annex to the decision, the information was to be first submitted for the reporting year 2019; information in Sections 1 to 4 of the Annex must reach the Commission, at the latest, by 30 September of the following reporting year; information in Sections 5 to 10 of the Annex must reach the Commission at the latest, by 30 November of the following reporting year; is to be reviewed by 31 December 2024 to assess the feasibility of progressing towards the objective of earlier public availability of E-PRTR data. These amendments reduce from 16 months to 12 months the incorporation of the information reported by EU countries into the European PRTR, thus allowing the public more rapid access to this information. Public participation The regulation is a key instrument in delivering the requirements of the Aarhus convention as it provides the public with the opportunity to be involved in environmental decision making. FROM WHEN DOES THE REGULATION APPLY? It has applied since 24 February 2006. BACKGROUND The E-PRTR was created following the adoption of the United Nations Economic Commission for Europe 2003 Kyiv Protocol on pollutant release and transfer registers, signed by the EU in May 2003. Decision 2006/61/EC concludes the protocol, on behalf of the European Community (now the EU). For more information, see: European Pollutant Release and Transfer Register (E-PRTR) (European Commission) Protocol on pollutant release and transfer registers (UNECE). MAIN DOCUMENT Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18 January 2006 concerning the establishment of a European Pollutant Release and Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC (OJ L 33, 4.2.2006, pp. 1-17) Successive amendments to Regulation (EC) No 166/2006 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Implementing Decision (EU) 2019/1741 of 23 September 2019 establishing the format and frequency of data to be made available by the Member States for the purposes of reporting under Regulation (EC) No 166/2006 of the European Parliament and of the Council concerning the establishment of a European Pollutant Release and Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC (OJ L 267, 21.10.2019, pp. 3-8) Regulation (EU) 2019/1010 of the European Parliament and of the Council of 5 June 2019 on the alignment of reporting obligations in the field of legislation related to the environment, and amending Regulations (EC) No 166/2006 and (EU) No 995/2010 of the European Parliament and of the Council, Directives 2002/49/EC, 2004/35/EC, 2007/2/EC, 2009/147/EC and 2010/63/EU of the European Parliament and of the Council, Council Regulations (EC) No 338/97 and (EC) No 2173/2005, and Council Directive 86/278/EEC (OJ L 170, 25.6.2019, pp. 115-127) Protocol on Pollutant Release and Transfer Registers (OJ L 32, 4.2.2006, pp. 56-79) Council Decision 2006/61/EC of 2 December 2005 on the conclusion, on behalf of the European Community, of the UN-ECE Protocol on Pollutant Release and Transfer Registers (OJ L 32, 4.2.2006, pp. 54-55) last update 08.05.2020


29.12.2006 EN Official Journal of the European Union L 384/75 COMMISSION REGULATION (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Regulation (EC) No 1935/2004 of the European Parliament and the Council of 27 October 2004 on materials and articles intended to come into contact with food (1), and in particular Article 5(1) thereof, Whereas: (1) Groups of materials and articles listed in Annex I to Regulation (EC) No 1935/2004 and combinations of those materials and articles or recycled materials and articles used in those materials and articles should be manufactured in compliance with general and detailed rules on good manufacturing practice (GMP). (2) Some sectors of industry have established GMP guidelines, while others have not. Consequently, it appears necessary to ensure uniformity among Member States as regards GMP for materials and articles intended to come into contact with food. (3) In order to ensure such conformity, it is appropriate to lay down certain obligations on business operators. (4) All business operators should operate an effective quality management of their manufacturing operations which should be adapted to their position in the supply chain. (5) The rules should apply to materials and articles intended to be brought into contact with food, or already in contact with food and were intended for this purpose, or those which can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use. (6) The rules on GMP should be applied proportionately to avoid undue burdens for small businesses. (7) Detailed rules should now be set for processes involving printing inks and should be established for other processes as necessary. For printing inks applied to the non-food contact side of a material or article GMP should in particular ensure that substances are not transferred into food by set-off or transfer through the substrate. (8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, HAS ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation lays down the rules on good manufacturing practice (GMP) for the groups of materials and articles intended to come into contact with food (hereafter referred to as materials and articles) listed in Annex I to Regulation (EC) No 1935/2004 and combinations of those materials and articles or recycled materials and articles used in those materials and articles. Article 2 Scope This Regulation shall apply to all sectors and to all stages of manufacture, processing and distribution of materials and articles, up to but excluding the production of starting substances. The detailed rules set out in the Annex shall apply to the relevant individually mentioned processes, as appropriate. Article 3 Definitions For the purpose of this Regulation, the following definitions shall apply: (a) ‘good manufacturing practice (GMP)’ means those aspects of quality assurance which ensure that materials and articles are consistently produced and controlled to ensure conformity with the rules applicable to them and with the quality standards appropriate to their intended use by not endangering human health or causing an unacceptable change in the composition of the food or causing a deterioration in the organoleptic characteristics thereof; (b) ‘quality assurance system’ means the total sum of the organised and documented arrangements made with the purpose of ensuring that materials and articles are of the quality required to ensure conformity with the rules applicable to them and the quality standards necessary for their intended use; (c) ‘quality control system’ means the systematic application of measures established within the quality assurance system that ensure compliance of starting materials and intermediate and finished materials and articles with the specification determined in the quality assurance system; (d) ‘non-food-contact side’ means the surface of the material or article that is not directly in contact with food; (e) ‘food-contact side’ means the surface of a material or article that is directly in contact with the food. Article 4 Conformity with good manufacturing practice The business operator shall ensure that manufacturing operations are carried out in accordance with: (a) the general rules on GMP as provided for in Article 5, 6, and 7, (b) the detailed rules on GMP as set out in the Annex. Article 5 Quality assurance system 1. The business operator shall establish, implement and ensure adherence to an effective and documented quality assurance system. That system shall: (a) take account of the adequacy of personnel, their knowledge and skills, and the organisation of the premises and equipment such as is necessary to ensure that finished materials and articles comply with the rules applicable to them; (b) be applied taking into account the size of the business run by the operator, so as not to be an excessive burden on the business. 2. Starting materials shall be selected and comply with pre-established specifications that shall ensure compliance of the material or article with the rules applicable to it. 3. The different operations shall be carried out in accordance with pre-established instructions and procedures. Article 6 Quality control system 1. The business operator shall establish and maintain an effective quality control system. 2. The quality control system shall include monitoring of the implementation and achievement of GMP and identify measures to correct any failure to achieve GMP. Such corrective measures shall be implemented without delay and made available to the competent authorities for inspections. Article 7 Documentation 1. The business operator shall establish and maintain appropriate documentation in paper or electronic format with respect to specifications, manufacturing formulae and processing which are relevant to compliance and safety of the finished material or article. 2. The business operator shall establish and maintain appropriate documentation in paper or electronic format with respect to records covering the various manufacturing operations performed which are relevant to compliance and safety of the finished material or article and with respect to the results of the quality control system. 3. The documentation shall be made available by the business operator to the competent authorities at their request. Article 8 Entry into force This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. It shall apply from 1 August 2008. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 22 December 2006. For the Commission Markos KYPRIANOU Member of the Commission (1) OJ L 338, 13.11.2004, p. 4. ANNEX Detailed rules on good manufacturing practice Processes involving the application of printing inks to the non-food contact side of a material or article 1. Printing inks applied to the non food-contact side of materials and articles shall be formulated and/or applied in such a manner that substances from the printed surface are not transferred to the food-contact side: (a) through the substrate or; (b) by set-off in the stack or the reel, in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) No 1935/2004. 2. Printed materials and articles shall be handled and stored in their finished and semi-finished states in such a manner that substances from the printed surface are not transferred to the food-contact side: (a) through the substrate or; (b) by set-off in the stack or reel, in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) No 1935/2004. 3. The printed surfaces shall not come into direct contact with food.

Summary: Materials and articles in contact with food — good manufacturing practice Materials and articles in contact with food — good manufacturing practice SUMMARY OF: Commission Regulation (EC) No 2023/2006 — good manufacturing practice for materials and articles intended to come into contact with food SUMMARY WHAT DOES THE REGULATION DO? It lays down rules on good manufacturing practice (GMP)* for materials and articles that come into contact with food. KEY POINTS The legislation applies to all sectors and all stages of manufacture, processing and distribution of materials and articles. Businesses must: conform with good manufacturing practice; establish, implement and apply an effective and documented quality assurance system*; establish and maintain an effective quality control system; establish and maintain appropriate records, either in paper or electronic form, on specifications, formulae and processing on the safety of the individual product and the various manufacturing operations. Good manufacturing practice covers objects such as containers, packaging, paper, cardboard, ink and adhesives which could come into contact with food. Quality assurance systems take account of: the staff’s knowledge and skills and the organisation of the premises and equipment; the size of the business to prevent them being an excessive burden. Quality control systems include: monitoring the implementation of good manufacturing practice; and identifying and correcting any measures that fall short of the required standards. An amendment (Regulation (EC) No 282/2008) sets out a specific quality assurance system for recycled plastic materials and articles that come into contact with food. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 August 2008. KEY TERMS * Good manufacturing practice: those aspects of quality assurance that ensure materials and articles conform to quality standards, do not endanger human health or cause an unacceptable change in the composition of the food. * Quality assurance system: organised and documented arrangements that ensure materials and articles meet the quality required. ACT Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food (OJ L 384, 29.12.2006, pp. 75-78) Subsequent amendments to Regulation (EC) No 2023/2006 have been incorporated into the basic text. This consolidated version is of documentary value only. last update 02.05.2016