10.9.2008 EN Official Journal of the European Union L 241/21 COMMISSION DECISION of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC (Text with EEA relevance) (2008/721/EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, and in particular Articles 152 and 153 thereof, Whereas: (1) Three Scientific Committees were established by Commission Decision 2004/210/EC (1), as amended by Commission Decision 2007/263/EC (2): the Scientific Committee on Consumer Products (SCCP), the Scientific Committee on Health and Environmental Risks (SCHER), the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). (2) Certain tasks of the SCHER have been transferred to the European Chemical Agency (ECHA) established by Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3), and therefore the fields of competence of that Committee should be revised. (3) The experience with the functioning of the three Scientific Committees shows the need to introduce modifications and improvements in the structure and working procedures of the Committees. (4) The terms of office of the members of three Scientific Committees established by Commission Decision 2004/210/EC was prolonged by Commission Decision 2007/708/EC (4) and come to an end on 31 December 2008. Members of those committees remain in office until they are replaced or their appointments are renewed. (5) Therefore, and for the sake of clarity, it is necessary to replace Decision 2004/210/EC with a new Decision. (6) Sound and timely scientific advice is an essential requirement for Commission proposals, decisions and policy relating to consumer safety, public health and the environment. A flexible advisory structure is necessary in that respect, in order to ensure easier access to highly qualified scientific expertise in a wide range of fields. (7) The scientific advice on matters relating to consumer safety, public health and the environment must be based on the principles of excellence, independence and impartiality, and transparency, as developed in the Commission Communication on ‘The collection and use of expertise by the Commission: principles and guidelines. Improving the knowledge for better policies’ (5), and it must be organised in conformity with best practice principles of risk assessment. (8) It is essential that the Scientific Committees make best use of scientific expertise in the EU and beyond as may be necessary for a specific question. To that aim a pool of Scientific Advisors should be established adequately covering the fields of competence of the Committees. (9) The reorganisation of the advisory structure must provide increased flexibility to allow it to advise the Commission on matters falling under established areas of competence as well as on emerging and newly identified health risks and matters not within the competence of other Community risk assessment bodies, and must be able to provide rapid advice when needed, ensure full transparency and a high level of consistency and collaboration with other Community bodies and relevant scientific organisations. (10) The need for independent scientific advice both in established and new areas of Community responsibilities falling within the competence of the Scientific Committees is likely to continue to increase. The scientific advice structure on risk assessment needs therefore to be reinforced, in its composition as well as by more effective working practices. (11) Various Community bodies have been established which have among their tasks the assessment of risks in various domains. It is necessary to ensure consistency and promote coordination between the Scientific Committees and such bodies. The Scientific Committees need to reinforce their effectiveness also by appropriate exchanges of information and expertise and through collaboration with other scientific bodies and organisation at national and international level. (12) The working practices of the Scientific Committees should be improved by including, in addition to the internal work, the organisation of scientific meetings and workshops and the establishment of networks. (13) While preserving full independence, it is important to ensure openness and transparency of the work of the Scientific Committees by establishing appropriate stakeholder dialogue procedures. (14) The openness and transparency sought in the implementation of this Decision should be ensured while fully respecting the requirements laid down in the Community legislation with regard to the protection of personal data and to the access of the public to documents, including the protection of commercial confidentiality, HAS DECIDED AS FOLLOWS: CHAPTER 1 GENERAL PROVISIONS Article 1 The advisory structure and its fields of competence 1. An advisory structure on scientific risk assessment in the areas of consumer safety, public health and the environment is hereby established. This structure includes: (a) the Scientific Committee on Consumer Safety (hereinafter SCCS); (b) the Scientific Committee on Health and Environmental Risks (hereinafter SCHER); (c) the Scientific Committee on Emerging and Newly Identified Health Risks (hereinafter SCENIHR); (d) a Pool of Scientific Advisors on Risk Assessment (hereinafter the Pool), which will support the activities of the Scientific Committees in accordance with the relevant provisions of this Decision. 2. The fields of competence of the advisory structure shall be as set out in Annex I, without prejudice to the competencies conferred by Community legislation to other Community bodies undertaking risk assessment, such as, in particular, the European Food Safety Authority, the European Medicines Agency, the European Chemical Agency and the European Centre for Disease Control. Article 2 Mission 1. The Commission shall request a scientific opinion from the Scientific Committees in the cases laid down by Community law. 2. The Commission may also request an opinion from the Committees on questions: (a) of particular relevance to consumer safety, public health and the environment; and (b) not falling within the mandate of other Community bodies. 3. The Commission may also request the Scientific Committees to provide rapid advice on the state of scientific knowledge concerning specific risks in case of urgent needs. 4. The Commission may invite a Scientific Committee to identify research needs and assess research results in relation to the subject areas covered by its fields of competence. 5. At the request of the Commission, or acting on their own initiative and in agreement with the Commission, the Scientific Committees may decide to set up thematic workshops in order to review data and scientific knowledge on particular risks or on broad risk assessment issues. At the request of the Commission, they shall produce reports, position papers or conclusions resulting from these workshops. These workshops may involve, in addition to members of the Committees, scientific advisors from the Pool and external experts, including experts from Community, national or international bodies carrying out similar tasks, as appropriate. These workshops shall be organised by the Secretariat of the Scientific Committees. The Secretariat shall define and ensure, where appropriate, the dissemination of the reports, position papers or conclusions resulting from the workshops. 6. The Commission may invite the Scientific Committees to be part of thematic networks with other Community bodies or scientific organisations, in order to monitor and contribute to the development of scientific knowledge on risks in the fields of competence defined in Annex I. 7. The Scientific Committees shall draw the Commission’s attention to a specific or emerging problem falling within their remit, which they consider may pose an actual or potential risk to consumer safety, public health or the environment, by adopting and addressing to the Commission memoranda or position statements. The Commission may decide to publish such memoranda and statements and shall determine the action to be taken including, if appropriate, a request for a scientific opinion on the matter. CHAPTER 2 CONSTITUTION OF THE SCIENTIFIC COMMITTEES AND OF THE POOL Article 3 Appointment of the members of the Scientific Committees 1. The SCCS, the SCHER and the SCENIHR shall each consist of a maximum of 17 members and may associate, at their own initiative, up to 5 scientific advisors from the Pool to contribute to the Committee work on specific issues or disciplines. 2. The members of the Scientific Committees shall be appointed by the Commission on the basis of their expertise and consistent with this a geographical distribution that reflects the diversity of scientific problems and approaches, notably in Europe. The Commission shall determine the number of members of each Committee in accordance with the requisite needs. The members of each Scientific Committee shall be experts in one or more of the fields of competence of that Committee and shall collectively cover the widest possible range of disciplines. 3. The Commission shall appoint the members of the Scientific Committees from a list of suitable candidates established following publication in the Official Journal of the European Union and on the Commission website of a call for expressions of interest. 4. No member of a Scientific Committee may be appointed to more than one of the Committees set out in Article 1(1). Article 4 Establishment of the Pool 1. The Pool shall consist of scientific advisors who are experts in one or more of the fields of competence defined in Annex I or on related subjects, covering collectively the widest possible range of disciplines. 2. The Commission shall appoint scientific advisors to the Pool from a list of suitable candidates established following publication in the Official Journal of the European Union and on the Commission website of a call for expressions of interest. 3. The number of scientific advisors in the Pool at any time shall be decided by the Commission based on its needs for scientific advice. Article 5 Terms of office 1. Members of the Scientific Committees shall be appointed for a term of three years, and may not serve for more than three consecutive terms in the same Committee. They shall remain in office until they are replaced or their appointments are renewed. In order to safeguard the continuity of the expertise, the Commission may, in exceptional circumstances, prolong the terms of office of the members of a Scientific Committee for a period not exceeding 18 months. Members who have just completed three consecutive terms of office in a Scientific Committee shall be eligible for membership of another Scientific Committee. 2. When a member does not comply with the participation criteria which shall be laid down in the rules of procedures referred to in Article 12, or wishes to resign, the Commission may terminate the member’s membership and appoint a replacement from the Pool. 3. Scientific advisors shall be appointed to the Pool for a period of five years and their appointment may be renewed. CHAPTER 3 FUNCTIONING OF THE ADVISORY STRUCTURE Article 6 Resort to the support of the Pool 1. Each Scientific Committee may decide to associate up to five scientific advisors from the Pool to the preparation of a scientific opinion. These associated members shall participate in the activities and deliberations concerning the subject considered with the same functions, responsibilities and rights as the members of the Committee concerned. 2. In addition, each Scientific Committee may decide to invite other scientific advisors from the Pool to the preparation of a scientific opinion. Those advisors shall participate in the activities concerning the subject considered, but their functions and responsibility are restricted to the preparation of the opinion. 3. Scientific advisors from the Pool may also be invited by the Scientific Committees to assist them in the provision of a rapid advice requested by the Commission in accordance with Article 2(3), or to participate in thematic workshops referred to in Article 2(5). 4. Scientific advisors from the Pool may be invited by the Commission to participate in scientific meetings or to provide the Commission services with ad hoc information on specific issues. Article 7 Working groups 1. The Scientific Committees may create specific working groups the task of which shall consist of preparing and drafting their scientific opinions. These working groups shall be established in particular when there is a need for external expertise on a particular subject. 2. In agreement with the Commission, the Scientific Committees may invite associated members, other scientific advisors from the Pool, specialised external experts, as well as experts from other Community bodies that they consider to have the relevant scientific knowledge and expertise, to contribute to their work. 3. The working groups shall be chaired by a member of the Scientific Committee that convenes them and shall report to it, and may appoint a Rapporteur from among their participants. For particularly complex questions of a multidisciplinary nature, more than one Rapporteur may be appointed. 4. When a question is common to more than one Scientific Committee, a joint working group including members from the Committees concerned, as well as associated members, scientific advisors from the Pool and external experts as necessary, shall be set up. Article 8 Participation of trainees In agreement with the Commission and in accordance with the rules of procedure referred to in Article 12, the Scientific Committees may admit trainees to attend their meetings, with a view to contribute to capacity building in the area of risk assessment. Article 9 Special requirements 1. The Commission may require the adoption of a scientific opinion from a Scientific Committee within a specified period. 2. The Commission may require the adoption of a joint opinion on questions which do not fall within the fields of competence of a single Scientific Committee or which need to be considered by more than one Committee. A joint opinion, following a request for an opinion from the Commission, may also be adopted by Scientific Committees at the initiative of the Inter-Committee Coordination Group referred to in Article 11. 3. The Commission may define in the request for a scientific opinion the consultations, hearings or collaboration with other scientific bodies it deems necessary for the preparation of this opinion. Consultations and hearings may also be decided by a Committee, in agreement with the Commission, if considered necessary for completing an opinion. 4. A Scientific Committee may require additional information from stakeholders for the completion of a scientific opinion. A Scientific Committee may give a deadline for submitting the required information to it. In such a case, the Scientific Committee may decide to suspend its work on the scientific opinion in question. If the required information has not been submitted within that deadline, the Committee may adopt its opinion on the basis of the available information. Article 10 Election of the Chairs and Vice-Chairs 1. Each Scientific Committee shall elect a Chair and two Vice-Chairs from among their members. The election shall take place by simple majority of the members of the Committee. The term of office of the Chair and Vice-Chair shall be three years, renewable. 2. The procedure for the election of the Chair and Vice-Chairs of the Scientific Committees shall be laid down in the rules of procedures referred to in Article 12. Article 11 Coordination of the Scientific Committees An Inter-Committee Coordination Group (ICCG) composed of the Chairs and Vice-Chairs of the Scientific Committees shall ensure the coordination of the three Scientific Committees in accordance with the rules of procedures referred to in Article 12. Article 12 Rules of procedures 1. On proposal by and in agreement with the Commission, the Scientific Committees shall adopt common rules of procedures. 2. The rules of procedures shall ensure that the Scientific Committees perform their tasks in compliance with the principles of excellence, independence and transparency, whilst having regard to legitimate requests for commercial confidentiality as well as to the risk assessment principles which may be established by the Commission in light of the experience and in view of its policy in this area. 3. The rules of procedures shall cover in particular the subjects listed in Annex II. Article 13 Voting rules 1. The Scientific Committees shall adopt their opinions, rapid advice, memoranda and/or position statements by a majority of the total number of members of the Committee concerned combined with the number of associated members. 2. Each Scientific Committee shall act by a majority of its members on all other issues. 3. Those members of a Committee who have resigned or whose membership has been terminated in accordance with Article 5(2) shall not be taken into account for the calculation of the majority for the implementation of paragraphs 1 and 2. Article 14 Diverging opinions, coordination and collaboration with other Community, national or international bodies 1. The Scientific Committees shall assist the Commission and contribute to identifying at an early stage: (a) needs and possibilities for coordination of work and collaboration; (b) potential or actual divergences in scientific opinions with other relevant Community, national or international bodies carrying out similar tasks, on general or specific risk assessment issues. They shall assist the Commission in avoiding, resolving or clarifying divergent opinions and in establishing and maintaining collaboration relationships with such bodies. 2. The Commission may take the initiative to request and organise joint work of the Scientific Committees with Community, national or international bodies carrying out similar tasks. It may in particular request the Scientific Committees to produce joint opinions with other Community bodies, upon agreement with such bodies. 3. Where a substantive divergence over scientific issues has been identified and the body in question is a Community body, the Scientific Committee concerned shall, on the request of the Commission, cooperate with the body concerned with a view to either resolving the divergence or presenting a joint document to the Commission clarifying the contentious scientific issues and identifying the relevant uncertainties in the data. This document shall be made public. CHAPTER 4 PRINCIPLES Article 15 Independence 1. The Members of the Scientific Committees, associated members, other scientific advisors of the Pool and the external experts shall be nominated in a personal capacity. They shall not delegate their responsibilities to any other person. 2. Members of the Scientific Committees and, scientific advisors of the Pool, and the external experts participating in working groups shall undertake to act independently of any external influence. For that purpose they shall make a declaration of commitment to act in the public interest and a declaration of interests indicating either the absence or existence of any direct or indirect interest which might be considered prejudicial to their independence. These declarations shall be made in writing. Members of the Scientific Committees and scientific advisors from the Pool shall make annual declarations. 3. Members of the Scientific Committees, associated members and other scientific advisors, and the external experts participating in working groups shall declare at each meeting any specific interest which might be considered as prejudicial to their independence in relation to the items on the agenda. Article 16 Transparency 1. The activities of the Scientific Committees shall be carried out with a high level of transparency. The Commission shall in particular make available to the public on its website, without undue delay: (a) the request for opinions addressed to the Scientific Committees; (b) agendas and minutes of the meetings of the Scientific Committees, Inter-Committee Coordination Group and working groups; (c) the scientific opinions, and rapid advice adopted by the Scientific Committees, including the minority opinions and the names of the participants in the working groups that contributed to the opinion concerned; minority opinions shall be attributed to the members or advisors concerned; (d) the common rules of procedures of the Scientific Committees; (e) the names of the members of the Scientific Committees as well as of the scientific advisors from the Pool, together with a brief curriculum vitae of each member and advisor; (f) the declarations of interests of the members of the Scientific Committees, of the scientific advisors from the Pool and of the external experts that participated in a working group. 2. The transparency rules referred to in paragraph 1 shall be applied in accordance with the requirements of Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (6) (EC), and 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 (7), especially with regard to commercial confidentiality. Article 17 Confidentiality The members of the Scientific Committees, scientific advisors, external experts and trainees shall not divulge information acquired as a result of the work of the Scientific Committees, thematic workshops, working groups or other activities related to the application of this Decision, when they are informed that it is confidential. CHAPTER 5 FINAL PROVISIONS Article 18 Secretariat of the Commission’s Scientific Committees 1. The Scientific Committees and their working groups, the ICCG as well as other meetings, workshops or events related to the application of this Decision shall be convened by the Commission. 2. The Commission shall provide the scientific and administrative secretariat for the Scientific Committees and their working groups as well as for all other activities related to the application of this Decision. 3. The secretariat shall be responsible for providing scientific and administrative support necessary to facilitate the efficient functioning of the Scientific Committees, to monitor compliance with the rules of procedure, particularly in relation to the requirements for excellence, independence and transparency, to ensure communication on the Committees’ activities and the appropriate stakeholder dialogue, including in particular organisation of hearings on the activities of the Committees, and publication of the opinions and other public documents. Moreover, the secretariat shall provide support to the Committees and organise and apply quality control of the opinions, as provided for in the rules of procedure, as far as completeness, consistency, clarity, correspondence with requests and with editorial standards are concerned. 4. The secretariat shall ensure the scientific and technical coordination of the activities of the Scientific Committees and where necessary coordination of their activities with those of other Community, national and international bodies, as well as the application of the stakeholder dialogue procedure set up in the rules of procedure and the communication on the activities of the Committees. Article 19 Reimbursements and indemnities Members of the Scientific Committees, scientific advisors from the Pool and external experts shall be entitled to an indemnity for their participation in the meetings of the Committees, thematic workshops, working groups and other meetings and events organised by the Commission, and for serving as Rapporteur on a specific question, as provided for in Annex III. Reimbursement of travel and subsistence costs shall be paid by the Commission. Article 20 Replacement of the Scientific Committees The Scientific Committees established by Article 1(1) of this Decision shall replace the existing Scientific Committees established by Decision 2004/210/EC as follows: (a) the Scientific Committee on Consumer Safety shall replace the Scientific Committee on Consumer Products; (b) the Scientific Committee on the Health and Environmental Risks shall replace the Committee of the same name; (c) the Scientific Committee on Emerging and Newly Identified Health Risks shall replace the Scientific Committee of the same name. Article 21 Repeals 1. Decision 2004/210/EC is repealed. However, the three Committees established by that decision shall remain in office until the Scientific Committees established by this Decision take office. 2. References to the repealed decision shall be understood as applicable to this Decision; references to the Committees established by the repealed decision shall be understood as applicable to the Committees established by this Decision. Done at Brussels, 5 August 2008. For the Commission Androulla VASSILIOU Member of the Commission (1) OJ L 66, 4.3.2004, p. 45. (2) OJ L 114, 1.5.2007, p. 14. (3) OJ L 396, 30.12.2006, p. 1. Corrected by OJ L 136, 29.5.2007, p. 3. (4) OJ L 287, 1.11.2007, p. 25. (5) COM(2002) 713 final of 11 December 2002. (6) OJ L 8, 12.1.2001, p. 1. (7) OJ L 145, 31.5.2001, p. 43. ANNEX I FIELD OF COMPETENCE 1. Scientific Committee on Consumer Safety It shall provide opinions on questions concerning all types of health and safety risks (notably chemical, biological, mechanical and other physical risks) of non-food consumer products (for example: cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products such as detergents, etc.) and services (for example: tattooing, artificial sun tanning, etc.). 2. Scientific Committee on Health and Environmental Risks It shall provide opinions on health and environmental risks related to pollutants in the environmental media and other biological and physical factors or changing physical conditions which may have a negative impact on health and the environment, for example in relation to air quality, waters, waste and soils, as well as on life cycle environmental assessment. It shall also address health and safety issues related to the toxicity and eco-toxicity of biocides. Without prejudice to the competences conferred on the European Chemical Agency (ECHA), Scientific Committee on Consumer Safety (SCCS) and other European risk assessment agencies, it may also be invited by the Commission to address, notably in collaboration with other European agencies and in particular ECHA, questions relating to examination of the toxicity and eco-toxicity of chemical, biochemical and biological compounds whose use may have harmful consequences for human health and the environment. In addition, the Committee will address questions relating to methodological aspect of the assessment of health and environmental risks of chemicals, including mixtures of chemicals, as necessary for providing sound and consistent advice in its own areas of competence as well as in order to contribute to the relevant issues in close cooperation with other European agencies. 3. The Scientific Committee on Emerging and Newly Identified Health Risks It shall provide opinions on questions concerning emerging or newly identified health and environmental risks and on broad, complex or multidisciplinary issues requiring a comprehensive assessment of risks to consumer safety or public health and related issues not covered by other Community risk assessment bodies. Examples of potential areas of activity include potential risks associated with interaction of risk factors, synergic effects, cumulative effects, antimicrobial resistance, new technologies such as nanotechnologies, medical devices including those incorporating substances of animal and/or human origin, tissue engineering, blood products, fertility reduction, cancer of endocrine organs, physical hazards such as noise and electromagnetic fields (from mobile phones, transmitters and electronically controlled home environments), and methodologies for assessing new risks. It may also be invited to address risks related to public health determinants and non-transmissible diseases. ANNEX II RULES OF PROCEDURES The common rules of procedures to be adopted by the Scientific Committees in accordance with Article 12 shall cover in particular the following subjects: 1. coordination between the Scientific Committees (a) the designation of the Scientific Committee responsible on request for scientific opinions which do not fall within the fields of competence of a single Scientific Committee or which need to be considered by more than one Committee; (b) the adoption of joint opinions, rapid advice, memoranda and/or position statements; (c) the procedures for ensuring coordination between the Scientific Committees including matters relating to harmonisation of risk assessment and the functioning of the Inter-Committee Coordination Group; 2. decision procedures within the Committees (a) the election of the Chair and Vice-Chairs of the Scientific Committees; (b) the procedures for the adoption of opinions: — under normal conditions, — under written procedure under normal conditions, and — under an accelerated, written procedure if the urgency of the matter requires such a procedure; (c) the procedure for the provision of rapid advice when so requested by the Commission in accordance with Article 2(3); this procedure shall ensure the quality and appropriate endorsement by the Committee of the advice; (d) the adoption of memoranda and position papers to draw the attention of the Commission to specific or emerging problems; 3. organisation of the scientific works (a) the creation and organisation of the working groups of the Scientific Committees, including joint working groups; (b) the association of scientific advisors from the Pool to the activities of the Committees and the involvement of external experts; (c) the appointment of Rapporteurs and the description of their tasks in relation to the preparation of draft opinions for the Scientific Committees; (d) the format and content of scientific opinions and procedures for ensuring and improving their coherence as well as the editing standards; (e) the organisation of, and participation in, meetings, thematic workshops, and networks; (f) the association of trainees; 4. obligations of the members of the Committee, the associated and other scientific advisors from the Pool, external experts and for the trainees (a) the participation criteria and the conditions under which membership of the Committee shall expire; (b) the implementation of the confidentiality requirements laid down in Article 17; (c) the responsibilities and obligations of members, associated and other scientific advisors from the Pool and external experts in relation to their contacts with petitioners, special interest groups and other stakeholders; (d) the conditions and the procedure under which a member of a Committee, an associated or other scientific advisor or an external expert should be excluded from the deliberations and/or the vote on a particular subject in the Committee or in a working group, where there are reasonable doubts on his independence; 5. relations with third parties (a) procedures for identifying, resolving or clarifying diverging opinions with Community, national and international bodies carrying out similar tasks, including information exchange and the organisation of joint meetings; (b) representation of a Scientific Committee in external activities, notably in relation to other Community or international bodies engaged in similar activities; (c) the organisation of the stakeholder dialogue procedure, in particular the organisation of hearings with industry or other special interest groups or other stakeholders; (d) the publication of scientific opinions and other documents. ANNEX III INDEMNITIES Members of the Scientific Committees, scientific advisors from the Pool and the external experts shall be entitled to indemnities related to their participation in the activities of the scientific committees as follows: for participation at meetings: — EUR 300 for each full day participation or EUR 150 for participation in a morning or afternoon meeting of a Scientific Committee, a working group or at an external meeting attended in connection with the work of a Scientific Committee; for acting as Rapporteur for a question requiring not less than one day of preparation of a draft opinion and with the prior written agreement of the Commission: — EUR 300, — where fully justified and subject to budget availability, this sum may be increased to EUR 600 for questions which are particularly demanding in terms of work load. The Commission will regularly assess the need to adapt these indemnities in light of prices indexes, the evaluation of indemnities paid to experts in other European bodies and the experience on the workload for members, associated members, other scientific advisors and external experts. The first assessment will take place in 2009.

Summary: Scientific Committees for consumer safety, public health and the environment Scientific Committees for consumer safety, public health and the environment The European Union is establishing three advisory Scientific Committees working in the fields of consumer safety, public health and the environment. Their job is to provide the Commission with scientific advice in their respective fields. ACT Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC [See Amending act(s)]. SUMMARY The current Decision sets up an advisory structure to assist the Commission in evaluating scientific risks related to consumer safety, public health and the environment. This structure is composed of three committees: the Scientific Committee on Consumer Products (SCCP), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). The committees are consulted on questions which do not fall within the competence of other Community bodies. They give opinions at the request of the Commission or on their own initiative, in particular in the case of an emergency concerning a specific risk or to identify new research needs. Fields of competence The SCCP provides opinions on all existing risks to the health and safety of consumers concerning non-food products, such as cosmetic products, toys, textiles, clothing, personal care products, household products (detergents, etc.) and consumer services (tattooing, etc.). The SCHER provides opinions on the health and environmental risks caused by pollution or changing physical conditions such as air, water and soil quality. It provides environmental assessments on the life cycle and toxicity and ecotoxicity of biocides. In collaboration with other competent European bodies, it can provide opinions on the toxicity and ecotoxicity of chemical, biochemical and biological compounds. The SCENIHR provides opinions on questions concerning emerging or newly identified health risks, as well as on broader issues or those related indirectly to risk assessment. Examples of potential areas of activity include antimicrobial resistance, new technologies (nanotechnologies, etc.), medical devices (including those incorporating substances of animal and/or human origin), tissue engineering, blood products, fertility reduction, cancer of endocrine organs, physical hazards such as noise and electromagnetic fields (from mobile phones, transmitters and electronically controlled home environments). It can also provide opinions on risks related to public health determinants and non-transmissible diseases. How the Committees work The members of the three Committees are appointed by the Commission on the basis of their skills and according to a geographical distribution. The SCCP, the SCHER and the SCENIHR comprise a maximum of 17 members each. The Commission decides the number of appointed members to each committee depending on the scientific requirements. Members have a renewable term of three years. They cannot be appointed to the same committee more than three times consecutively. The Commission appoints scientific advisors to the Pool for a period of five years, renewable. The committees can invite five experts as associate members to contribute to the preparation of opinions and deliberations. When required the scientific committees can use the assistance of working groups open to specialised external experts. The three Committees have adopted common rules of procedure which ensure their compliance with the principles of excellence, independence, transparency and confidentiality. The committees are coordinated by an Inter-Committee Coordination Group (ICCG) composed of the Chairs and Vice-Chairs of the scientific committees. Context Decision 2004/210/EC is repealed to improve the effectiveness of the advisory structure of scientific committees, to enlarge the scope of scientific expertise and to reduce the reaction time to risks. References Act Entry into force Deadline for transposition in the Member States Official Journal Decision 2008/721/EC 5.9.2008 - OJ L 241 of 10.9.2008 Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal Decision 2009/566/EC 27.7.2009 - OJ L 196 of 28.7.2009 Decision 2010/309/EU 5.6.2010 - OJ L 138 of 4.6.2010 Last updated: 20.08.2010


28.3.2008 EN Official Journal of the European Union L 86/9 COMMISSION REGULATION (EC) No 282/2008 of 27 March 2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006 (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 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 5(1) thereof, After consulting the European Food Safety Authority (‘the Authority’), Whereas: (1) Directive 94/62/EC of the European Parliament and of the Council of 20 December 1994 on packaging and packaging waste (2) promotes the recovery and incineration at waste incineration plants with energy recovery and recycling of packaging waste. (2) Regulation (EC) No 1935/2004 sets out the general principles for eliminating the differences between the laws of Member States as regards materials and articles in contact with food and provides in Article 5(1) for the adoption of specific measures for groups of materials and articles. That Regulation identifies that harmonisation of rules on recycled plastic materials and articles should be given priority. (3) Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (3) sets out rules for plastic materials and articles which are intended to come into contact with foodstuffs. (4) Plastic packaging waste may contain residues from previous use, contaminants from misuse and contaminants from non-authorised substances. Therefore it is necessary to lay down special requirements to ensure that materials and articles produced from recycled plastics and intended for food contact respect the requirements of Article 3 of Regulation (EC) No 1935/2004. (5) 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 (4) lays down rules on good manufacturing practice for groups of materials and articles intended to come into contact with food 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. (6) Plastic waste can be treated mechanically to produce recycled materials and articles or it can be broken down to monomers and oligomers by chemical depolymerisation. Monomers and oligomers resulting from chemical depolymerisation should not be treated differently from monomers manufactured by chemical synthesis. Therefore, they are covered by the authorisation of monomers and additives in Directive 2002/72/EC and they should comply with the specifications and purity criteria established therein. Therefore, they should not be covered by this Regulation. (7) Offcuts and scraps from the production of plastic food contact materials, that has not been in contact with food or otherwise contaminated and is re-melted on the premises into new products or sold to a third party as part of a quality control system in compliance with the rules for good manufacturing practice laid down in Regulation (EC) No 2023/2006 would be considered as suitable for food contact applications and should not fall under the scope of this Regulation. All other offcuts and scraps from the production of plastic food contact materials should fall within the scope of the present Regulation. (8) Recycled plastic used behind a plastic functional barrier as defined by Directive 2002/72/EC should not be covered by the authorisation procedure in this Regulation. The rules set out in Directive 2002/72/EC for substances used behind a plastic functional barrier are regarded as sufficient to ensure the safety also of recycled plastics used behind a functional barrier. (9) Directive 2002/72/EC lays down lists of substances authorised to be used in the manufacture of plastic food contact materials or articles. These substances have been evaluated for their safety and migration limits have been set for their safe use. To ensure the same level of safety of recycled plastic materials and articles only authorised monomers and additives should be added to the recycled plastics and their migration limits should also be respected by recycled plastic food contact materials. (10) Directive 2002/72/EC provides for a declaration of compliance and record keeping to ensure that relevant information on the safe use of the plastic material is passed on between business operators and to the competent authorities. Those general rules are also valid for recycled plastics; therefore, they should apply also to recycled plastic food contact materials and articles. (11) Only the combination of characteristic of the input, sorting efficiency, and the effectiveness of the process to reduce contamination together with the defined use of recycled plastic ensure the safety of the recycled plastic material and article. They are specific to the type of plastic and the recycling process applied. It is only feasible to evaluate all these aspects together in individual evaluations of the recycling processes followed by individual authorisations. (12) The safety of the recycled plastics can only be ensured if the recycling process is able to produce a reproducible quality of the recycled plastics. This can be controlled if an effective quality assurance system is applied. Therefore, only recycled plastics from a recycling process managed by an effective quality assurance system should be placed on the market. (13) Directive 2002/72/EC lays down the list of monomers and starting substance authorised to the exclusion of all others (positive list) to be used in the manufacture of plastic food contact materials or articles and, therefore, only materials and articles complying with the provisions laid down in Directive 2002/72/EC should be used as input for the recycling process. This can be achieved by sorting the plastic articles before recycling. For certain materials, such as polyolefines, due to their physico-chemical properties, 100 % sorting efficiency may be necessary to ensure recycled plastic that complies with the requirements of Article 3 of Regulation (EC) No 1935/2004. This sorting efficiency can be achieved in product loops which are in a closed and controlled chain. For other materials, for example, PET the safety of the recycled plastic can be ensured with a lower sorting efficiency as regards to its former use in food contact which is realistically achievable from kerbside collection systems. The sorting efficiency necessary for each material should be identified on a case by case basis. (14) Plastic waste may be contaminated by substances from the previous use or incidental misuse of the plastics or by substances originating from non-food contact grade plastic. As it is not possible to know all possible types of contamination and as different types of plastics have different capacities to retain and release contaminants it is not possible to set defined characteristics for the final product applicable to all types of recycled plastics. Therefore a combination of input characterisation together with an adequate process to remove possible contamination is necessary to control the safety of the final product. (15) In the mechanical treatment, in which the plastic waste is ground into small pieces and cleaned, special care has to be taken to remove these contaminations. The recycling process must demonstrate that it can efficiently reduce potential contamination to a level that does not pose a risk to human health. The contaminants should only migrate in levels comparable to or well below levels demonstrated in the challenge tests of that recycling process or in other appropriate analytical test and should comply with the requirements of Article 3 of Regulation (EC) No 1935/2004. A safety assessment should verify that the recycling process fulfils these conditions. Alternatively, for non-fillable materials and articles, such as crates and pallets that are handled in product loops in a closed and controlled chain in which all steps of manufacture, distribution and use are controlled, it may be sufficient to prove that contamination can be excluded when they are only used in contact with dry food such as fruits and vegetables. (16) Certain types of plastic materials and articles manufactured with recycled plastics may only be suitable for contact with specified types of food under certain conditions. A safety assessment should identify these materials and articles and appropriate contact conditions. (17) Differences between national laws, regulations and administrative provisions concerning the safety assessment and the authorisation of recycling processes, used in the manufacture of materials and articles intended to come into contact with food, may hinder the free movement of these materials and articles, creating conditions of unequal and unfair competition. An authorisation procedure should therefore be established at Community level on the basis of the authorisation procedure provided for in Articles 9 to 12 of Regulation (EC) No 1935/2004. (18) The authorisation procedure provided for in Article 9 to 12 of Regulation (EC) No 1935/2004 is intended for the authorisation of substances. Changes to that procedure should be introduced in the present Regulation to adapt the authorisation procedure to the authorisation of recycling processes. These changes are specific procedural rules as referred to in Article 5(1)(n) of Regulation (EC) No 1935/2004. (19) A safety assessment of the recycling process should be carried out by the European Food Safety Authority (‘the Authority’). In order to inform the applicant of the data to be provided for the safety assessment, the Authority should publish detailed guidance concerning the preparation and the submission of the application. (20) The safety assessment of the recycling process should be followed by a risk management decision as to whether this recycling process should be authorised. That decision should be adopted in accordance with the regulatory procedure described in Article 23(2) of Regulation (EC) No 1935/2004 so as to ensure close cooperation between the Commission and the Member States. (21) The recycling process is company specific as regards technology and process parameters used. Therefore, only process specific authorisations should be granted. The authorisation procedure provided for in Articles 9 to 12 of Regulation (EC) No 1935/2004 should be adapted accordingly. (22) It should be possible to apply the process in different production sites as long as technology and process parameters as described in the application and authorisation are adhered to. (23) The public should be informed on the authorised recycling processes. For that purpose, a Community register, as referred to in Article 5(1)(m) of Regulation (EC) No 1935/2004, of recycling processes authorised under this Regulation should be established including the description of the field of application for the recycled plastic of the authorised process. (24) The recycling and the converting plant should be subject to inspection and control by the Member State. Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure verification of compliance with feed and food law, animal health and animal welfare rules (5) also covers official control on food contact materials. The most efficient way to control if the recycling process is applied as specified in the authorisation and to control if an effective quality assurance system is in place is the auditing of the recycling plant by the competent authorities. Therefore official controls performed to ensure compliance with this Regulation should include audits as specified in Article 10 of Regulation (EC) No 882/2004. The audits should be made in the most cost effective manner possible to keep to a minimum the administrative and economic burden to competent authorities and small and medium enterprises. (25) To ensure an efficient control Member States and the Commission should be informed about the recycling or manufacturing sites in which the authorised recycling process is being applied. (26) Industry should be enabled to label that their packaging contains recycled plastics. However, consumers should not be misled by labelling as regards recycled content. Rules for labelling of recycled plastics in relation to the content of recycled plastics have been laid down in EN ISO 14021. To ensure adequate information of the consumer when recycled plastics are labelled, they should follow transparent rules as those laid down in EN ISO 14021 or equivalent. (27) Article 16 of Regulation (EC) No 1935/2004 requires a declaration of compliance for materials and articles. The converter of recycled plastic material and articles should declare that he is using only recycled plastic from an authorised process and that the final product respects Community and national provisions applicable to it, in particular Regulation (EC) No 1935/2004 and Directive 2002/72/EC. The recycler should provide the converter with the information that the recycled plastic is produced by an authorised process and specify its field of application. Therefore, both the finished recycled plastic materials and articles and the recycled plastic should be accompanied by a declaration of compliance. General information to be provided in the declaration is already laid down in Directive 2002/72/EC. Therefore, this Regulation should only specify the additional information in relation to the content of recycled plastics in the recycled plastic materials and articles. (28) Since recycled materials and articles are already on the market in the Member States, provision should be made to ensure that the transition to a Community authorisation procedure is smooth and does not disturb the existing recycled plastic materials and articles market. Sufficient time should be allowed for applicants to make available to the Authority the information necessary for the safety assessment of the recycled plastic used in such products. Therefore, a certain time period, (the ‘initial authorisation phase’), should be fixed during which time the information for existing recycling processes should be submitted by the applicants to the Authority. Applications for authorisations of new recycling processes may also be submitted during the initial authorisation phase. The Authority should evaluate without delay all applications for existing, as well as new recycling processes for which sufficient information has been submitted during the initial authorisation phase. (29) Specific requirements need to be set on the quality assurance system applied in recycling processes. As the quality assurance is part of the good manufacturing practice which is covered by Regulation (EC) No 2023/2006 the specific requirements on the quality assurance system should be included in the Annex to that Regulation. (30) 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 and scope 1. This Regulation shall apply to the plastic materials and articles and parts thereof intended to come into contact with foodstuffs as referred to in Article 1 of Directive 2002/72/EC which contain recycled plastic (hereafter ‘recycled plastic materials and articles’). 2. This Regulation shall not apply to the following recycled plastic materials and articles, provided that they have been manufactured according to good manufacturing practice, as laid down in Regulation (EC) No 2023/2006: (a) recycled plastic materials and articles made with monomers and starting substances, derived from chemical depolymerization of plastic materials and articles; (b) recycled plastic materials and articles made from unused plastic production offcuts and/or process scraps in compliance with Directive 2002/72/EC, that are recycled within the manufacturing site or are used at another site; (c) recycled plastic materials and articles in which the recycled plastic is used behind a plastic functional barrier, as specified in Directive 2002/72/EC. 3. The plastic materials and articles that fall within the scope of this Regulation remain subject to Directive 2002/72/EC. Article 2 Definitions 1. For the purposes of this Regulation, the definitions laid down in Regulation (EC) No 1935/2004 and Directive 2002/72/EC shall apply. 2. The following definitions shall also apply: (a) ‘recycling process’ means a process in which plastic waste is recycled pursuant to the definition of recycling in point 7 of Article 3 of Directive 94/62/EC on packaging and packaging waste; for the purpose of this Regulation, this term is limited to processes, in which a recycled plastic is produced; (b) ‘plastic input’ means collected and sorted post-use plastic materials and articles used as input into a recycling process; (c) ‘product loops which are in a closed and controlled chain’ means manufacture and distribution cycles in which products circulate with a controlled reuse and distribution system, and in which the recycled material originates only from these entities in the chain, so that the unintentional introduction of external material is just the minimum technically feasible; (d) ‘challenge test’ means a demonstration of the effectiveness of a recycling process to remove chemical contamination from plastic materials or articles; (e) ‘converter’ means the natural or legal person responsible for ensuring that the requirements of this Regulation, as regards the recycled plastic materials and articles are met within the business under their control; (f) ‘recycler’ means the natural or legal person responsible for ensuring that the requirements of this Regulation, as regards the recycling process are met within the business under their control. Article 3 Requirements for recycled plastic materials and articles 1. Recycled plastic materials and articles shall only be placed on the market if they contain recycled plastic obtained only from a recycling process, authorised in accordance with this Regulation. 2. The authorised recycling process, referred to in paragraph 1 of this Article, shall be managed by an appropriate quality assurance system that ensures that the recycled plastic complies with the requirements set out in the authorisation. That quality assurance system shall comply with the detailed rules laid down in the Annex to Regulation (EC) No 2023/2006. Article 4 Conditions for the authorisation of recycling processes In order to be authorised, a recycling process shall comply with the following conditions: (a) the quality of plastic input must be characterised and controlled in accordance with pre-established criteria that ensure compliance of the final recycled plastic material and article with Article 3 of Regulation (EC) No 1935/2004; (b) the plastic input must originate from plastic materials and articles that have been manufactured in accordance with Community legislation on plastic food contact materials and articles, in particular Council Directive 78/142/EEC of 30 January 1978 on the approximation of laws of the Member States relating to materials and articles which contain vinyl chloride monomer and are intended to come into contact with foodstuffs (6) and Directive 2002/72/EC; (c) (i) either the plastic input must originate from a product loop which is in a closed and controlled chain ensuring that only materials and articles which have been intended for food contact are used and any contamination can be ruled out; or (ii) it must be demonstrated in a challenge test, or by other appropriate scientific evidence that the process is able to reduce any contamination of the plastic input to a concentration that does not pose a risk to human health; (d) the quality of the recycled plastic must be characterised and controlled in accordance with pre-established criteria that ensure compliance of the final recycled plastic material and article with Article 3 of Regulation (EC) No 1935/2004; (e) there must be established conditions of use of the recycled plastic whereby it can be ensured that the recycled plastic materials and articles comply with Article 3 of Regulation (EC) No 1935/2004. Article 5 Application for authorisation of recycling processes and opinion of the Authority 1. The procedure for authorisation laid down in Articles 9 and 10 of Regulation No (EC) 1935/2004 shall apply mutatis mutandis for the authorisation of recycling processes, subject to the specific provisions laid down in paragraphs 2 to 4 of this Article. 2. The technical dossier shall contain the information specified in the guidelines for the safety assessment of a recycling process to be published by the Authority at the latest six months after the date of publication of this Regulation. 3. The Authority shall give an opinion within six months of receipt of a valid application as to whether or not the recycling process complies with the conditions laid down in Article 4. 4. In the event of an opinion in favour of authorising the evaluated recycling process, the opinion of the Authority shall include the following: (a) a short description of the recycling process; (b) where appropriate, any recommendations on conditions or restrictions concerning the plastic input; (c) where appropriate, any recommendations on conditions or restrictions concerning the recycling process; (d) where appropriate, any criteria to characterise the recycled plastic; (e) where appropriate, any recommendations concerning conditions in the field of application of the recycled plastic; (f) where appropriate, any recommendations concerning monitoring compliance of the recycling process with the conditions of the authorisation. Article 6 Authorisation of recycling processes 1. The Commission shall adopt a Decision addressed to the applicant granting or refusing authorisation of the recycling process. Article 11(3) of Regulation (EC) No 1935/2004 shall apply. 2. The Decision shall take into account the opinion of the Authority, relevant provisions of Community law, and other legitimate factors relevant to the matter under consideration. Where the Decision is not in accordance with the opinion of the Authority, the Commission shall provide an explanation of the reasons for the differences. 3. The Decision granting the authorisation shall include the following: (a) the name of the recycling process; (b) the name and address of the authorisation holder(s); (c) a short description of the recycling process; (d) any conditions or restrictions concerning the plastic input; (e) any conditions or restrictions concerning the recycling process; (f) any characterisation of the recycled plastic; (g) any conditions in the field of application of the recycled plastic that has been manufactured by the recycling process; (h) any requirements concerning monitoring of the compliance of the recycling process with the conditions of the authorisation; (i) the date from which the authorisation is effective. 4. The Decision granting or refusing the authorisation shall be published in the Official Journal of the European Union. 5. The authorisation issued to the authorisation holder shall be valid throughout the Community. The authorised recycling process shall be entered in the Register referred to in Article 9(1). Article 7 Obligations arising from the authorisation 1. After the authorisation of a recycling process in accordance with this Regulation, the authorisation holder or any other business operator using the authorised recycling process under licence shall comply with any conditions or restrictions attached to such authorisation. Any converter using recycled plastic from the authorised recycling process or any business operator using materials or articles containing recycled plastic from the authorised recycling process shall comply with any condition or restriction attached to such authorisation. 2. The authorisation holder or any other business operator using the authorised recycling process under licence shall immediately inform the Commission of any new scientific or technical information, which might affect the safety assessment of the recycling process in relation to human health. If necessary, the Authority shall then review the assessment. 3. The granting of an authorisation shall not affect the general civil and criminal liability of any business operator in respect of the authorised recycling process, the material or article containing recycled plastic from the authorised recycling process, and the food that is in contact with such material or article. Article 8 Modification, suspension and revocation of authorisation of a recycling process 1. The authorisation holder may, in accordance with the procedure laid down in Article 5(1) apply for a modification of the existing authorisation. 2. The application referred to in paragraph 1 shall be accompanied by the following: (a) a reference to the original application; (b) a technical dossier containing the new information in accordance with the guidelines referred to in Article 5(2); (c) a new complete summary of the technical dossier in a standardised form. 3. On its own initiative or following a request from a Member State or the Commission, the Authority shall evaluate whether the opinion or the authorisation is still in accordance with this Regulation, in accordance with the procedure laid down in Article 5, where applicable. 4. The Commission shall examine the opinion of the Authority without delay and if necessary prepare a draft Decision to be taken. 5. A draft Decision modifying an authorisation shall specify any necessary changes in the conditions of use and, if any, in the restrictions attached to that authorisation. 6. If appropriate, the authorisation shall be modified, suspended or revoked in accordance with the procedure referred to in Article 6. Article 9 Community register 1. The Commission shall establish and maintain a Community register of authorised recycling processes. 2. The register shall be made available to the public. 3. Each entry in the register shall include the information referred to in Article 6(3). Article 10 Official control 1. The official control of a recycling plant and converter shall be performed in accordance with the rules laid down in Regulation (EC) No 882/2004 and shall include in particular audits as control technique as specified in Article 10 of Regulation (EC) No 882/2004. 2. The official control shall verify that the recycling process corresponds to the authorised process and that an effective quality assurance system in accordance with Regulation (EC) No 2023/2006 is in place. 3. The authorisation holder shall notify the competent authority in the Member State about the recycling or manufacturing site in which the authorised recycling process is being applied. Member States shall forward that information to the Commission. Manufacturing or recycling sites in third countries shall be notified to the Commission. The Commission shall make available and keep updated a register of recycling sites in the Community and third countries. Article 11 Labelling of recycled plastic materials and articles Voluntary self-declaration of the recycled content in recycled plastic materials and articles shall follow the rules laid down in ISO 14021:1999 or equivalent. Article 12 Declaration of compliance and record keeping 1. In addition to the requirements of Article 9 of Directive 2002/72/EC, the declaration of compliance of recycled plastic materials and articles shall contain the information laid down in Part A of Annex I to this Regulation. 2. In addition to the requirements of Article 9 of Directive 2002/72/EC, the declaration of compliance of recycled plastic shall contain the information laid down in Part B of Annex I to this Regulation. Article 13 Transitional measures for the authorisation of recycling processes 1. For the initial authorisation phase of recycling processes, the procedure provided for in Articles 5, 6 and 7 shall apply subject to paragraphs 2 to 6 of this Article. 2. During the 18 months following the publication of the guidelines for the safety assessment of a recycling process of the Authority as provided for in Article 5(2), business operators seeking authorisation shall submit an application in accordance with Article 5. 3. The Commission shall make available to the public a register of recycling processes for which a valid application has been submitted in accordance with paragraph 2. 4. The Authority shall issue an opinion on each recycling process for which a valid application has been submitted during the period referred to in paragraph 2 of this Article. The deadline of six months for issuing the opinion, as referred to in Article 5(3), shall not apply. 5. Applications for which the Authority could not issue an opinion owing to the applicant’s failure to comply with the time limits specified for submission of supplementary information in accordance with Article 10(2) of Regulation (EC) No 1935/2004 shall be excluded from consideration for the initial authorisation. 6. Within six months of receiving all the opinions referred to in paragraph 4, the Commission shall submit for opinion to the Standing Committee on the Food Chain and Animal Health draft decisions granting or refusing authorisation of the recycling processes referred to in paragraph 1. Article 14 Transitional measures for the trade in and use of recycled plastic 1. Trade in and use of recycled plastic from a recycling process already in place on the date of entry into force of this Regulation, for which authorisation is refused or for which no valid application has been submitted in accordance with Article 13 shall be permitted until six months after the date of adoption of the Decisions referred to in Article 13(6). 2. Trade in and use of recycled plastic materials and articles containing recycled plastic from a recycling process already in place on the date of entry into force of this Regulation, for which authorisation is refused or for which no valid application has been submitted in accordance with Article 13 shall be permitted until exhaustion of stocks. Article 15 Amendment to Regulation (EC) No 2023/2006 The Annex to Regulation (EC) No 2023/2006 is amended in accordance with Annex II to this Regulation. Article 16 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. However, Articles 3, 9, 10 and 12 shall apply from the date of the adoption of the Decisions referred to in Article 13(6). Until that date, national provisions in force concerning recycled plastic materials and articles and recycled plastic shall continue to apply in the Member States. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 27 March 2008. For the Commission Androulla VASSILIOU Member of the Commission (1) OJ L 338, 13.11.2004, p. 4. (2) OJ L 365, 31.12.1994, p. 10. Directive as last amended by Directive 2005/20/EC (OJ L 70, 16.3.2005, p. 17). (3) OJ L 220, 15.8.2002, p. 18. Directive as last amended by Directive 2007/19/EC (OJ L 91, 31.3.2007, p. 17). (4) OJ L 384, 29.12.2006, p. 75. (5) OJ L 165, 30.4.2004, p. 1; corrected version (OJ L 191, 28.5.2004, p. 1). Regulation as last amended by Commission Regulation (EC) No 180/2008 (OJ L 56, 29.2.2008, p. 4). (6) OJ L 44, 15.2.1978, p. 15. ANNEX I PART A Additional information in the declaration of compliance for recycled plastic materials and articles The written declaration referred to in Article 12(1) shall contain the following additional information: A declaration that only recycled plastic from an authorised recycling process has been used listing the EC Register number of the authorised recycling process. PART B Additional information in the declaration of compliance for recycled plastic The written declaration referred to in Article 12(2) shall contain the following additional information: 1. The declaration that the recycling process has been authorised listing the EC Register number of the authorised recycling process; 2. The declaration that the plastic input, the recycling process and the recycled plastic meet the specifications for which the authorisation has been granted; 3. The declaration that a quality assurance system according to Section B of Annex to Regulation (EC) No 2023/2006 is in place. ANNEX II The Annex to Regulation (EC) No 2023/2006 is amended as follows: (1) The following section title is inserted after the title: ‘A. Printing inks’ (2) The following section is added: ‘B. Quality assurance system for plastic recycling processes covered by Regulation (EC) No 282/2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006 1. The quality assurance system implemented by the recycler must give adequate confidence in the capability of the recycling process to ensure the recycled plastic meets the requirements in the authorisation. 2. All the elements, requirements and provisions adopted by the recycler for his quality assurance system must be documented in a systematic and orderly manner in the form of written policy statements and procedures. That quality system documentation must permit uniform interpretation of the quality policy and procedures, such as quality programmes, plans, manuals, records and measures taken to ensure traceability. It must include, in particular: (a) a quality policy manual, containing a clear definition of the recycler’s quality objectives, the organisation of the business and in particular the organisational structures, the responsibilities of the managerial staff and their organisational authority where manufacture of the recycled plastic is concerned; (b) the quality control plans, including those for input and recycled plastic characterisation, suppliers’ qualification, sorting processes, washing processes, deep cleansing processes, heating processes, or any other part of the process relevant for the quality of the recycled plastic including the choice of points which are critical for the quality control of the recycled plastics; (c) the managing and operative procedures implemented to monitor and control the whole recycling process, including the inspection and quality assurance techniques at all the manufacturing stages, especially the establishment of critical limits at the points which are critical for the quality of the recycled plastics; (d) the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired recycled plastic quality, including control of products which fail to conform; (e) the tests and analytical protocols or any other scientific evidence applied before, during and after recycled plastic production, the frequency with which they will take place, and the test equipment used; it must be adequately possible to trace back the calibration of the test equipment; (f) the recording documents adopted.’

Summary: Recycled plastic packaging in contact with food Recycled plastic packaging in contact with food Regulation (EC) No 282/2008 on recycled plastic materials and articles intended to come into contact with foods SUMMARY Plastic waste may be contaminated by substances from the previous use of the plastics or by contact with non-food grade plastic. Therefore an adequate process to remove possible contamination is necessary to control the safety of the final product. WHAT DOES THE REGULATION DO? This Regulation sets out specific measures for recycled plastic materials and articles, supplementing Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food. KEY POINTS This Regulation covers the use of recycled plastic materials and articles which come directly into contact with food. It does not apply to previously unused offcuts, or polymers which have been chemically broken down into monomers*, for example, removing their quality of plasticity. The materials and articles covered here are also subject to Regulation (EU) No 10/2011 on plastic materials intended for food packaging. The recycled plastic used for the manufacture of materials and articles covered by this Regulation must come from an authorised recycling process, managed according to rules set out in the Annex of Regulation (EC) No 2023/2006 on good practice for materials and articles intended to come into contact with food. Authorisation may be granted if recycling processes comply with the following: the input must be quality controlled; the input must originate from plastic materials made in accordance with EU legislation on plastic materials and articles intended for contact with food; the process must guarantee that there is no risk of contamination or that it is at a level posing no risk to health; the finished article must not release components into food in a quantity likely to endanger human health or cause an unacceptable change in the composition of the food, or a deterioration in its appearance, smell or texture. The European Commission (EC) keeps a public register of authorised recycling processes, as well as a register of recycling sites in EU and non-EU countries. Voluntary declaration of the recycled content in recycled plastic materials and articles follow the rules set out in ISO 14021:1999. In addition to meeting the requirements of Regulation (EU) No 10/2011, the declaration of compliance must confirm that: an authorised recycling process was used, and state its EC registration number, the plastic input, the recycling process and the recycled plastic meet the specifications for which the authorisation has been granted, and a quality assurance system is in place. KEY TERM *Monomer: a substance consisting of single unconnected molecules, in contrast to a polymer which gains its quality of plasticity from molecules in a monomer binding together. WHEN DOES THE REGULATION APPLY? From 17 April 2008. For more information, see Food Contact Materials on the European Commission's website. ACT Commission Regulation (EC) No 282/2008 of 27 March 2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006 REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EC) No 282/2008 17.4.2008 - OJ L 86, 28.3.2008, pp. 9–18 RELATED ACTS 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 (OJ L 338, 13.11.2004, pp. 4–17) 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) Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, pp. 1–89) last update 03.12.2015


17.8.2007 EN Official Journal of the European Union L 214/9 COUNCIL RECOMMENDATION of 12 June 2007 concerning sharing of information on terrorist kidnappings (2007/562/EC) THE COUNCIL OF THE EUROPEAN UNION, Whereas: (1) Kidnappings by groups/individuals that can be placed within the spectrum of international terrorism pose a huge challenge to Member States. (2) To successfully resolve such situations, Member States must gather background information, establish contacts and initiate discussions in a confidential setting. (3) The capacities of the Member State concerned would be significantly strengthened if it were able to resort to experience which other Member States have gained in comparable situations. (4) To this end, each Member State should submit a data sheet containing key information on past kidnappings to the other Member States giving only unclassified information after the incident has been resolved and restricted to incidents related to international terrorism, HEREBY RECOMMENDS, 1. Member States: (a) to submit, after a kidnapping incident has been resolved, the following data (1): — country and region in which the kidnapping took place, — number and nationality of the hostage(s), — time and date of the kidnapping, — time and date of the end of the incident, — perpetrators/responsible terrorist group, — modus operandi of the kidnapping, — motivation for the kidnapping, — involvement of a mediator yes/no, — contact person in the Member State concerned. This information should be submitted in accordance with the format set out in Annex 1. (b) to also submit the following additional information if appropriate: — hostages’ reason for being in the country, language skills, gender of the hostage, — ideology, nationality, language skills of the perpetrators, — means used by the perpetrators to address the public, — details on the perpetrators’ modus operandi. This optional information should be submitted in accordance with the format set out in Annex 2. 2. If personal data are to be included, such data are to be submitted in accordance with national law. 3. Member States to compile information on all incidents which have occurred since 1 January 2002 and submit this summary to the other Member States. 4. Member States to share information on the basis of the abovementioned principles through the BdL network for EU-wide information sharing on terrorist incidents. 5. Member States to share, as far as possible, the information also with Europol and on the basis of the amount and type of shared data, after one year, to examine whether it would be advisable to set up a database at Europol. 6. Member States to draw up a list of contact details and exchange this list in order to facilitate direct communication between contact points. (1) In case of a kidnapping this information could help to quickly identify whether another Member State already has experience with kidnappings of EU citizens in the same region, by the same terrorist group or under comparable circumstances. The Member State concerned can then contact the specified contact person. Further information and experience should be shared bilaterally in accordance with national law. ANNEX 1 Notification of terrorist kidnap (or suspected terrorist kidnap) Please complete all fields in this box ANNEX 2 Completion of the following information is optional in accordance with national law

Summary: Terrorist kidnappings — sharing information Terrorist kidnappings — sharing information SUMMARY OF: Council recommendation on sharing of information on terrorist kidnappings SUMMARY WHAT DOES THIS RECOMMENDATION DO? It sets out a procedure for the sharing of experiences between EU countries to help resolve terrorist kidnapping situations. KEY POINTS Terrorist kidnappings pose a huge challenge to EU countries. To successfully resolve such situations, countries need background information, to establish contacts and initiate confidential discussions. Sharing information can quickly identify whether another EU country already has helpful experience with kidnappings in the same region, by the same terrorist group or in similar circumstances. To achieve this, each EU country is recommended to circulate data sheets to other EU countries on any terrorist kidnapping, after the incident has been resolved. This information should include: country and region in which the kidnapping took place; number and nationalities of the hostages; time and date of the kidnapping and its conclusion; responsible terrorist group or perpetrator; kidnapping method; motivation for the kidnapping; any mediator involvement; contact person in the EU country concerned. The following additional information should also be supplied where appropriate: the hostages’ reason for being in the country, their language skills and gender; the ideology, nationality and language skills of the perpetrators; means used by the perpetrators to address the public; details on the perpetrators’ method of operation. Annexes to the recommendation propose a standard format for this information, as well as suggestions for additional information to be supplied, such as negotiating strategy, delaying tactics and whether ransoms or political demands were involved. Further information and experience should be shared bilaterally in accordance with national law. Handling of personal data should also be in accordance with national law. Each EU country should compile information on any incidents occurring since 1 January 2002 and supply a summary to other EU countries. A list of contact persons should also circulate in order to facilitate direct communication. Information should be shared through the bi-directional link network for EU-wide information sharing on terrorist incidents (see Council Decision 2005/671/JHA). Information should also be shared with Europol, with a review after 12 months to determine whether the amount and type of data requires a database. BACKGROUND For more information, see: ‘Crisis and Terrorism’ on the European Commission's website ‘Fight against terrorism’ on the website of the Council of the European Union ACT Council Recommendation of 12 June 2007 concerning sharing of information on terrorist kidnappings (OJ L 214, 17.8.2007, pp. 9-12) RELATED ACTS Council Decision 2005/671/JHA of 20 September 2005 on the exchange of information and cooperation concerning terrorist offences (OJ L 253, 29.9.2005, pp. 22-24). last update 03.05.2016