MINIMUM CRITERIA FOR REACH AND CLP INSPECTIONS 1

FORUM FOR EXCHANGE OF INFORMATION ON ENFORCEMENT Adopted at the 9 th meeting of the Forum on 1-3 March 2011 MINIMUM CRITERIA FOR REACH AND CLP INSPECTIONS 1 MARCH 2011 1 First edition adopted at the 6 th meeting of the Forum on 8-10 December 2009

Contents Introduction.. 1 1. Purpose... 3 2. Definitions.. 3 3. Scope and general principles.. 5 4. Enforcement strategies... 6 5. Organisation... 6 6. Planning.. 7 7. Carrying out REACH and/or CLP inspection 9 8. Action following REACH and/or CLP inspection 10 9. Checking and review of national arrangements. 11 10. Reporting.. 11 11. Review of the minimum criteria... 11 Introduction (i) (ii) (iii) (iv) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) entered into force on 1 June 2007. It introduced a new system for controlling chemicals across the EU., Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 concerning the classification, labelling and packaging of substances and mixtures (CLP) entered into force on 20 January 2009. The CLP Regulation made amendments to Regulation (EC) No 1907/2006 and will repeal the Directives 67/548/EEC and 1999/45/EC on 1 June 2015,. In order to enable the system introduced by REACH and CLP to operate effectively in practice, Member States are obliged to establish the necessary arrangements for its implementation and enforcement. One of the most important elements of the overall enforcement of both Regulations is inspection. Recital 121 of REACH and recital 59 of CLP states that Member States should put in place effective monitoring and control measures. Article 125 of REACH and Article 46 of CLP requires Member States to maintain a system of official controls and other activities as appropriate to the circumstances, and Article 126 of REACH and Article 47 of CLP requires Member States to lay down the provisions on penalties applicable for infringement of REACH or CLP which must be effective, proportionate and dissuasive. Under Articles 117(1) and 127 of REACH, the results of inspections, monitoring, penalties and other measures are to be reported to the European Commission by 1 June 2010 and after that every five years. Article 46(2) of CLP states that the Member States shall submit a report to the Agency (ECHA) every five years (by the 1 July) on the results of the official controls and other enforcement measures taken. Recital 120 of REACH and recital 61 of CLP also recognise the need for good cooperation, coordination and exchange of information between the Member States, the European Chemicals Agency (ECHA) and the European Commission. REACH establishes, in Article 76, a Forum for Exchange of Information on Enforcement ( the Forum ), which is allocated certain tasks such 1

as coordinating harmonised enforcement projects, identifying enforcement strategies and best practice in enforcement, developing working methods and tools for inspectors, and developing an electronic information exchange procedure. Article 46(3) of CLP states that this Forum also shall undertake those tasks in respect of the enforcement of CLP. (v) (vi) (vii) (viii) (ix) Different systems and practices of inspection exist in Member States and this document does not propose that they be replaced by a system of inspection at EU level. Member States should retain responsibility for REACH and CLP inspection activities. Instead, the purpose of this document is to establish guidelines, in the form of minimum criteria, to be applied as a common basis for the performance of REACH and CLP inspection activities within the Member States and EEA-EFTA States. This is consistent with some of the principle tasks of the Forum under Articles 76(1)(f) and 77(4) of REACH to coordinate a network of Member States authorities responsible for the enforcement of REACH, and to identify best practice in enforcement. The Forum is also responsible for coordinating a network of authorities responsible for the enforcement of CLP according to Article 46(3) of CLP. The Forum has, since its establishment, mandated a number of Working Groups to carry forward various elements of its work programme. References are made to the work of existing Forum Working Groups where appropriate and, in particular, the Forum document Strategies for enforcement of Regulation (EC) no. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and of Regulation (EC) no. 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP) as adopted in March 2009 by the Forum and subsequently revised. The minimum criteria for REACH and CLP inspections elaborated in this document have been created to be consistent with the output of other Forum Working Groups and, in particular, are intended to operate alongside the enforcement strategies document on an equal footing. Minimum criteria have already been set for environmental inspections under the Recommendation no. 2001/331/EC of the European Parliament and the Council of 4 April 2001 providing for minimum criteria for environmental inspections (RMCEI), as elaborated by the European Union Network for the Implementation and Enforcement of Environmental Law (IMPEL) and already adopted by the majority of the Member States. Although not directly applicable to REACH and CLP, the RMCEI provides a useful foundation upon which a structured system for REACH and CLP inspections can be created. REACH and CLP fall within the scope of Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance ( the AMS Regulation ), insofar as there are no specific provisions with the same objective, nature or effect in REACH or CLP. Member States must therefore ensure that REACH and CLP are included within their overall provisions for the implementation of the AMS Regulation. To this effect, this document is designed to incorporate, and be consistent with, the relevant requirements of the AMS Regulation. Implementation of the minimum criteria for REACH and CLP inspections should therefore achieve the relevant requirements of the AMS Regulation (insofar as these can be met without further legislation being required within the Member State). When considering REACH and CLP in the context of the 2

AMS Regulation, Member States should ensure that equal prominence is given to both environmental protection and human health. (x) The Forum mandated a Working Group in December 2008 to develop minimum criteria for REACH inspections, in order to ensure the level playing field within the internal market and the better co-ordination of REACH enforcement within Member States and EEA-EFTA States. In May 2010 the Forum mandated a Working Group to update these minimum criteria so that they covered also CLP inspections among other things. This document represents the output of these Working Groups, as ultimately adopted by the Forum. 1. Purpose 1. REACH and CLP inspection activities should be carried out in Member States following minimum criteria to be applied in the effective organisation, planning, implementation, carrying out and review of such tasks, thereby strengthening duty holder compliance with REACH and CLP, as well as contributing to more harmonised enforcement. These are key factors in realising the objectives of REACH and CLP to ensure a high level of protection of human health and the environment as well as the free movement of substances while enhancing competitiveness and innovation. 2. This document is addressed to enforcing authorities (and other public authorities as appropriate) in Member States with responsibilities for the matters contained within this document. 1. In this document 2. Definitions a) REACH means Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (OJ L 396, 30.12.2006, p1) as amended. b) CLP means Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 concerning the classification, labelling and packaging of substances and mixtures (OJ L 353, 31.12.2008, p1) as amended. c) the AMS Regulation means Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance (OJ L 218, 13.8.2008, p30). d) REACH and CLP inspections means the range of activities an enforcing authority may undertake in order to assess, secure or promote a dutyholder s compliance with REACH and/or CLP. Such activities may be routine (proactive) or non-routine (reactive), and include inspection, investigation, monitoring, formal enforcement and other measures taken in pursuance of 3

Articles 125 and 126 of REACH and of Articles 46 and 47 of CLP, as defined in the following sub-paragraphs: (i) (ii) (iii) (iv) inspection refers to a proactive (planned and routine) process that involves collecting information to make an assessment of a dutyholder s current level of compliance, by comparing their activities to the legal requirements and benchmark standards relevant to the activities in question. Information may be obtained by reviewing relevant documents held by the dutyholder or available to the enforcing authority, and/or interviewing people, and/or monitoring, and/or observing site conditions, standards or practices where activities subject to the requirements of REACH and CLP are carried out under the dutyholder's control. It follows that REACH and CLP inspection activity can occur at or away from a dutyholder s premises. investigation refers to a reactive (non-routine) process which includes all those activities carried out in response to an accident, incident, complaint, referral from another enforcing authority or public body, or an identified non-compliance, to gather and establish the facts, detect contraventions of REACH or CLP duties, identify immediate and underlying causes and the lessons to be learned, prevent recurrence, and take appropriate action, including formal enforcement. monitoring means periodic or continuous surveillance, measurement, sampling, testing and/or analysis of various media, such as substances, mixtures, articles, the environment (air, water, soil, vegetation, animals) and so on, to determine the level of compliance with statutory requirements. formal enforcement refers to a range of enforcement activity an enforcing authority is statutorily empowered to take, such as bringing legal proceedings by criminal or civil means, serving enforcement notices or other such administrative penalties (such as undertakings or on-the-spot fines), issuing formal cautions, and so on. e) enforcing authority means any public authority at national, regional or local level, which is established or designated by the Member State and is responsible for enforcement of the matters that are covered by this document. f) the Forum means the Forum for Exchange of Information on Enforcement, as established by Article 76(1)(f) of REACH. g) dutyholder means any person (whether natural or legal) with obligations under REACH or CLP, other than enforcing authorities, Competent Authorities, the European Chemicals Agency (ECHA) or the European Commission. h) target group means a group of dutyholders who exercise a particular activity and have a characteristic set of obligations according to REACH or the CLP. Regulations. Target groups under REACH and/or CLP are manufacturers, importers, distributors, only representatives (under REACH) and downstream users of substances, mixtures or articles. i) risk analysis means the determination of the impact and the probability of non-compliance with REACH and/or CLP requirements in order to consider 4

how this should influence the priorities of enforcing authorities. Impacts include environmental, occupational health and safety, public health, consumer protection and economic effects. Probability could be assumed as a function of the level of awareness and knowledge and the level of acceptance of REACH and CLP by the target groups, combined with their estimation of the economic implications of complying with REACH and/or CLP, the probability of being found in non-compliance, the probability of sanctions being imposed by enforcing authorities, and the possibility of adverse public reaction. j) risk assessment is the estimation of the acceptability of the risk determined by the risk analysis. If the risk is unacceptable, preventive or correction measures have to be applied. k) product shall have the meaning assigned to it under Article 15(4) of the AMS Regulation. l) market surveillance shall mean the activities carried out and measures taken by enforcing authorities according to chapter III of the AMS Regulation. 2. All references to Member States in this document should be read as including EEA-EFTA States unless otherwise provided. 3. Other expressions used in this document which are used in REACH or CLP have the same meaning that they bear in REACH or CLP. 3. Scope and general principles 1. This document applies to all REACH and CLP inspection activities undertaken by the enforcing authorities of Member States that are intended to address issues of compliance with REACH and CLP by all dutyholders whose activities are subject to its requirements. 2. In determining how best to implement the minimum criteria for REACH and CLP inspections as set out in this document, enforcing authorities should have regard to the following general principles: a) REACH and CLP should be effectively enforced, but in ways which minimise the burden of checking compliance for both dutyholders and for enforcing authorities. b) Comprehensive risk analysis should be used to ensure that enforcing authorities concentrate their resources on the areas that need them the most. Risk analysis in this context should follow the principles laid down in the document Strategies for enforcement of Regulation (EC) no. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and of Regulation (EC) No 1272/2008 ot the European Parliament and of the Council of 16 December 2008 concerning the classification, labelling and packaging of substances and mixtures as adopted by the Forum. In particular, risk analysis should be based on all available relevant and good-quality data. 5

c) Enforcing authorities should respond proportionately to identify contraventions of REACH or CLP, and within the framework of their enforcement policies, in order to deliver desirable regulatory outcomes. In particular, enforcing authorities should ensure that products which present a serious risk requiring rapid intervention, including a serious risk where the effects are not immediate, are treated in accordance with the requirements of Articles 20 and 29 of the AMS Regulation (inter alia, recalling, withdrawing or destroying such products or prohibiting them from being made available on the market). d) Dutyholders should be helped and encouraged to understand and meet their obligations under REACH and CLP more easily. This includes the provision of readily accessible advice and guidance. e) Enforcing authorities shall carry out their duties independently, impartially and without bias. 4. Enforcement strategies In order to be able to have a structured and transparent approach to REACH and CLP enforcement, an appropriate enforcement strategy or strategies should be developed. The strategy or strategies should use the general framework as described in the document Strategies for enforcement of Regulation (EC) no. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and of Regulation (EC) no. 1272/2008 of the European Parliament and of the Council of 16 December 2008 concerning the classification, labelling and packaging of substances and mixtures as adopted by the Forum.. 5. Organisation 1. Appropriate provisions should be made to ensure, as far as is reasonably practicable, that enforcing authorities cooperate and exchange information (as mentioned in Article 122 of REACH and Article 43 (2) of CLP) with: a) other enforcing authorities within their Member State; b) their Competent Authority or Authorities; c) enforcing authorities or Competent Authorities in other Member States; and d) the European Chemicals Agency; where this will facilitate compliance with, or the effective enforcement of REACH and CLP (with reference to the requirements of the AMS Regulation, insofar as there are no specific provisions with the same objective, nature or effect in REACH or CLP) in the Member States. 2. Where not already provided for by national law, formal arrangements should be devised and implemented as appropriate that provide for clear and effective cooperation and information exchange between enforcing authorities within a Member State (where there is more than one enforcing authority responsible for the enforcement of REACH and CLP). Such arrangements should contain provisions as to: 6

a) joint working should enforcement responsibilities overlap; b) the sharing of information between enforcing authorities regarding their REACH and CLP inspection activities and issues giving rise to concern, and the manner in which this is to be achieved. The electronic information exchange system adopted by the Forum for the purposes of REACH and CLP enforcement should be used for fast and easy exchange of information; c) co-operation and information exchange with customs authorities (where customs authorities are not already a designated REACH and/or CLP enforcing authority within a Member State); d) notification between enforcing authorities of identified matters of concern regarding dutyholders; e) supporting each other with enforcement, and where appropriate the provision of specialist advice; and f) if appropriate, the establishment of national, regional and/or local networks or fora for enforcement liaison. 3. Information about the enforcing authorities, their tasks and responsibilities and how they may be contacted should be publicly available in all Member States. 4. Matters of concern identified through REACH and/or CLP inspection activity that relate to the compliance of dutyholders based in other Member States, or that appear to raise significant cross-border issues, should be communicated as soon as possible via the electronic information exchange system adopted by the Forum for the purposes of REACH and CLP enforcement. Information on general enforcement issues with Community-wide interest should be exchanged via the Forum. 5. Enforcing authorities should disclose to the bodies referred to in paragraph (1) information they hold in relation to compliance with, or the enforcement of, REACH and/or CLP where they believe: a) it is reasonable to make that disclosure; b) such disclosure is lawfully allowed by national legislation; and c) the disclosure will facilitate compliance with, or the effective enforcement of, REACH and CLP in Member States. 6. Enforcing authorities should ensure that they make appropriate resources available for REACH and CLP inspection, and that inspectors (and other relevant staff as may be necessary) have suitable qualifications and have been given the necessary powers to enforce those parts of REACH and/or CLP for which they have enforcement responsibility. Suitable training and up to date support materials should be provided to those involved in REACH and/or CLP inspection. 6. Planning 1. Enforcing authorities should ensure that their REACH and CLP inspection activities are planned in advance, by having at all times an inspection plan or plans, 7

collectively taking into account all the territory of the Member State and of the known target groups. 2. Such plan or plans may be established at national, regional or local levels, but enforcing authorities should ensure that the plan or plans apply to all of their REACH and CLP inspections and that the plans have regard to the strategy or strategies developed in accordance with section 4 above. 3. Plans for REACH and CLP inspection should be produced on the basis of the following: a) the enforcing authorities objectives and targets, their overall statutory responsibilities and competencies, and the provisions of REACH and/or CLP they are responsible for enforcing; b) the known dutyholders / target groups within the area(s) covered by the plan; c) the resources available to the enforcing authorities; d) a general analysis of major public, occupational health and environmental risks within the area(s) covered by the plan, taking into account the hazards arising from the activities of the dutyholders / target groups, the likelihood of the hazards occurring, and the vulnerability of those who could be affected by those activities (workers, the general public, the environment); e) a general appraisal of the likelihood of non-compliance by the dutyholders / target groups with REACH and/or CLP requirements, taking into account factors such as previous inspection records and potential future risks. 4. Plans for REACH and CLP inspection should: a) be appropriate to the inspection tasks / competencies of the relevant enforcing authorities; b) take into account the number and size of the different dutyholders / target groups concerned; c) take into account relevant existing information in relation to specific dutyholders, such as safety data sheets, chemical safety reports, information used for the purposes of classification and labelling, other information available from the electronic information exchange system (as adopted by the Forum) or from REACH-IT or RIPE, results of previous inspections, or information kept and made available by the dutyholders according to Article 36 of REACH or Article 49 of CLP; d) consider the amount and suitability of existing information available to the enforcing authority, and the need for further work to better identify dutyholders / target groups and gather intelligence on supply chain information, so as to provide for more effective risk analysis, and targeting and use of resource; and e) give priority to measures that are designed to achieve an effective outcome in terms of compliance, based on risk analysis. 5. Each plan for REACH and/or CLP inspection should, as a minimum: 8

a) define the geographical area which it covers, which may be for all or part of the territory of a Member State; b) cover a defined time period, for example one year; c) provide for co-ordination, co-operation, communication and information exchange in accordance with section 5 above; d) provide for routine (proactive) REACH and/or CLP inspection, which identifies the specific dutyholders / target groups covered and which describes the scope and, if possible, the frequency of the inspection; e) provide and outline the procedures for non-routine (reactive) REACH and/or CLP inspection, ensuring that appropriate resources can be set aside as necessary; and f) include specific provisions for its revision. 7. Carrying out REACH and/or CLP inspection Enforcing authorities should apply the following criteria in respect of all REACH and/or CLP inspection: a) that the role of the dutyholder is correctly identified (in terms of which of the target groups they belong to); b) that an appropriate check is made of compliance with the REACH and/or CLP requirements relevant to the particular scope of the inspection and according to the role of the dutyholder (i.e. to the different obligations of the target groups registration, information in the supply chain, use, authorisation, restriction, classification, labelling, notification or other REACH or CLP duties as appropriate); c) that if site visits are to be carried out by more than one enforcing authority, then as far as possible they exchange information on each others' activities and co-ordinate site visits and other REACH and/or CLP inspection work; d) that the findings of the inspections are contained in reports which contain the information needed by the Member State for the purposes of reporting under Article 117(1) of REACH (with reference to Article 127) and under Article 46 of CLP. Such reports should be exchanged as necessary between relevant enforcing authorities, Competent Authorities and other bodies, on an international, national, regional or local level by using the electronic information exchange system (as adopted by the Forum); e) the essential requirements of REACH and CLP, as prioritised in the national REACH and CLP enforcement strategies, relevant for the given dutyholder / target group are examined, in accordance with REACH and CLP requirements, the inspection plan(s) and the enforcing authorities responsibilities and competencies; f) that the inspections promote dutyholders' knowledge and understanding of their duties under REACH and CLP, and ensure dutyholder compliance (using formal enforcement where appropriate); 9

g) that the risks to, and impact on, human health and the environment are considered; h) that complaints received by enforcing authorities and made by third parties, who make allegations relating to the compliance of a particular dutyholder or dutyholders, are investigated as soon as possible after such complaints are received, in line with any relevant selection criteria that enforcing authorities may apply; i) that serious accidents or incidents are investigated without undue delay after these come to the notice of the relevant enforcing authorities, in line with any relevant accident or incident selection criteria they may apply; j) that products identified during REACH and/or CLP inspection activities which present a serious risk requiring rapid intervention, including a serious risk where the effects are not immediate, are treated in accordance with the requirements of Articles 20 and 29 of the AMS Regulation; k) that, if hazards are identified related to any product, the enforcing authorities shall take measures to alert users by using the appropriate procedures as required by Article 19(2) of the AMS Regulation; l) that recall or withdrawal of products, or prohibitions on making products available on the market, has to be carried out according to the provisions of Articles 19 to 29 of the AMS Regulation; and m) that enforcing authorities preserve confidentiality where necessary in order to protect commercial secrets or to preserve personal data pursuant to national legislation, although this shall not prevent the dissemination of relevant information to relevant enforcing authorities and to the public as necessary, in order to protect the interests of users in the Community. 8. Action following REACH and/or CLP inspection 1. Enforcing authorities should ensure that after every inspection without unnecessary delay relevant inspection reports are produced and stored, which as a minimum contain: a) basic data on the inspection (for example, the date, name of the inspector(s), scope of the inspection, details of the dutyholder etc); b) the significant findings of the REACH and/or CLP inspection; c) a comparison of the findings with the legal requirements, relevant to the dutyholder / target group concerned; d) an evaluation thereof, identification of any non-compliance, and a conclusion on whether any further action should follow, such as formal enforcement or further inspections; and e) the measures taken pursuant to the REACH and/or CLP inspection, by the enforcing authority and/or by the dutyholder. 10

2. The inspection reports should be properly recorded in writing and kept in an accessible and retrievable format. The reports should be communicated to dutyholders promptly with clear explanations of what action they are required to take. 3. The enforcing authorities should ensure that if a dutyholder is required to take action in response to an inspection, then appropriate checks are made where necessary to ascertain that the required action has been taken, and as soon as possible after the expiry of any deadline given to the dutyholder. The failure of the dutyholder to complete the activities required should result in further enforcement action to ensure compliance. 9. Checking and review of arrangements for REACH and/or CLP inspection Enforcing authorities should regularly check and review the success of their arrangements for REACH and CLP inspections, including the elements of organisation, planning and carrying out, using appropriate performance indicators. If necessary, the arrangements should be updated in order to further the effectiveness of REACH and CLP inspections. 10. Reporting Enforcing authorities should ensure that appropriate systems are in place to facilitate the collection and collation of relevant information on REACH and CLP inspection activities. For these purposes, relevant information means as a minimum the enforcement-related information that is required to be submitted to the European Commission for the purposes of reporting under Article 117(1) of REACH (with reference to Article 127) and under Article 46 of CLP, and as elaborated by the Forum through its Working Group on the Member States Report to the Commission. 11. Review of the minimum criteria 1. The Forum should review the operation and effectiveness of this document no later than the end of December 2010 and thereafter at least once every five years, with the intention of developing the minimum criteria further in terms of their scope and application. This will be undertaken in the light of the experience gained from their application, and taking into account any contributions from interested parties, including Member States, the European Commission and the European Chemicals Agency. 2. The Forum may review this document more frequently than the minimum timescales set out above if it so chooses. The review may also include a review of all, or a selection of, the approaches of Member States to implementing the minimum criteria, in order to identify and spread best practice for REACH and CLP enforcement, in line with the requirements of Article 77(4) of REACH. 11