2011 Annual Report of Enforcement of REACH and EU-GHS in the Netherlands

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1 2011 Annual Report of Enforcement of REACH and EU-GHS in the Netherlands

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3 Contents 1. Introduction Legislation and method of enforcement 05 3 Enforcement programme in Supporting activities 13 5 European activities 14 6 Conclusions and recommendations Annual Report of Enforcement of REACH and EU-GHS in the Netherlands 03

4 1 Introduction A joint organisation called the REACH Enforcement Centre (RHR) was established in 2007 by the then Labour Inspectorate (AI), the Food and Consumer Product Safety Authority (VWA), and the VROM Inspectorate (VI) to enforce REACH1. These organisations were renamed on 1 January 2012 and are now the Inspectorate SZW (I-SZW), the Netherlands Food and Consumer Product Safety Authority (NVWA), and the Human Environment and Transport Inspectorate (ILT), respectively. RHR consists of a REACH Enforcement Steering Committee (StHR) and a Joint REACH Enforcement Unit (SHR). This cooperation was expanded in 2009 by adding the enforcement of EU-GHS2, and the names were changed to StHRG and SHRG, respectively. StHRG exists to promote mutual harmonisation as well as uniformity and simplification of supervision. The powers of StHRG are to determine and to adjust the enforcement strategy and a multi-year enforcement programme, and to set down the arrangements agreed for joint enforcement. SHRG is not a separate entity, but a working structure. It is responsible for making preparations, providing support, and maintaining internal contacts (with inspectorates and ministries involved in REACH) as well as external contacts concerning enforcement of REACH and EU-GHS. In 2011, the aforementioned inspectorates enforced REACH and EU-GHS as part of their multi-year approach, as in previous years. This report describes the results of the enforcement activities undertaken. 1 2 See Chapter 2 for further details See Chapter 2 for further details 2011 Annual Report of Enforcement of REACH and EU-GHS in the Netherlands 04

5 2 Legislation and method of enforcement The REACH Regulation came into force on 1 June This European Regulation regulates the registration, evaluation and authorisation of chemical substances, preparations and objects. In the Netherlands, the REACH Regulation is enforced under Chapter 9 of the Environmental Management Act (Wm)4 and under the Commodities (Chemical Product Safety) Decree. This arrangement superseded the Environmentally Hazardous Substances Act (Wms). REACH identifies different roles in the substances supply chain. The roles are linked to the activities that companies carry out with substances (production, import, use, and distribution). Companies may fulfil the role of manufacturer, importer, user (downstream user), or distributor. A combined role is also possible. An importer may also fulfil the role of distributor, while a manufacturer may also be a user of a substance. Depending on the role(s) that a company fulfils, REACH imposes various obligations. The group of users includes four distinct subgroups: formulators, industrial users, professional users, and manufacturers of objects. new Chapter 9 of the Environmental Management Act7. EU-GHS is focused on the same target groups and roles in the supply chain as those described under REACH. The Globally Harmonised System of Classification and Labelling of Chemicals (GHS) is a new system that has been harmonised worldwide in order to classify and label chemical substances and preparations (called mixtures in GHS). The system was developed by the United Nations and was introduced in the European Union (EU) at the start of To allow introduction of these rules for the supply and use of chemical substances in the EU, the European Commission drew up a new European Regulation on Classification, Labelling and Packaging (CLP) of substances and mixtures (which was given the Dutch working title of EU-GHS). This new Regulation will replace the prevailing directives governing the classification, labelling and packaging of substances and mixtures (Substances Directive 67/548/ EC and Preparations Directive 1999/45/EC), and will amend the REACH Regulation (1907/2006) as well5. The definitive EU-GHS Regulation6 was published on 31 December 2008 and entered into force shortly afterwards on 20 January In the Netherlands, implementation and enforcement of the EU-GHS Regulation is regulated under the Each inspectorate maintains supervision over these target groups in respect of all (primary) aspects of the REACH and EU-GHS Regulations, and heads enforcement projects focused on those target groups. Enforcement programmes seek to achieve good harmonisation and cooperation between the enforcement projects undertaken by the inspectorates concerned. Target groups are allocated in line with the target groups of the relevant inspectorate. In fields of work overlap, the inspectorates consult with each other to assign supervision to one particular inspectorate 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), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/ EEC, 93/105/EC and 2000/21/EC (Office Journal of the European Union L136, of 29 May 2007) Netherlands Bulletin of Acts and Decrees No. 181, 2007 See Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No. 1907/2006 As REACH and the EU-GHS Regulation are both part of the new European chemical substances policy and are so closely interrelated, it was decided to align enforcement of EU-GHS as closely as possible to REACH enforcement in terms of strategy, programming, and organisation. Enforcement is handled by the separate inspectorates of I-SZW, NVWA, and ILT. They cover all focus areas in the supply chain (target groups). Responsibilities have been distributed in the following way: I-SZW: Industrial and professional users8 NVWA: Manufacturers, importers and traders of consumer preparations and objects ILT: Manufacturers, importers and traders of substances and preparations for professional use Besides the inspectorates already mentioned, the Customs administration and State Supervision of Mines (SodM) also play a role. Coordination, consultation, and the exchange of information between EU Member States on REACH and EU-GHS enforcement take place in the Forum, the formal collaboration platform for European regulators9. This is located at and supported by the European Chemicals Agency (ECHA). The task of the Forum is threefold: Advise on the practicability and enforceability of the implementing rules of REACH and EU-GHS Exchange enforcement information between Member States Prepare, carry out and coordinate joint enforcement projects by EU Member States Netherlands Bulletin of Acts and Decrees No. 440, 2009 Industrial users are companies in the wood trade, car making, IT, agriculture, and similar; Professional users are service-providing companies Under Article 76 of the REACH Regulation and Article 43 of the EU-GHS Regulation 2011 Annual Report of Enforcement of REACH and EU-GHS in the Netherlands 05

6 3 Enforcement programme in 2011 NVWA and ILT checked compliance with the REACH and EU-GHS legislation by manufacturers, importers, and traders. I-SZW concentrated on elaborating the REACH enforcement policy in relation to working conditions, and made compliance checks among users. SodM carried out inspections at mining companies in respect of obligations under the REACH and EU-GHS legislations, while Customs provided support for ILT s inspection work by such means as supplying information about imports, and checking imports of products containing cadmium. The sections that follow describe the results of joint and individual supervision activities. A pilot project was carried out in 2011 jointly by I-SZW, NVWA, and ILT in the supply chain of polishes used in the automotive industry (i.e. formulators, suppliers and professional users of such polishes). A report on this project will be issued in Full company inspections performed by NVWA and ILT regarding REACH and EU-GHS ILT and NVWA carried out inspections to determine to what extent manufacturers, importers, and traders were complying with the REACH and EU-GHS legislation. Companies were randomly selected for comprehensive inspection in the basic REACH industrial database that contains more than 4,200 companies. A total of 131 companies with REACH obligations were inspected: 65 by NVWA and 66 by ILT. These companies underwent a full check on registration/ preregistration10, presence of information, labelling and Safety Data Sheets (SDSs), and the forwarding of the information to parties further down the supply chain. It was also established which role or roles a company has in the context of REACH. For specific reasons, the checks at six companies were confined to the registration obligation under REACH legislation. The table below shows the subdivision of roles, whereby one and the same company may fulfil several roles. This may result in a duplication of the number of companies. The total number of individually inspected companies (131) is therefore slightly smaller than indicated in the table. It should be noted that all inspected companies were familiar with the REACH legislation. 10 Registration means the REACH obligation to submit substances data (risks) to the European Chemicals Agency (ECHA) Role in REACH chain Manufacturer of substance Importer of substance/preparation Number of companies fully inspected in respect of REACH NVWA ILT Total Trader Manufacturer/formulator of preparation Total Only Representative Obligation to register Infringements of the registration/preregistration obligation and related matters (intermediates, performance of tests) were observed at 10 of the 92 companies that were inspected in respect of this matter (i.e. 11% of all cases). Charges were brought in one of these cases, and proceedings were initiated under administrative law in five cases. In four cases, the companies took immediate action, the infringements ceased, and no administrative law proceedings needed to be initiated. Availability and quality of Safety Data Sheets and labelling At 111 of the 131 inspected companies14, there were checks on the presence and completeness of SDSs. At 98% of the inspected companies, the mandatory SDSs were available, and 94% had them in the correct language. Almost all companies inspected in respect of this matter were found to have drawn up SDSs in accordance with Annex II of REACH (16 legally required sections). At 15% of the inspected companies, the quality of the SDSs was unsatisfactory in terms of the legally required information (Section 15: labelling in accordance with EC directives). During their inspections, NVWA and ILT also examined adherence to the EU-GHS Decree as well as the Further Requirements for Packaging and Identification (BVA/NVA). Labelling was examined at 96 of the 131 inspected companies. It was found that 96% of the examined labelling was in the correct language. At 18 of the 96 Only Representative (OR): Article 8 of REACH allows companies outside the EU to use an OR (in the EU) to submit the registrations and pre-registrations 12 A company may perform several roles, so this may cause a duplication of the number of companies 13 A company may perform several roles, so this may cause a duplication of the number of companies 14 Various reasons may exist for not checking the SDS (label) at all companies; e.g. a company does not supply products to third parties, a company delivers via a different site, or a company was inspected earlier in respect of this matter Annual Report of Enforcement of REACH and EU-GHS in the Netherlands 06

7 inspected companies (19%), the contents of the labelling were not entirely complete. The observed irregularities in the SDSs and labelling resulted in the following measures: 36 warnings, 17 advance notices of fines, and one official charge. A follow-up was carried out depending on the severity of the infringement. 3.2 Inspections performed by NVWA and ILT concerning prohibited substances The results of inspections of SDSs and labels in 2011 show slightly better compliance than in 2008, 2009, and 2010 (based in each instance on a random sample); see the table below. Results of inspections by ILT In 2011, ILT inspected 74 companies in total for compliance with the prohibitions on substances stated in Annex XVII (see the table below). Year Compliance percentage SDS in correct language 2008 In 2011, NVWA performed no projects targeted at substances subject to a prohibition under Annex XVII of the REACH Regulation. ILT did undertake such projects, however. 90 SDS Section 15 complete 72 Prohibition Label in correct language 92 Label correct Number of companies inspected in respect of prohibitions under Annex XVII of REACH 80 Cadmium Asbestos PAHs in car tyres PFOS in extinguishing foam 33 Total 74 Provision of information by means of Safety Data Sheets The checks revealed that workers at almost all inspected companies (95%) had access to information about substances and preparations (Article 35 of REACH). Around 80% of the inspected companies passed on the information to parties including traders and end-users further on in the supply chain (Article 34 of REACH). Specific sub-activities In 25 inspections, a key spearhead was whether chemical intermediates were being used within the production chain under strictly controlled conditions within the meaning of the REACH Regulation. This was not entirely the case at 30% of the examined cases. These companies received letters under administrative law and will be re-inspected in 2012 in relation to this matter. In the case of pre-mixes (mixtures of, among other things, vitamins and minerals for addition to animal feed), it emerged in 2009 and 2010 that manufacturers had not properly assessed the hazardous properties in their SDSs and labels of the pre-mixes. Renewed inspections took place in 2011 at one of these companies, and it was established at that time that this company was complying with the REACH and EU-GHS legislation. Legal proceedings concerning one company are still in progress before the Council of State signals were received of products containing cadmium, and 16 signals of products containing asbestos. Charges were brought in 13 cases (some by Customs), and six measures were taken under administrative law. Arrangements were agreed with a European market leader in additives for the plastics industry to combat the use of lead chromate (a yellow dye found in many plastics) on account of its carcinogenic properties. In response to signals from European enforcement partners, 60,000 flying lanterns were withdrawn from sale at a company in December This prevented 60 km of cord containing asbestos from entering the environment. In addition, ILT inspected nine companies in respect of the import of tyres with a potential excessively high content of polyaromatic hydrocarbons as part of a dedicated Forum project. A European study by the ETRMA industry association that found that 10% of a number of imported Chinese tyre brands infringed Annex XVII was instrumental in ILT requesting the five importers of these tyres in the Netherlands to take measures. All companies responded adequately to this request. ILT also conducted 33 inspections in respect of the PFOS substances15, which initially fell both under Annex XVII and under the POPs Regulation (850/2004/EEC). Following amendment of the legislation on 3 March 2011, they now fall only under the POPs 15 PFOS stands for perfluorooctane sulfonate 2011 Annual Report of Enforcement of REACH and EU-GHS in the Netherlands 07

8 Regulation. The use of foam containing PFOS was prohibited as of 27 June In spring 2011, ILT, the VEBON industry association, and the Ministry of Infrastructure and the Environment organised a symposium to inform as many companies as possible of the ban on extinguishing foam that contains PFOS. Three of the inspections revealed that the extinguishing system had not yet been remediated. Action was taken against these companies under a penal sum procedure. Figure: Number of infringements in each risk category 3.3 Inspections performed by I-SZW among end-users Between 1 September and 31 December 2011, I-SZW conducted inspections among end-users at companies involved in trading and repairing cars. In particular, these inspections were focused on car cleaning companies. The following provisions of REACH legislation were checked: The SDS: This is a pivotal tool under REACH for transferring information about the properties of hazardous substances and about measures to be taken Provision of information to workers about the properties of hazardous substances and the protective measures required Incorporation of information contained in the SDS into health & safety policy, and implementation by the employer of measures to control exposure to hazardous substances Inspection results A total of 85 companies were visited between September and December Most of the visits concerned car cleaning companies under SBI Codes and Equal numbers of companies were and were not members of the FOCWA industry association Infringements A total of 311 infringements were observed at 76 companies (i.e. 89% of the inspected companies were non-compliant). The infringements concerned mostly REACH legislation (71 infringements) and health & safety laws governing hazardous substances (200 infringements)16. The infringements fell into the following categories: 1. SDSs were not up to date and/or failed to satisfy basic requirements. 2. No effective measures had been taken to limit exposure to hazardous substances or to prevent exposure as far as possible. In particular, these infringements concerned: a. Absence of storage facilities and drip trays b. Absence of proper protective equipment such as eye showers c. Incorrect or missing labelling 3. Other infringements concerning working conditions such as 16 The violations with regard to hazardous substances were often connected to REACH obligations such as SDSs (information provision to employees), preventing exposure to hazardous substances, and protective measures. machine safety and workplace safety.17 On average, there were 3.18 infringements per company. FOCWA members performed slightly better than non-members (2.81 against 3.45) Safety Data Sheets Most companies were found to lack up-to-date SDSs, and in those cases where they were present, they were often being used insufficiently. There may be several reasons for this situation: SDSs are provided insufficiently Products used during work are insufficiently recognised as hazardous substances SDSs are too complex and for that reason are read insufficiently It is not possible to pinpoint the main reason in this industry. The SDSs are hardly ever used to inform workers of the risks of hazardous substances. Similarly, the SDSs are not used to prepare or modify workplace health & safety policy or to take appropriate protective measures Measures The inspected companies were unaware that work was taking place with hazardous substances. They did not recognise the risks of the substances. Consequently, the exposure assessment was not carried out, and no protective measures were taken. Many companies do not think they are using hazardous substances. While acknowledging that they use a bit of cleaning agent for the windows, they think it is going too far to regard this as a risk. However, cleaning products are also hazardous substances and may pose risks to users. 17 Although these latter violations were not within the project s focus, they were severe enough for the Inspectors not to ignore Annual Report of Enforcement of REACH and EU-GHS in the Netherlands 08

9 3.4 Inspections performed by SodM SodM has included REACH and EU-GHS compliance in its multi-year project concerning exposure to hazardous substances. This project is based on a programme for strengthening working conditions policy relative to substances (VASt), and is focused on encouraging mining companies to perform a Job Hazard Analysis (RIE) for handling such substances, and taking the measures necessary to mitigate the risks (Plan of Action). As part of this project, the sites, installations or offices of five mining companies were inspected in All of the mining companies stated in the description of their health & safety system that they have arranged or certified their processes in accordance with ISO and OHSAS standards. Two of the five mining companies had not drawn up supplementary Job Hazard Analyses for handling substances under Articles 4.2, 4.2a and 4.13 of the Working Conditions Decree. In most cases, the SDSs were not up-to-date, and many were unavailable in Dutch. The following arrangements were agreed with the companies: Up-to-date SDSs in Dutch will be requested from their suppliers Based on the updated SDSs, the risks will be re-assessed and re-evaluated for the purpose of the Job Hazard Analysis The Job Hazard Analysis will be drawn up or amended, and together with the Plan of Action will be sent within an agreed period of time to SodM for a check on compliance with legislation Following the inspections, various companies launched information campaigns to make their personnel more aware of the implications of the REACH and EU-GHS Regulations. One mining company was visited jointly with an I-SZW inspector with the aim of learning from each other. Given the experience gained during this visit, this cooperation will be continued in The companies concerned will be revisited in 2012 as a result of the agreed arrangements mentioned above Annual Report of Enforcement of REACH and EU-GHS in the Netherlands 09

10 4 Supporting activities StHRG and SHRG The following activities were undertaken with regard to information and communication on enforcement of REACH and EU-GHS: In 2011, StHRG carried out its controlling and coordinating role. SHRG provided supporting activities. Besides internal harmonisation with the policy-making departments of the relevant ministries and the REACH Bureau of the National Institute for Public Health and the Environment (RIVM), SHRG held regular talks with the umbrella organisation VNO-NCW and the most closely involved industry associations (VNCI, VHCP, FME, NRD, and NVZ) about the enforcement of REACH and EU-GHS. A web file tool for enforcement information was continued, including brochures for companies on the general guidance website on substances, Questions related specifically to supervision and enforcement could be submitted by mail. A few dozen questions were answered in I -SZW published a guidance document on how to approach the relationship between workplace health & safety laws and REACH; this document was publicised in the media. 5 European activities At European level, the following activities were carried out in the Forum: P articipation in the Forum of EU Member States for the purpose of exchanging enforcement information. The Forum met on two occasions in A standard part of the conferences was an open session with representatives of European industry associations. A s part of the EU Forum (REACH-EN-FORCE 2), research was conducted into compliance with REACH and CLP among formulators. Those inspected included formulators and distributors of polishes used in the automotive industry. Reporting will take place in P articipation in projects of the Forum s working programme. This included participation in the working party that drew up recommendations regarding enforceability of new substances, substance groups or mixtures (entries) in Annex XVII of REACH (restrictions). The Netherlands also participated in the working party that is overseeing an initial EU enforcement project (REACH-EN-FORCE-1). This project was concluded in In this first joint enforcement project co-ordinated by the Forum, almost 2,400 companies were inspected in EU Member States in respect of their compliance with the REACH Regulation. Infringements were observed at 22% of the inspected companies (in the Netherlands 15%), while at 11% of the inspected companies (in the Netherlands 2%), the SDS was either missing or only partially filled in, and 17% of the SDSs were not in the correct language or lacked the correct contents (in the Netherlands 6% as regards language and 15% as regards contents) Annual Report of Enforcement of REACH and EU-GHS in the Netherlands 10

11 6 Conclusions and recommendations Based on the findings, the following conclusions may be drawn: N VWA and ILT carried out full REACH and EU-GHS inspections at the start and in the middle of the supply chain of chemical substances and preparations (manufacturers, importers, and traders). All inspected companies were familiar with REACH legislation. A majority of the inspected companies had carried out the mandatory registration/preregistration of their substances and preparations. There were infringements of the registration/ preregistration obligation and related matters (intermediates, performance of tests) at 11% of the inspected companies. In 30% of the examined cases, there was not full adherence to the required strictly controlled conditions within the production chain of chemical intermediates. E mployees at almost all fully inspected companies (95%) had access to information about substances and preparations (Article 35 of REACH). At approximately 20% of the inspected companies, the information was not being passed on to parties such as traders and end-users further down the supply chain (Article 34 of REACH). T he mandatory SDSs were available for provision to customers at almost all manufacturers, importers, and traders, and in almost all cases, they were drawn up in accordance with Annex II of REACH. The quality of the SDSs was found to be insufficient at 15% of the inspected companies as regards the information required by law (Section 15: labelling in accordance with EU directives). A lmost all inspected labels (96%) were in the correct language, but at 19% of the inspected companies, the contents of the labelling were not entirely as required. I -SZW has carried out inspections at professional end-users. Downstream in the supply chain (among professional end-users of chemical substances and preparations), the compliance behaviour among the inspected target group (which in 2011 consisted of car cleaning companies) was found to be far worse than among companies at the start and in the middle of the chain (manufacturers, importers, and traders): Approximately 90% of the inspected car cleaning companies infringed REACH legislation and/or workplace health & safety laws concerning hazardous substances. The companies inspected at the end of the supply chain were unaware of the risks of hazardous substances that they were using. They did not recognise the risks, and consequently had not taken any protective measures. Many companies had SDSs for internal use, but these were not up to date. They were not being used to inform employees, amend workplace health & safety policy, or take protective measures. The following recommendations were drawn up to address these findings: D uring supply chain supervision projects in 2012 (chemicals used in the electro and construction industries), it is advisable to find out why there are very probably no up-to-date SDSs at the end of the chain, while at the start and in the middle of the chain, they probably will be present. T he industry association can help companies to translate the complex information contained in the SDSs into readable and workable information. Far- reaching digitisation may be key to this operation. The association can also indicate the protective measures that provide workers with sufficient protection. A digitisation pilot project is already underway in the paint industry, and if successful it can be adopted by other industries. T he compliance behaviour at the inspected companies (manufacturers, importers, and traders) as regards SDSs and labels was found to have improved slightly in 2011 compared with 2008, 2009, and D uring inspections of substances subject to a prohibition, the observed infringements were found to concern mainly products containing cadmium and asbestos. Approximately 10% of the inspected extinguishing systems still used banned foam containing PFOS Annual Report of Enforcement of REACH and EU-GHS in the Netherlands 11

12 Colofon Joint REACH and GHS Enforcement Unit the Netherlands Correspondence address: 18 juli 2012 Inspectorate SZW (I-SZW) Netherlands Food and Consumer Product Safety Authority (NVWA) Human Environment and Transport Inspectorate (ILT) 2011 Annual Report of Enforcement of REACH and EU-GHS in the Netherlands 12