Guideline on the implementation of. European Regulation (EC) 1272/2008

Transcription

1 Avenue Jules Bordet, 142 B-1140 Brussels, Belgium Tel: Fax: eurobat@kelleneurope.com Guideline on the implementation of European Regulation (EC) 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP-GHS-Regulation) for battery production in Europe by the Committee for Environmental Matters (CEM) of EUROBAT Disclaimer: This guideline provides advice on the implementation of the CLP-GHS-Regulation, but does not replace it. Users are reminded that the text of the CLP-GHS Regulation is the only authentic legal reference and that the information in this document does not constitute legal advice. EUROBAT does not accept any liability with regard to the content of this document. EUROBAT, the Association of European Storage Battery Manufacturers, has 36 regular and associate member companies and represents more than 85 % of the battery industry in Europe. It acts as a unified voice and reference source promoting the interests of the European starter and industrial battery industry to consumers, the EU institutions and national governments. Original document: Fachverband Batterien (German Association of Battery Manufacturers) part of ZVEI. Translation into English and revised by Eckhard Fahlbusch (Safety adviser for European chemicals legislation) - CEM Member 1 Approved by CEM May 2011

2 Content 1. Introduction 2. GHS is focussing on a worldwide standardized system 3. The European CLP-GHS-Regulation 4. Implementation of the CLP-GHS-Regulation in companies 4.1 The new hazard pictograms and new hazard classes, categories and statements 4.2 Transitional periods and their implementation 5. Classification of essential battery substances according to hazard class, category, pictograms and statements as well as limit values in the workplace 6. Specific topics for the battery industry 6.1 Permanent wearing of masks when the limit value is exceeded 6.2 Pictograms on Lead batteries up to 01 June 2015 to change in line with the labelling of preparations (henceforth mixtures) 6.3 The production of Lead batteries is not subject to the extended obligations of the Seveso II Directive; 7. Impact on other areas of legislation 8. Impact of the German Technical Rules for Hazardous Substances - TRGS 505 (Lead) 2

3 1. Introduction After more than 40 years the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) is replacing the current European system for the classification and labelling of chemicals. Under GHS, chemicals worldwide shall be classified and labelled according to identical criteria. After the REACH Regulation, the new CLP-GHS-Regulation is the second major change to European Chemicals Legislation within a very short time. This guideline will help EUROBAT members in implementing the essential requirements of the CLP-GHS-Regulation. The goal is to achieve a standardized procedure, especially in order to protect employees during battery production. It also shows the close interaction with other legislative areas like REACH and rules on major-accidents (Seveso Directive) as well as their interaction and impacts on battery production. This guideline can be used for communication with the responsible authorities in the European Member States. The goal will be to contribute to the standardized implementation of the new CLP-GHS Regulation for battery production in Europe. 2. GHS is focussing on a worldwide standardized system Since 2003 the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) has been available at UN level. This system represents the basis for a worldwide standardized system to describe and communicate properties of chemicals. You will find GHS on the website of the UN: During the creation of GHS it was the goal to achieve a worldwide standardized classification and labelling of a substance or mixture. It includes such instruments as a globally applicable catalogue of criteria as well as standardized guidelines for the elements of the communication of hazardous substances. The advantage of such a system is the simplification of crossborder trade while achieving at the same time worldwide standardization and a high level of protection when dealing with substances and mixtures. The battery industry has supported this goal from the beginning. The implementation of GHS is at different stages within countries and regional bodies. The further development of the system at UN level will need further intense discussions regarding the standardization of the established test specifications. Thus, GHS will be implemented at different times in respective national and regional legislation. Some countries and regions have already made timetables available or even taken concrete steps towards its implementation. Current information concerning the status of the worldwide implementation of GHS can be found on the website of the UN, mentioned above. The worldwide standardization of the classification and labelling system will take a while to fully implement. However, GHS has made the first important step in this direction. 3. The European CLP-GHS-Regulation On a recommendation of the EU Commission of 27 July 2007 and after intense discussion in the EU Parliament and the EU Council, the CLP-GHS-Regulation was published on 31 December 2008 (see number (EC) 1272/2008 in the Official Journal of the European Union -> L 353) and came into force on 20 January You will find the text here: 3

4 GHS, as the basis for a worldwide standardized classification and labelling system, has been established. During the development of the CLP-GHS-Regulation through the EU Commission the following principles were in focus: Use of the UN-GHS in order to adopt the system to EU circumstances. Orientation towards procedures of classification and labelling which are as close as possible to the EU system. Maintaining the European category of risks which will be covered by EU legislation but are not yet in the UN system in order to keep the current level of protection in Europe. Ensure consistency with Dangerous Goods Regulations (e.g. ADR). Adoption of annex I (list of substances) of guideline 67/548/EWG. Adoption of the guidelines for classification and labelling list of title XI of the REACH Regulation. Definition of a transitional period in which the current legislation and the new regulation are applicable. Even though the innovations conform to the UN guidelines on GHS, but also need to as closely as possible - align with the current European system, industry needs to be prepared for a variety of changes that will come into effect during the transition. The effort is not insignificant. 4. Implementation of the CLP-GHS-Regulation in companies When implementing the CLP-GHS-Regulation, the first and most important task for the company is similar to the preparation for the REACH Regulation the identification of their own role: Is the company the manufacturer, importer or downstream user of a substance or mixture? If so, it is mandatory irrespective of the quantity concerned to determine the classification before placing it on the market when the criteria are met. If the substance is subject to registration according to REACH, the registering company is obliged to determine the classification, even though the substance will not be placed on the market. 4.1 The new hazard pictograms and new hazard classes, categories and statements One noticeable impact of the regulation concerns the new elements in the communication of dangers. The new pictograms are clearly different in appearance and content to the former pictograms (attachment 1) and show that this is a new system. The criteria of GHS and the current European legislation for determining the physicochemical, toxicological and ecotoxicological properties and end points are not identical in all cases. Concentration limits are changing, the method to classify preparations in future called mixtures is partly following a changed and adopted procedure of the UN-GHS. You will find an overview of the current and new pictograms, new hazard classes, categories and statements in attachment 2 for physical hazards. In the area of acute toxicity some classification criteria for substances have been modified through the CLP-GHS-Regulation. You will find in attachment 3 an aid to assist in the translation of classification under existing legislation to the corresponding classification under the new regulation for health hazards. Attachments 1-3 can be ordered also as posters (Placards CH ) e.g. for use in training, from the following website: 4

5 4.2 Transitional periods and their implementation According to the new European CLP-GHS-Regulation the classification of substances based on the new requirements is mandatory from 1 December 2010 and mixtures from 1 June The current European Hazardous Substances Directive (67/548/EEC) and the Hazardous Preparations Directive (1999/45/EC) will no longer apply from1 June From that date the European CLP-GHS-Regulation will apply exclusively. The deadlines for the operational changeover to GHS are linked to some conditions: Until 1 December 2010 substances will be classified, labelled and packaged according to the European Hazardous Substances Directive (67/548/EEC). The respective classification needs to be stipulated in safety data sheets until June Until 1 June 2015 mixtures will be classified, labelled and packaged according to the Hazardous Preparations Directive (1999/45/EC). By way of derogation, mixtures can be classified, labelled and packaged before the 1 June 2015 according to the requirements of the CLP-GHS-Regulation. In this case the requirements for classification and packaging of the Directive 1999/45/EC do not apply. Substances, already classified according the CLP-GHS-Regulation, in addition have to be classified to the corresponding old European Hazardous Substances Directive (67/548/EEC) until 1 June In this case, both classifications (old and new) have to be included in the safety data sheet. Labelling and packaging must be in accordance with the requirements of the CLP-GHS-Regulation. Substances which have been placed on the market before 1 December 2010 according to the requirements of the Hazardous Substances Directive (67/548/EEC) have a sale period until 1 December This means that, until this date, re-labelling according to CLP- GHS-Regulation is not necessary. For Preparations which have been placed on the market before 1 June 2015 in accordance with the requirements of the Hazardous Preparations Directive (1999/45/EC) have a sale period until 1 June This means that, until this date, re-labelling according to CLP-GHS-Regulation is not necessary. 1 December 2010 is also the key date for the notification for registration in the classification and labelling list according to article 39-42: o Registration before this date is optional. o From 1 December 2010 registration is mandatory and has to be done within one month after placing on the market. There are no limits in relation to volumes concerned. The requirement to register with the European Chemicals Agency (ECHA) according to article 40 of the CLP-GHS-Regulation (until 03 January 2011 at the latest) does not apply to substances which have been already registered under REACH (article 40 (1) sentence 2). 5

6 5. Classification of essential battery ingredients according to hazard class and category as well as pictograms and warnings and workplace exposure limit values After the REACH registration deadline on 1 December 2010 this part will be made available in tabular form after evaluation and in compliance with the REACH registration dossiers and the CLP-GHS-Regulation by the end of June 2011 at the latest Specific topics for the battery industry 6.1 Permanent wearing of masks when the limit value is exceeded. According to 9 (3) of the German Ordinance on Hazardous Substances 2010, the permanent wearing of masks is necessary when, after the implementation of all technical measures, the limit value cannot be met. An exemption from this requirement is not permitted. This is extremely important due to the emerging limit value reduction at the workplace for Lead, Cadmium, Manganese, Nickel, Sulphuric Acid and Zinc. This applies particularly to the proposed values for Sulphuric Acid of 0,05 mg/m³, Nickel of 0,01 mg/m³ and Cadmium of 0,004 mg/m³ as well as the permanent wearing of masks when dealing with Lead as a personal hygiene measure. For a process such as the tank formation of plates to make dry charged batteries, engineering measures (local exhaust ventilation, permanent wetting of floors) are in place to reduce workplace exposures. Despite these controls, exposures to lead and sulphuric acid mist can often exceed limit values and so the permanent use of respiratory protection is required. In this respect it should also be taken into account that the tank formation is state-of-the-art for the manufacture of dry charged batteries. EUROBAT CEM members will check the application of this approach in other relevant Member States to see if it is in compliance with their national legislation. 6.2 Pictograms on Lead batteries up to 01 June 2015 to change in line with the labelling of preparations (henceforth mixtures) The CLP-GHS-Regulation applies to the labelling of substances and mixtures but not to the labelling of articles such as batteries. The labelling of Lead batteries with its 6 pictograms is not a legal requirement but has been practised for many years according to European Standard EN 50342/1. In order to harmonize this labelling with the new pictograms of the CLP-GHS-Regulation, an amendment of the standard and the labelling of Lead batteries will be made by 1 June 2010 similar to the labelling of mixtures. 6.3 The production of Lead batteries is not subject to the extended obligations of the Seveso II Directive; In the context of a legally hazardous substance classification of active substances in batteries during REACH registration and the implementation of the CLP-GHS-Regulation up to 1 December 2010, it is necessary to have a re-evaluation of the application of areas of the extended obligations of the Seveso Directive also in order to guarantee the necessary legal certainty for companies. Thus, the EU Commission has initiated a further revision of the Seveso II Directive. An important aspect of the revision is the adaptation of the Seveso II Directive to the CLP-GHS- Regulation. The new classification of substances through the CLP-GHS-Regulation is especially relevant for the revision of Annex I of the Seveso II Directive which contains the

7 substance name and classification of substances incl. the volume threshold which defines the application area of the Seveso II Directive. An extension of the application on the chronic effects of substances (so called classification as STOT RE Specific Target Organ Toxicity - Repeated Exposure (H372)) shall not occur according to the submitted draft of the Seveso II Directive, as the major-accident legislation is focussed on the acute danger. With this, also inorganic Lead compounds like Lead Oxide would not be affected by the extended obligations according to the classification (STOT RE1 (H372)) in the context of the REACH Registration. Under REACH only pure substances or pure substances that are present in preparations or mixtures have to be registered. This means that Battery Lead Oxide, which is classified as a preparation or mixture of lead metal and lead oxide by the battery industry, does not have to be registered and is not newly classified. Thus, the Hydrotox results R52/53 (harmful to water organisms) for the mixtures Battery Lead Oxide and Lead Battery Paste can continue to be used. Not excluded - medium-term - can be new evaluation methods according the CLP-GHS-Regulation. Lead Metal has been evaluated according to the OECD Transformation Dissolution Test on behalf of the Lead REACH Consortium. The test results have shown that Lead Metal in a massive form (Lead in ingots) can be excluded from a major-accident classification. The result of the evaluation is an equivalent classification of Lead Metal as R52/53 which is not Seveso relevant. The non-application in 2006 of the expensive and costly extended obligations in the European major-accident legislation, which was achieved in co-operation with the authorities, will be maintained. 7. Impact on other legislation areas The classification criteria of the previous Hazardous Substance Directive (67/548/EEC) and the Hazardous Preparations Directive (1999/45/EC) as well as the current CLP-GHS- Regulation have direct or indirect impact on a variety of European and national rules. When changing the system there will be a need for considerable adjustments in other legal areas. The breadth of impact ranges from the simple acceptance of the new system up to the amendment of legislative texts. Therefrom, rules will be derived which will influence the handling or marketing of products. This includes the legislation for safety at work, protection of minors and mothers, waste, major-accidents, emissions, water pollution and storage. Also restrictions or bans can occur with marketing such as the self-imposed ban for determined chemicals in the retail sector. The European Commission has identified approximately 20 European directives and regulations which needed to be amended accordingly. In some cases this can be made by simple amendments (formal adoption) e.g. the Battery, ELV and RoHS Directives. For a number of EU rules a simple formal adoption will not be possible. This includes the list of wastes and hazardous wastes as well as the Seveso II Directive (see also number 6.3 of this guideline). Also an adaptation of the legislation will be necessary at national level especially in regards to the national chemicals legislation. The EUROBAT secretariat and the members of the EUROBAT Committee for Environmental Matters will monitor this implementation procedure Impact of the German Technical Rules for Hazardous Substances - TRGS 505 (Lead) The German Committee for Hazardous Substances (AGS) will in future evaluate the Technical Rules for Hazardous Substances (TRGS) that will be necessary in practice and will review these accordingly. The requirements imposed by the German Ordinance on Hazardous Substances will be met when the respective TRGS are in compliance with it.

8 This is especially relevant for the TRGS which contains protective measures e.g. TRGS 505 (Lead). The TRGS 505 (attachments 4 and 5) was adopted by consensus by social partners, scientists and competent authorities in Germany. For this reason the implementation of TRGS 505 could be an appropriate approach for Lead battery production in other relevant EU Member States by agreement between the battery manufacturers and the responsible authorities. The protection of employees was addressed through the application of section 5 of the TRGS 505 and through this process the Biological Limit Value of 40 µg Pb/dl blood was achieved without an Occupational Exposure Level. This could be a suitable solution for handling Cadmium and its compounds during the production and recycling of NiCd Batteries in Germany and other relevant EU Member States. A Technical Rule for Cadmium is being prepared by the German Committee for Hazardous Substances. 8