CEPE GUIDE TO LABELLING and PACKAGING of DANGEROUS PREPARATIONS for the Paint, Varnish, Printing Ink and Artists’ Colours Industry 11th Edition Part 1 General Guidance on Packaging and Labelling requirements of the Dangerous Preparations Directive 1999/45/EC and Annex XVII to REACH Regulation (EC) N° 1907/2006 (formerly Marketing and Use Directive 76/769/EEC) Date of issue: 2009-06-10 (Revised 2009-08-26) Replaces 10th Edition dated: 2007-03-28 The 11th edition was prepared by the members of the CEPE Technical Committee ‘Labelling and Safety Data Sheet’. This guide is based on the best knowledge of the CEPE Technical Committee ‘Labelling and Safety Data Sheets’. No liability can be accepted for any errors or omissions. The final responsibility for correct classification, packaging and labelling rests with the user of this Guide. CEPE Labelling Guide 11th edition – Part 1 1 This guide consists of 3 parts: Part 1: General Guidance on Packaging and Labelling requirements of the Dangerous Preparations Directive 1999/45/EC and Annex XVII to REACH Regulation (EC) N° 1907/2006 (formerly Marketing and Use Directive 76/769/EEC) Part 2: Labelling requirements arising from other legislation and voluntary labelling Part 3: Catalogue of translations of P-phrases Document1 CEPE Labelling Guide 11th edition – Part 1 2 Part 1 INDEX Table of changes 4 1. Introduction 5 2. Legal background 2.1 Basic Legislation 2.2 Other Directives/Regulations governing the packaging and labelling of dangerous preparations 2.3 Effects on other directives 2.4 References 7 7 7 8 8 3. Requirements to label 3.1 General 3.1.1 Which preparations are covered by the DPD? 3.1.2 Classification as dangerous 3.1.3 Labelling as dangerous for supply 3.2 Content and size of label 3.2.1 Language 3.2.2 General requirements 3.2.3 Label dimension and design 3.2.4 Transport and supply labels 3.3 Rules for Symbols, phrases and names 3.3.1 Symbols 3.3.2 R-, S- and P-Phrases 3.3.3 Chemical Names 11 11 11 11 12 12 12 12 13 14 15 15 15 17 4. Special labelling requirements arising from the DPD 4.1 Non Hazardous Preparations 4.2 Rules/Exemptions for small packaging 4.2.1 Packaging not exceeding 125 ml 4.2.2 Packaging too small or otherwise unsuitable for the required labelling 4.3 Two packs products 4.4 Aerosols 4.5 Special R-phrases requirements 4.5.1 Aspiration hazard 4.5.2 Isocyanates 4.5.3 Skin dryness or cracking - R66 4.5.4 Drowsiness and dizziness - R67 4.5.5 Preparations containing a substance assigned R33 4.5.6 Preparations containing a substance assigned R64 19 19 19 19 Special packaging requirements 5.1 General 5.2 Specific rules 5.2.1 Child resistant fastenings 5.2.2 Tactile warnings of danger 5.2.3 Preparations not classified as sensitising but containing at least one sensitising substance 5.2.4 Preparations containing halogenated hydrocarbons 24 24 24 24 25 5. 19 20 20 20 20 21 21 22 23 23 26 26 Document1 CEPE Labelling Guide 11th edition – Part 1 3 Appendices 1.1. Selection of S-Phrases 27 1.2. Selection of P-phrases 31 1.3. Regulations, Directives, Amendments and Adaptations relevant to this Guide 35 Document1 CEPE Labelling Guide 11th edition – Part 1 4 TABLE OF CHANGES Changes introduced to the 10th edition – 2007-03-28 ADDITIONS Chapter 2 references to REACH and CLP Regulations Par. 2.1 Note on repeal date of DSD and DPD Par. 2.2 Par. 2.4 Appendix 1.2 Chapter 1 Chapter 2 Reference to the last amendment of the Aerosol directive New references to the REACH and CLP Regulations and to Directive on Land Transport of Dangerous Goods Additional note related to REACH Regulation (EC) No 1907/2006 Reference to the CLP Regulation New P-phrases for DEGBE, MDI and DCM AMENDMENTS Reference to Annex I DSD replaced by CLP Regulation (EC) No 1272/2008, Annex VI, Part 3, Table 3.2 Reference to Annex I DSD replaced by CLP Regulation (EC) No 1272/2008, Annex VI, Part 3, Table 3.2 References to MUD 76/769/EEC replaced by Annex XVII to REACH Regulation Par. 3.1; 3.3.3, Reference to Annex I DSD replaced by CLP Regulation (EC) No 4.5.2, 4.5.6 1272/2008, Annex VI, Part 3, Table 3.2 and 5.2.3 Appendix 1.2 renumbering of indents 1.5 to 1.10 due to deletion of 1.4 Appendix 1.3 Chapter 1 Par. 2.4 Par. 3.2.2.6 Par. 3.3.2.4 and Appendix 1.2, 1.4 adaptations of references to actual legislation WITHDRAWN/DELETED Reference to MUD References to BPD, VOC Product Directive and detergent Regulation taken out as mentioned in section 2.2 Editorial changes in the before last paragraph Several references to amendments of DSD Reference to MUD 76/769/EEC References to ADR and DIR Directives Reference of the ranges set earlier in Directive 80/232/EEC P93 is deleted Document1 CEPE Labelling Guide 11th edition – Part 1 1. 5 INTRODUCTION This guide deals only with the classification, packaging and labelling rules governing supply of dangerous preparations. Separate rules apply to the transport of dangerous preparations. This guide considers the European Union harmonised legislation relating to the classification, packaging and labelling of preparations (mixtures). This legislation is detailed in chapter 2 ‘Legal Background’. The CEPE guide to labelling and packaging of dangerous preparations deals only with the aspects related to paints, printing inks and artists’ colours and related products. For the classification of these preparations, the CEPE Members should refer to commercial available software or other methods. This guide has been prepared by the CEPE Technical Committee ‘Labelling and Safety Data Sheets’ with the aims of: helping the CEPE Members classify and produce labels in accordance with the DPD 1999/45/EC and other directives when required avoiding discrepancies in the labelling of products with a similar hazard classification. Including industry voluntary phrases to address issues such as duty of care, product stewardship, etc. This guide gives the basic principles of the classification, packaging and labelling of preparation enabling the selection of the proper instructions for commercially available labelling software. It should be noted that, in some cases, other obligations than those arising from the DPD – (see section 2.2) – can force the supplier of a preparation to provide more information than those derived from the DPD. Labels constitute a first way to inform the user of a preparation of the intrinsic hazard and potential risk arising from its properties. The CEPE Technical Committee “Labelling and Safety Data Sheet” reiterates the provisions of Annex II to the REACH Regulation (EC) No 1907/2006 on the Safety Data Sheets, which is the way to inform in detail the professional user exposed to the preparation. This guide is based on the best knowledge of the CEPE Technical Committee ‘Labelling and Safety Data Sheets’. No liability can be accepted for any errors or omissions. The final responsibility for correct classification, packaging and labelling rests with the user of this Guide. In this guide, - ‘Coatings’ means paints, printing inks, varnishes and artists’ colours. - ‘Preparations’ are mixtures or solutions composed of two or more substances. Document1 CEPE Labelling Guide 11th edition – Part 1 - 6 ‘Substances’ means chemical elements and their compounds in the natural state or obtained by any production process, including the additive necessary to preserve the stability of the product, and impurity deriving from the production process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. Where impurities, additives or individual constituents of substances have been identified, they shall be taken into consideration if their concentration is greater or equal to the limits specified in Annex VI, 1.7.2.1 to the DSD. Substances not already listed in the CLP Regulation (EC) No 1272/2008, Annex VI, Part 3, Table 3.2 have to be self-classified by the supplier according to the rules of DSD. The rules for the classification, packaging and labelling of preparations are similar to those applied for substances. The symbols, risk phrases and safety phrases applied to substances and preparations are given in the Annex VI to DSD. The following abbreviations are used in this document ATP: Adaptation to the Technical Progress CLP: Classification, Labelling and Packaging of Substances and Mixtures (Regulation (EC) No. 1272/2008) CRF: Child Resistant Fastenings DPD: Dangerous Preparations Directive DSD: Dangerous Substances Directive EEA: European Economic Area (EU+NO+IS+LI) EC: European Communities EU: European Union FP: Flash Point GP: General Public MS: Member States MW: Molecular Weight OEL: Occupational Exposure Limit REACH: Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals SDS: Safety Data Sheet TWD: Tactile Warning of Danger In this document, no account it is taken of the DPD provisions related to gaseous preparations, explosives, alloys and polymers in massive forms, nor of the provisions for plant protection products covered by Directive 91/414/EEC, which are all irrelevant to paints, printing inks and artist’s colours. The provisions relating to the danger for the ozone layer are not referred in this document as such substances are not known to be used in the manufacture of paints, printing inks and artists’ colours. Document1 CEPE Labelling Guide 11th edition – Part 1 2. 7 LEGAL BACKGROUND This guide describes the state of the art for the legislation mentioned in sections 2.1, 2.2, 2.3 and 2.4. For the status of the various amendments and adaptations of the directives mentioned in this section of the Guide, the reader should refer to Appendix 3. 2.1 Basic Legislation The classification and labelling of preparations is primarily governed by Council Directive, 67/548/EEC and adaptations and amendments, on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous substances (referred to in this guide as the “DSD”). This directive includes a Labelling Guide (Annex VI), which sets out the rules for the classification and labelling of substances and preparations. Annex I to this Directive (list of classified dangerous substances) is deleted since 20 January 2009 and replaced by Annex VI, Part 3, Table 3.2 of CLP. Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations and its adaptation to the technical progress and amendment (the “DPD”). Note: both Directives will be repealed by 1 June 2015. 2.2 Other Directives/Regulations governing the packaging and labelling of dangerous preparations Council Directive, 75/324/EEC, on the approximation of the laws of the Member States relating to aerosols dispensers (adapted by Directive 94/1/EC and 2008/47/EC) concerning special labelling provisions for preparations placed on the market in the form in aerosols dispensers (the “Aerosol Directive”). European Parliament and Council Directive 98/8/EC concerning the placing of biocidal products on the market (the “BPD”) European Parliament and Council Directive 2004/42/EC (The “VOC Product Directive”) concerning the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC. Regulation (EC) No 648/2004 of the European Parliament and the Council on Detergents (the “Detergents Regulation”) Regulation (EC) No 1907/2006 of the European Parliament and the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and in particular its Annex XVII relating to restrictions on the marketing and use of certain dangerous substances and preparations (formerly the “Marketing and Use Directive 76769/EEC repealed on 1 June 2009”) Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods Document1 CEPE Labelling Guide 11th edition – Part 1 2.3 8 Regulation (EC) No 1272/2008 of the European Parliament and the Council concerning of 16 December 2008 on the Classification, Labelling and Packaging of substances and mixtures Effects on other directives The classification and labelling of dangerous preparations have to be taken into consideration for the provisions set in other directives such as: • Council Directive, 88/378/EEC, on the safety of toys (the “Toys Safety Directive”) • Council Directive, 91/689/EEC, on hazardous waste (the “Hazardous Waste Directive”) to be repealed on by Directive 2008/98/EC of the European Parliament and the Council of 19 November 2008 on waste and repealing certain Directives on 12 December 2010 (this Directive modifies few article of Directive 91/689/EEC). • Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) • Council Directive, 96/82/EC, on the control of major-accident hazards involving dangerous substances (the “COMAH Directive”) • Annex II to the REACH Regulation (EC) No 1907/2006 on the Safety Data Sheets repealing by June 1st, 2007 Commission Directive, 91/155/EEC. 2.4 References 67/548/EEC, Dangerous Substances Directive (DSD) The 28th Adaptation to the Technical Progress (Directive 2001/59/EC of 6 August 2001, OJ L 225 of 21.8.2001) adapts especially Annex VI dealing with the labelling guide. To Note: Annex I to this Directive (list of classified dangerous substances) is deleted since 20 January 2009 and replaced by Annex VI, Part 3, Table 3.2 of CLP Directives 2008/58/EC (30th adaptation) and 2009/2/EC (31st adaptation) dealing with the adaptation of Annex I due to be implemented by 1 June 2009 will not be transposed by Member States but be subject to the 1st ATP to CLP Document1 CEPE Labelling Guide 11th edition – Part 1 9 75/324/EEC, Aerosol Directive 20 May 1975, OJ L 147 of 9. 6. 75 adapted by Directive 94/1/EC of 6 January 1994, OJ L 23 of 28. 1. 94 and last amended by Directive 2008/47/EC of 8 April 2008, OJ L 96 of 9. 4. 2008 76/211/EEC, Nominal quantities on the packages 20 January 1976, OJ L 46 of 21. 2. 76 amended by Directive 2007/45/EC of 5 September 2007, OJ L 247 of 21. 9. 2007 80/232/EEC, Ranges of Nominal Quantities for General Public 15 January 1980, OJ L 51 of 25. 2 80 repealed on 11 April 2009 by Directive 2007/45/EC 88/378/EEC, Safety of Toys Directive 7 June 1988, OJ L 187 of 16. 7. 88 89/391/EEC, Safety at Work Directive 12 June 1989, OJ L 138 of 29. 6. 89 91/689/EEC, Hazardous Waste Directive 12 December 1991, OJ L 377 of 31. 12. 91. to be repealed on by Directive 2008/98/EC of the European Parliament and the Council of 19 November 2008on waste and repealing certain Directives on 12 December 2010 (this Directive modifies few article of Directive 91/689/EEC). 96/82/EC, COMAH Directive 9 December 1996, OJ L 10 of 14. 1. 97 amended by Directive 2003/105/EC of 16 December 2003, OJ L 345 of 31. 12. 2003. 98/8/EC, Biocidal Products Directive 16 February 1998, OJ L 123 of 24. 4. 98 98/24/EC, Chemical Agents Directive 7 April 1998, (14th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC), OJ L 131 of 5 5. 98, last amended by Directive 2007/30/EC of 20 June 2007, OJ L 165 of 27. 6. 2007 1999/45/EC, DPD European Parliament and Council Directive concerning the approximations of the laws, regulations and administrative provisions of the Member States Document1 CEPE Labelling Guide 11th edition – Part 1 10 relating to the classification, packaging and labelling of dangerous preparations of 31 May 1999, OJ L 200, 30.7.1999 Adapted to the technical progress and amended by Directive 2001/60/EC of 7 August 2001, OJ L 226, 22.8.2001 Directive 2006/8/EC of 23 January 2006 amending Annexes II, III, and V …, OJ L 19, 24.1.2006 2004/42/EC, VOC Product Directive European Parliament and Council Directive concerning the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC of 21 April 2004, OJ L143, 30.4.2004 Regulation (EC) No 1907/2006, (the “REACH Regulation”) Regulation of the European Parliament and the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing […] Commission Directive 91/155/EEC, […], OJ L 396 of 30. 12. 2006 (The Annex II on the Safety Data Sheets repeals Commission Directive, 91/155/EEC on June 1st, 2007 and the Annex XVII on restrictions of marketing and uses, repeals Directive 76/769/EEC on June 1st, 2009). Regulation (EC) No. 1272/2008 (the “CLP Regulation”) Regulation of the European Parliament and the Council of 16 December 2008 on the 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, OJ L353 of 31. 12. 2008 (This Regulation delete Annex I to Directive 67/548/EEC on 1 June 2009) Document1 CEPE Labelling Guide 11th edition – Part 1 3. REQUIREMENTS TO LABEL 3.1 General 11 3.1.1 Which preparations are covered by the DPD? A preparation must be evaluated to determine if it is classified as dangerous for supply if: - it contains at least one dangerous substance (listed in Annex VI, Part 3, Table 3.2 of CLP) or - it contains at least one dangerous substance self-classified by the supplier in accordance with DSD, or - it is described by one of the categories in Annex V of the DPD. 3.1.2 Classification as dangerous A preparation is classified as dangerous when: - it has a physical-chemical hazard when determined in accordance with the tests of Annex V of DSD1 and/or it has a health hazard when determined by calculation (the “conventional method”) or by testing in accordance with the tests of Annex V of DSD Note: this conventional method does not apply for the aspiration hazard where viscosity has also to be taken into account (see 4.5.1). - it has an environmental hazard when determined by calculation (the conventional method, including M-factors; Annex III to the DPD) or by testing in accordance with the tests of Annex V of the DSD. Note: when a preparation contains one or more mixtures of substances or complex substances (e.g. substances listed in Annex VI, Part 3, Table 3.2 of CLP under Index No. 648 or 649), the constituents mentioned in Chapter 3 of the SDS should be taken into consideration individually when calculating the classification of the product. For the remaining part of the composition, the classification of the complex substance given by the supplier should be taken into consideration with the exception of the carcinogenic classification (R 40) assigned to specific mentioned components in chapter 3 of the SDS. (For carcinogenicity the corresponding Notas in Annex VI, Part 1 to CLP applies). Note on the classification for the danger to the aquatic environment: For preparations containing substance(s) classified R50 or R50/53 in Annex VI, Part 3, Table 3.2 of CLP affected with specific concentration limits, those concentration limits apply. When the preparation contains substance(s) classified R50 or R50/53 appearing in Annex VI, Part 3, Table 3.2 of CLP without specific concentration limits or is selfclassified by the manufacturer, the concentration limits shall be assigned in accordance with the specifications in Part B of Annex III of DPD (as amended by Directive 2006/8/EC –i.e. M-factors applied). 1 Physico-chemical testing need not be done if none of the substances present has such a hazard. Document1 CEPE Labelling Guide 11th edition – Part 1 12 3.1.3 Labelling as dangerous for supply The package of a preparation classified as dangerous is required to carry a label containing specified information. This information relates to the supply of the preparation and provides an overview of the key health, environmental and safety issues related to the preparation. Application of the classification procedures in the DPD leads to the classification of the preparation in one or more categories of danger, each with its associated hazard symbol and qualifying R- and/or S-phrases. However not all symbols and R- and S-phrases need necessarily be shown on the label. The DPD sets out rules for selection of the various requirements for the label. These are dealt with in the following sections of the Guide. 3.2 Content and size of label 3.2.1 Language The languages to be used for the labelling of preparations are the official language(s) of the country on which they are placed on the market. Note: In Belgium, labelling in Dutch, French and German is compulsory. In Switzerland one of the three national languages, German, French, Italian is acceptable 3.2.2 General requirements The following information shall be clearly and indelibly marked on any package: 3.2.2.1 Trade name The trade name or designation of the preparation. 3.2.2.2 Name - address - telephone number The name and full address including the telephone number2 of the person established in the Community, who is responsible for placing the preparation on the market, whether it be the manufacturer, the importer or the distributor. 3.2.2.3 See 3.3.3 Chemical names 3.2.2.4 Symbols See 3.3.1. When symbols are required, those may express a health hazard and/or an environmental hazard and/or physical-chemical hazard. 2 It is recommended to include the international telephone access code Document1 CEPE Labelling Guide 11th edition – Part 1 3.2.2.5 See 3.3.2. 13 Warning phrases The appropriate combination of hazard (R) and safety (S) phrases must be shown. It is not required to indicate code and number of the phrases on the label, only the full text. In addition, phrases from DSD, from Annex V of DPD and from the Marketing and Use Directive must be shown, if applicable. These phrases have been assigned ‘P’ numbers by CEPE for ease of reference. Other phrases that have been agreed at an industry level, including additional S-phrases, may be included on a voluntary basis. 3.2.2.6 Nominal quantity For any preparation sold to the general public, the nominal quantity (expressed either as mass or volume) shall be shown according to Directive 76/211/EEC. 3.2.3 Label dimensions and design 3.2.3.1 Generally the information shall be shown within an area defined by size and clear outline. The area can take the form of a label, which must then be firmly affixed to one or more surfaces of the primary packaging, so that the information can be read horizontally when the packaging is set down normally. Foldout labels firmly affixed by one face to the package may be used. 3.2.3.2 The colour and presentation of the label, or the packaging (if the required information is printed directly onto the packaging), shall be such that the danger symbol(s) and its background stand out clearly (see 3.3.1). 3.2.3.3The dimensions of the information area or label shall be as follows: Package contents Dimensions Dimension symbol -less than or equal to 3 litres -greater than 3 litres and not exceeding 50 litres -greater than 50 litres and not exceeding 500 litres -greater than 500 litres at least 52 x 74 mm (if possible) at least 19,6 x 19,6 mm at least 74 x 105 mm at least 27,9 x 27,9 mm at least 105 x 148 mm at least 148 x 210 mm at least 39,4 x 39,4 mm at least 55,7 x 55,7 mm To note: each symbol must cover at least 1/10 of the surface area of the label but shall not be less than 1 cm². Document1 CEPE Labelling Guide 11th edition – Part 1 14 3.2.4 Transport and supply labels 3.2.4.1 For the purposes of the DPD, labelling requirements shall be deemed to be satisfied in the following two cases: an outer packaging, containing one or more inner packaging is labelled in accordance with the international regulations on the transport of dangerous preparations, and if the inner packaging or packaging is labelled in accordance with the DPD; a single packaging if labelled in accordance with the international regulations on the transport of dangerous preparations and if, furthermore, the label shows the name, address and telephone number of the manufacturer or other person placing the preparation on the market, the names of constituents and the warning phrases (i.e. if the packaging needs to be labelled in accordance with transport regulations, in order to avoid duplication, the DPD allows the omission of corresponding symbols normally required by the Directive). Document1 CEPE Labelling Guide 11th edition – Part 1 3.3 15 Rules for symbols, phrases and names 3.3.1 Symbols 3.3.1.1 Each symbol shall cover at least one tenth of the surface area of the label and shall not be smaller than 1 cm² even for very small packaging. The orange-yellowish background must stand out clearly on the label and the symbol must be black. 3.3.1.2 Symbols must always be accompanied by the related indication of danger. Every time that this Guide mentions “symbol”, it means “symbol + indication of danger”. 3.3.1.3 The precedence for use of symbols is as follows: - for physical-chemical hazards: E overrides 0 ,F+ and F - for health hazards: T+ overrides T overrides C overrides Xn overrides Xi. 3.3.2 R-, S- and P-phrases 3.3.2.1 General The following general information is applicable: - a maximum of six R-phrases and six S-phrases is generally considered as sufficient by the DPD. This number may be reduced, but all principal hazards must be covered by the phrases. Some phrases are however mandatory. Combination phrases of the form -/-/- are regarded as single phrases. - in addition to the R-phrases and S-phrases, relevant Pphrases might be required. 3.3.2.2 R-phrases R-phrases (which give information related to the hazard(s) associated with a specific substance or preparation) are listed in Annex III of DSD. Combinations of R phrases can also be used. The following specific rules are applicable to R phrases: - R11 (highly flammable) and R12 (extremely flammable) need not appear if they would repeat an indication of danger already used in combination with the symbol F or F+. - within the group of R-phrases describing the acute toxicity hazard (R20 to R28), overriding may be done but should be limited to the same route of exposure. Document1 CEPE Labelling Guide 11th edition – Part 1 16 Thus: R26 overrides R23, R23 overrides R20 (inhalation) R27 overrides R24, R24 overrides R21 (absorption through skin) R28 overrides R25, R25 overrides R22 (ingestion) - within the group of R-phrases describing the corrosivity/irritation hazard, the following rules are applicable: R34 overrides R36 and R38 and combinations R34 overrides R41 R35 overrides R34 The same applies if one of the above R phrases is part of a combined R phrase. - In cases where preparations are classified with R45, 46, 49, 60 and/or 61 and also as very toxic, toxic or harmful, the R-phrases R20 to 28 and R39; 40, 48 65 and 68, and all combinations of these R-phrases shall be preceded by the word ‘also’. - when phrases originating from a component do not correspond to the degree of danger of the preparation due to its concentration, less severe phrases must be chosen (declassification rule). For example: If a preparation is classified Xn, due to a T component with R23, 24 and/or 25, these phrases must be replaced respectively by R20, 21 and/or 22. 3.3.2.3 S-phrases S-phrases (which give advice on the safe storage, handling, use or disposal of substances or preparations) are listed in Annex IV of the DSD. Official combinations of S-phrases can also be used. Appendix 1 gives guidance on the selection of S-phrases, based on the R-phrases assigned to the preparation. 3.3.2.4 P-phrases P-phrases are unofficial CEPE reference numbers. The CEPE TC LSDS have allocated these to phrases other than R-phrases or S-phrases, which either are required by DPD and other directives or have been prepared by industry. They give supplementary or specific advice on particular health, safety or environmental topics. P-phrases relevant to the coatings industry are listed in Appendix 1.2. Their translations in all the EU and EEA languages are in Part 3. Document1 CEPE Labelling Guide 11th edition – Part 1 17 P-phrases apply for preparations corresponding to the following cases: P90: Lead compounds P91: Isocyanates P92: Epoxy compounds of low molecular weight P94: Disposal of emptied containers (apply for T+, T, C preparations) P95: Restricted for professional use P96: Aerosols (general) P97: Aerosols (flammable) P99: Preparations not classified as sensitising but containing at least one sensitising substance P100: Liquid preparations containing chlorinated solvent above 0.1% P101: Preparations not classified but containing at least one dangerous substance or a substance having an occupational exposure limit. 3.3.3 Chemical names 3.3.3.1 A substance must be named according to the designation listed in Annex VI, Part 3, Table 3.2 of CLP or by an internationally recognised designation, if it is not yet listed in Annex I (selfclassification). 3.3.3.2 As a general rule, a maximum of four chemical names shall suffice to identify the substances primarily responsible for the major health hazards, which have given rise to the classification and to the choice of the corresponding phrases referring to the hazards involved. In some cases, more than four chemical names may be necessary: - for preparations classified T+, T or Xn, only the substances T+, T, C or Xn present in concentrations equal to, or greater than the lowest limit (limit Xn or Xi) as mentioned in Annex VI, Part 3, Table 3.2 of CLP or otherwise as mentioned in part B of Annex II to the DPD have to be taken into consideration. - the name of the substances which have given rise to the classification of the preparation in one or more of the following categories: - carcinogen category 1, 2 or 3 - mutagen category 1, 2 or 3 - toxic for reproduction category 1, 2 or 3 - very toxic, toxic or harmful due to non-lethal effects after a single exposure (R39, …) Document1 CEPE Labelling Guide 11th edition – Part 1 - 18 toxic or harmful due to severe effects after repeated or prolonged exposure (R48) sensitising Substances classified as - explosive - oxidising - extremely flammable - highly flammable - flammable - irritant - dangerous for the environment need not to be mentioned on the label unless the substance has to be mentioned pursuant to the previous categories. 3.3.3.3 Where a manufacturer can demonstrate that the disclosure of the chemical identity of a harmful or irritant (with the exception of R 41 substances) substance, will put at risk the confidential nature of the preparation, he is allowed to refer to that substance by means of a name that identifies the most important functional chemical groups or by means of an alternative name (guidance for generic names can be found in Annex VI of the DPD). Where this is the case, the manufacturer must inform the authorities of the Member State in which the product is first placed on the market. This request must be made in accordance with the provisions of Annex VI, part A, of the DPD. Document1 CEPE Labelling Guide 11th edition – Part 1 19 4. SPECIAL LABELLING REQUIREMENTS ARISING FROM THE DPD 4.1 Non hazardous preparations The label of preparations intended for professional users and not classified as dangerous but containing at least one substance, in an individual concentration of 1 % or more by weight, posing health or environmental hazards or for which there is a Community workplace exposure limit must bear the following inscription: “Safety data sheet available for professional user on request”. (See also P 101 in Appendix 1.2.1.10). Preparations not classified as dangerous but containing one dangerous substance must fulfil the packaging requirements mentioned in 5.1.1 to 5.1.5. For any preparation not classified as dangerous, phrases that have been agreed at an industry level, including S-phrases, may be included in the label on a voluntary basis. 4.2 Rules/Exemptions for small packaging 4.2.1 Packaging not exceeding 125 ml For preparations classified as F, O, Xi (except with R 41) or N, R- and S-phrases need not be indicated. Only the symbol has to be indicated. For preparations classified as Flammable (R10, no symbol), or dangerous for the environment without N, the R- phrases have to be indicated, but not the S-phrases. 4.2.2 Packaging too small or otherwise unsuitable for the required labelling Packaging of any preparations classified as dangerous may be unlabelled or labelled in some other way, if they contain such a small quantity that they do not represent a danger. Note that for this section authorisation has to be provided by the national authorities. Where this derogation is applied, the use of symbols, R- and Sphrases different to those laid down in the DPD is not permitted. Document1 CEPE Labelling Guide 11th edition – Part 1 4.3 20 Two pack products Label each container according to its own danger and give the dangerous characteristics of the mixture in the safety data sheet. Where the base container is supplied part-filled, so as to allow the activator to be mixed with the base in the container, the container should be labelled “See information supplied by the manufacturer”. See also Appendix 1.2, par. 1.2 (P91) and par.1.3 (P92) for obligatory label phrases for isocyanate and low molecular weight epoxy compounds. 4.4 Aerosols Labelling of DPD applies to the whole content of the aerosol dispenser. Aerosol dispensers whatever they contain must bear the P96. Where the content is flammable according to the criteria laid down in DSD, the container is labelled with the symbol "extremely flammable", "highly flammable" or "flammable" and P97. 4.5 Special R-phrases requirements 4.5.1 Aspiration hazard Preparations meeting the criteria below are required to be labelled with the symbol Xn and the R65: “Harmful: may cause lung damage if swallowed” Criteria: - contains 10% or more of aliphatic, alicyclic and/or aromatic hydrocarbons and - has a flow time of less than 30 seconds, in a 3 mm ISO cup according to ISO 2431 at 23°C or - has a kinematic viscosity of less than 7x10-6 m2.s-1 at 40°C in accordance with ISO 3104/3105 or - has a kinematic viscosity derived from measurements of rotational viscometry in accordance with ISO 3129 of less than 7x10-6 m2.s-1 at 40°C - or based on practical experience in humans. R65 does not apply to preparations meeting the above criteria, but which have a surface tension greater than 33 mN.m-1 at 25°C as Document1 CEPE Labelling Guide 11th edition – Part 1 21 measured by the Nouy tensiometer or by the test methods shown in Annex V, part A.5 to DSD. R65 does not apply to preparations supplied in an aerosol container or in a container with a sealed spray attachment. 4.5.2 Isocyanates Preparations containing 1% or more of any isocyanate compounds unless a lower limit is set in Annex VI, Part 3, Table 3.2 of CLP should be classified as an inhalation sensitiser and should be labelled “Xn; R42” In addition, preparations containing 1% or more of oligomeric or prepolymeric isocyanates based on HDI3 should also be classified as a skin sensitiser and should be labelled “Xn; R42/43” Skin dryness or cracking – R66 Exclusions R66 is not required for preparations that are classified and labelled Xi, R38. This section of the guide should be ignored for such preparations and additionally for any preparation classified and labelled R24 or R27. R66 can only be assigned to preparations that are already classified for another physico-chemical, health or environmental effect. 4.5.3 Assigning R66 to coatings For coatings, it is possible that substances in the following raw material categories might be assigned R66: inorganic/organic solids and organic liquids: Inorganic and organic solids; any solid substance, assigned R66 need not be taken into consideration, unless there is practical observation after normal handling and use or relevant evidence of skin dryness or cracking from contact with the coating, which is specifically due to the substance in question. Any solid substance, for which there is no practical experience of use in the coatings industry and which is assigned R66, should be taken into account. 3 See SHEOP Status Report No 1 of 1997-10-21, latest updated in May 2004, available on the Extranet Document1 CEPE Labelling Guide 11th edition – Part 1 22 Organic liquids; all organic liquid substances, which are assigned R66 and S24, should be taken into account. Preparations meeting the criterion below are assigned the risk phrase R66 (Repeated exposure may cause skin dryness or cracking) and the safety phrase S24 (Avoid contact with skin). Criterion The preparation contains > 20%, in total, of relevant substances, which are assigned R66. 4.5.4 Rationale for assigning R66 For reasons of evident analogy, the guidance extends the exempt preparations from Xi, R38 only, as explicitly mentioned in the Directive, to preparations with severe acute skin classification R24 and R27. Solid substances are not taken into account because the physical form and non-availability will prevent any eventual effects. For existing solid substances, which however are not yet applied in coatings formulations; this practical experience is not yet known. Therefore the assigning criterion stands for these, for our industry, novel substances. By analogy of the DPD, the use of the 20% threshold value is a consequence of the approach providing warning for skin irritation. The EC recognises that the effect of skin dryness or cracking is a lesser effect than skin irritation. In setting the threshold at an equal 20%, we have adopted a conservative approach vis à vis the more serious irritation effect. Drowsiness and dizziness - R67 Exclusions R67 is not required for preparations that are classified and labelled with respect to acute inhalation toxicity with Xn; R20, R23, R26, R68/20, R39/23 or R39/26; or if the preparation is in a package containing 125 ml or less. This section of the guide should be ignored for such preparations. Assigning R67 to coatings R67 may be assigned to preparations irrespective of whether or not they are already classified for physico-chemical, other health or environmental effects. For coatings, volatile organic substances are likely to be the only raw material category to be assigned R67. Preparations meeting the criterion below are assigned R67 (Vapours may cause drowsiness and dizziness) and the safety phrase S51 (Use only in well ventilated areas) Document1 CEPE Labelling Guide 11th edition – Part 1 23 Criterion When a preparation contains one or more substances assigned the phrase R67, the preparation must be labelled with R67 when the total concentration of these substances is equal to or greater than 15%, unless any of the above exclusions apply. Rationale for assigning R 67 Commission Directive 2001/60/EC which is the first adaptation to technical progress to DPD, has specified the criteria, including the concentration limit, by which the R67 is to be assigned to preparations. 4.5.5 Preparations containing a substance assigned R33 When a preparation contains at least one substance assigned the phrase R33 in a concentration of 1 % or more, unless a different value is set in Annex VI, Part 3, Table 3.2 of CLP, the label of the preparation must carry the wording “Danger of cumulative effects”(=R33). 4.5.6 Preparations containing a substance assigned R64 When a preparation contains at least one substance assigned the phrase R64 in a concentration of 1 % or more, unless a different value is set in Annex VI, Part 3, Table 3.2 of CLP, the label of the preparation must carry the wording “May cause harm to breastfed babies” (=R64). Document1 CEPE Labelling Guide 11th edition – Part 1 5. 24 SPECIAL PACKAGING REQUIREMENTS 5.1 General 5.1.1 Packages and closures shall be designed and constructed in such a way as to preclude any unintentional loss of the contents. This requirement shall not apply where special safety devices are prescribed. 5.1.2 The packaging and closures must be made of materials that are not liable to be attacked by the contents or liable to form harmful or dangerous compounds with the contents. 5.1.3 The packaging and closures shall be strong and solid throughout so as to ensure that they will not come apart and will safely withstand the stresses and strains of normal handling4. 5.1.4 Containers, which contain dangerous preparations offered or sold to the general public, shall not have: - a shape and/or graphic decoration likely to attract or arouse the active curiosity of children or to mislead consumers or - a presentation and/or a designation used for foodstuffs, medicinal or cosmetic products. 5.1.5 Receptacles containing certain categories of dangerous substances and preparations, offered or sold to the general public might be subject: - to be fitted with a child resistant fastening and/or - to carry a tactile warning of danger 5.2 Specific rules 5.2.1 Child resistant fastenings Substances or preparations supplied (in any size container) to the general public which are labelled with any of the following indications of danger come under the requirements for child resistant fastenings in the DPD: - Substances or preparations supplied (in any size container) to the general public which are labelled with the following indications of danger: - very toxic - toxic - corrosive preparations containing methanol in a concentration equal or more than 3% by weight. 4 Various international transport regulations already cover the rules laid down in the Directive Document1 CEPE Labelling Guide 11th edition – Part 1 25 preparations containing dichloromethane in a concentration equal or more than 1% by weight. liquid substances and preparations presenting an aspiration hazard (see 4.5.1) and classified and labelled accordingly, except where such a preparation is supplied in an aerosol dispenser or a container fitted with a sealed spray attachment. If the packaging of such products is reclosable, then it will have to be made child resistant by fitting with a replaceable closure that complies with ISO 8317: 2003, relating to "child-resistant packaging requirements and methods of testing for reclosable packaging". Performing the test for child resistant closures will not be necessary if the person supplying the substance or preparation can show that it is obvious that the packaging is sufficiently safe for children because they cannot gain access to the contents without the help of a tool. The national authority can ask for certification from a qualified test house (a laboratory conforming to European Standards Series EN 45000) stating that: - the closure is such that it is not necessary to test to ISO 8317 or - the closure has been tested and found to conform to that standard. 5.2.2 Tactile warnings of danger Substances or preparations supplied (in any size container) to the general public, which are labelled with any of the following indications of danger come under the requirements for tactile warnings of danger in the DPD: - very toxic - toxic - corrosive - harmful - extremely flammable (not applicable for aerosols) - highly flammable (not applicable for aerosols) The packaging of such products must carry tactile warning(s) of danger in accordance with ISO 11683:1997. Document1 CEPE Labelling Guide 11th edition – Part 1 5.2.3 26 Preparations not classified as sensitising but containing at least one sensitising substance The packaging of preparations containing at least one substance classified as sensitising and being individually present in a concentration of 0.1 % or more (or that specified in Annex VI, Part 3, Table 3.2 of CLP) must bear the inscription: “Contains (name of the sensitising substance(s)). May produce an allergic reaction”. See Appendix 1.2 for specific P99 phrase. 5.2.4 Preparations containing halogenated hydrocarbons The packaging of liquid preparations which show no flash point or a flash point higher than 55 °C and contain a halogenated hydrocarbon and more than 5 % flammable or highly flammable substances must bear the inscription as appropriate: “Can become highly flammable in use” or “Can become flammable in use”. See Appendix 1.2 for specific P100 phrase. Document1 CEPE Labelling Guide 11th edition - 27 Appendix 1.1 SELECTION of S-PHRASES R-phrase for Professional use mandatory any recommended 35 or 60 for General Public use mandatory 2 recommended 35 or 56 not with R50 to R59 7 3 or 47 7 for organic 7 3 or 47 7 for organic peroxide 7 17 14 36,37,39 17 peroxide 14 36,37,39 50 50 with certain org. peroxides 8 or 9 50 50 with certain org. peroxides 17 51not needed if S38 is 17 51not needed if S38 is assigned assigned 43 if water should not be 43 if water should not be used for fire fighting used for fire fighting 46 unless no danger of swallowing 10 51not needed if S38 is 51not needed if S38 is assigned assigned 43 if water should not be 43 if water should not be used for fire fighting used for fire fighting 46 unless no danger of swallowing 11 or 12 9 16 33 9 16 29 for liquids immiscible with water 14 or 15 7 43 if water should not be 46 unless no danger of used for fire fighting swallowing 51 7 for organic peroxides 8 43 7 51 7 for organic peroxides 8 43 46 unless no danger of swallowing. 17 5 6 5 6 46 unless no danger of swallowing. 20-21-22 13 36 only with R21 22 only for solids in case of inhalation hazards 37 only with R21 36 only with R21 22 only for solids in case of inhalation hazards 37 only with R21 23 for liquids in case of 23 for liquids in case of inhalation hazards inhalation hazards 46 unless no danger of swallowing 51 51 Document1 CEPE Labelling Guide 11th edition R-phrase for Professional use mandatory 23-24-25 or 26-27-28 28 for General Public use recommended 22 only for solids in mandatory 1 recommended 13 case of inhalation hazards 22 only for solids in case of inhalation hazards 23 for liquids/gases in case 23 for liquids/gases in case of inhalation hazards of inhalation hazards 27 not needed if S36 is 27 only with R27 27 only with R24 assigned 28 only with 28 28 only with R26,27,28 28 R26,27,28 36 only with R24 or 36 only with R24 or R26,27,28 R26,27,28 37 only with R24 or 38 or 51 37 only with R24 or R26,27,28 38 or 51 R26,27,28 39 39 45 45 63 only with R23,26 7 8 7 risk if in contact with 29 31-32 63 only with R23,26 56 7 8 7 risk if in contact with acids 50 risk if in contact with acids acids 50 risk if in contact with acids 33 13 22 22 only for solids in case of inhalation hazards only for solids in case of inhalation hazards 23 for liquids in case of 23 for liquids in case of inhalation hazards inhalation hazards 46 unless no danger of swallowing. 34-35 26 1 26 25 28 36 37 39 45 36-37-38 25 28 if water should not be used for fire fighting if water should not be used for fire fighting 36 37 39 45 24 or 36 only with R38 25 only with R36 26 only with R36 46 unless no danger of 64 24 or 36 only with R38 25 only with R36 26 only with R36 64 swallowing. 39/23-24-25 39/26-27-28 40 41 same same same 25 26 39 as as as R 23 - 24 - 25 R 26 - 27 - 28 R 20 - 21 - 22 25 26 39 46 unless no danger of swallowing. Document1 CEPE Labelling Guide 11th edition R-phrase 42 for Professional use mandatory 22 only for solids in 29 for General Public use recommended mandatory 22 only for solids in case of inhalation hazards case of inhalation hazards 23 for liquids in case of 23 for liquids in case of inhalation hazards inhalation hazards 45 recommended 13 45 46 unless no danger of swallowing. 63 43 24 except if S36 24 except if S36 already assigned already assigned 37 45 or 46 or 49 37 22 only for solids in case of inhalation hazards must not be sold must not be sold 23 for liquids/gases in case of inhalation hazards must not be sold must not be sold must not be sold must not be sold must not be sold must not be sold must not be sold must not be sold 36 37 53 48/20-21-22 48/23-24-25 50 or 50-53 51-53 52 or 52-53 53 60 or 61 28 s a m e a s R 20 - 21 - 22 s a m e a s R 23 - 24 - 25 61 29 61 29 61 61 36 37 53 22 only for solids in case of inhalation hazards 23 for liquids/gases in case of inhalation hazards 27 28 1 62 or 63 36 37 61 61 61 61 must not be sold must not be sold must not be sold must not be sold must not be sold must not be sold must not be sold must not be sold must not be sold must not be sold must not be sold must not be sold 1 36 13 22 only for solids in case of inhalation hazards 37 23 for liquids/gases in case of inhalation hazards 46 unless no danger of swallowing. 64 No S-phrase 65 66 67 68 Intended for Spraying (for dangerous preparations) 23 38 (for T+ or T or 51 preparations) 62 unless S45 or S46 62 unless S45 or S46 are assigned are assigned 24 51 Same as R 20, 21, 22 23 38 (for T+ or T preparations) or 51 24 51 Document1 CEPE Labelling Guide 11th edition - 30 Prioritization of S-Phrases The final choice of safety phrases must have regard to the risk phrases indicated on the label and to the intended use of the preparation. A maximum of six phrases may be as a general rule sufficient to cover the need for the appropriate safety advice. The selection of phrases should reflect the profile of the physico-chemical, health and environmental effects of the preparation and its intended use. Combined phrases shall be regarded as single phrases. For situations where more than six phrases will be selected following the guideline for the selection of S-phrases in Appendix 1.1: Mandatory phrases overrule recommended phrases. Avoid S-phrases with almost identical meaning as the R-phrases (e.g. R20 together with S23) If at least one S-phrase has been already been assigned to all three danger categories, additional S-phrases connected to health hazard effects have first priority, physical-chemical effects second priority and phrases connected to the danger to the environment third priority. Where it is physically impossible to give all the safety advice (S-phrases) on the label, the package shall be accompanied by additional safety advice on the use of the preparation. Document1 CEPE Labelling Guide 11th edition - 31 APPENDIX 1.2 SELECTION of P-PHRASES Under this heading, are listed the official special phrases, which have been given “P phrase” references by CEPE, and voluntary industry phrases. 1a. Official special phrases 1.1 Paint containing lead compounds P90 use: for preparations which contain more than 0.15% by weight of lead (on the total preparation as supplied) for packaging 125 ml a) “Contains lead. Should not be used on surfaces liable to be chewed or sucked by children” for packaging < 125 ml b) “Warning. Contains lead” Source: Annex V of DPD, B-1.1 1.2 Preparation containing isocyanates P91 “Contains isocyanates. See information supplied by the manufacturer” use: for preparations containing isocyanates (monomers, oligomers, prepolymers, as such or as mixtures). See also paragraphs. 4.5.2 and 5.2.3 Source: Annex V of DPD, B-3 1.3 Preparation containing epoxy compounds with a MW 700 P92 “Contains epoxy constituents. See information supplied by the manufacturer” use: for preparations containing substances with epoxy constituents with an average molecular weight 700. See also paragraph 5.2.3. Source: Annex V of DPD, B-4 Document1 CEPE Labelling Guide 11th edition - 1.4 32 Disposal of emptied containers P94 “Empty containers should be disposed of in accordance with the requirements of [national associations to add appropriate legislative references]” use: for the emptied containers of preparations that are subject to restriction or control on disposal routes Source: Packaging and Packaging Waste Directive 94/62/EC, Annex V of DPD, A-1.2 1.5 Restricted for professional use P95 “Restricted to professional users” use: for preparations that contain a substance specified in points 29., 30. and 31. of the Annex XVII to REACH Regulation, and are classified and labelled as either - category 1 or 2 carcinogens, - category 1 or 2 mutagens or - category 1 or 2 toxic for reproduction. Source: REACH Regulation, Annex XVII 1.6 Aerosols P96 “Pressurised container: protect from sunlight and do not expose to temperature exceeding 50°C. Do not pierce or burn, even after use” P97 “Do not spray on a naked flame or any incandescent material Keep away from sources of ignition – No smoking Keep out of reach of children” Source: Annex to Aerosol Directive 94/1/EC, Annex V of DPD, B-7 1.7 Preparations not classified as sensitising but containing at least one sensitising substance P99 "Contains (name of sensitising substance(s)). May produce an allergic reaction" Document1 CEPE Labelling Guide 11th edition - 33 Use: Preparations containing at least one substance classified as sensitising and being present in a concentration equal to or greater than 0.1 % or in a concentration equal to or greater than that specified under a specific note for the substance in Annex I to DSD must bear this inscription: Source: Annex V DPD, B-9 1.8 Liquid preparations containing halogenated hydrocarbons P100 a) "Can become highly flammable in use" or b) "Can become flammable in use" Use: For liquid preparations which show no flash point or a flash point higher than 55°C and contain a halogenated hydrocarbon and more than 5% flammable or highly flammable substances, the packaging must bear one of these inscriptions depending on the flash point.. Source: Annex V DPD, B 10 1.9 Preparations not classified but containing at least one dangerous substance P101 "Safety data sheet available for professional user on request" Use: For such preparations intended for professional users, the label on the packaging of the preparations must bear this following inscription: Source: Annex V DPD, C 1 1.10 Paints (other than spray paints) butoxyethoxyethanol (DEGBE) containing ≥ 3% 2-(2- P102 “Do not use in paint spraying equipment” Use: for paints, other than spray paints, containing ≥ 3% DEGBE that are placed on the market for supply to the general public. They shall be visibly, legibly and indelibly marked by 27 December 2010. Source: item 54 of the Annex to Decision No 1348/2008 amending MUD 76/769//EEC, becoming REACH Annex XVII after 30 June 2009. Document1 CEPE Labelling Guide 11th edition 1.11 34 Preparations containing ≥ 0.1% Methylenediphenyl diisocyanate (MDI) P103 − “— Persons already sensitised to diisocyanates may develop allergic reactions when using this product. − Persons suffering from asthma, eczema or skin problems should avoid contact, including dermal contact, with this product. − This product should not be used under conditions of poor ventilation unless a protective mask with an appropriate gas filter (i.e. type A1 according to standard EN 14387) is used.” Use: For preparations containing ≥ 0.1% MDI sold to the general public together with the supply of certain protective gloves after 27 December 2010. Source: item 55 of the Annex to Decision No 1348/2008 amending MUD 76/769//EEC, becoming REACH Annex XVII after 30 June 2009. 1.12 Paint strippers containing ≥ 0.1% Dichloromethane (DCM) P104 “Restricted to industrial use and to professionals approved in certain EU Member States – verify where use is allowed.” Use: for paint strippers containing dichloromethane in a concentration ≥ 0.1% by 6 December 2011 Source: item 58 of the Annex to Decision No 455/2009 amending MUD 76/769//EEC, becoming REACH Annex XVII after 30 June 2009. Document1 CEPE Labelling Guide 11th edition - 35 APPENDIX 1.3 Directives amendments and adaptations relevant to this Guide Recent EU legislation with a relevance to coatings* Reference Keys: DPD DPD 1st ATP DPD AMD (2nd ATP) 1999/45/EC 2001/60/EC 2006/8/EC DSD 67/548/EEC DSD 7th AMD DSD 14th ATP DSD 16th ATP DSD 18th ATP 92/32/EEC 91/410/EEC 92/37/EEC 93/21/EEC DSD 19th ATP DSD 20th ATP DSD 21st ATP DSD 22nd ATP DSD 23rd ATP DSD 24th ATP DSD 25th ATP DSD 26th ATP DSD 27th ATP DSD 28th ATP DSD 29th ATP DSD Amendment DSD Amendment 93/72/EEC 93/101/EC 94/69/EC 96/54/EC 97/69/EC 98/73/EC 98/98/EC 2000/32/EC 2000/33/EC 2001/59/EC (Art 1.1 & 5) 2004/73/EC 2006/102/EC 2006/121/EC AD AD 1st ATP AD 2nd ATP 75/324/EEC 94/1/EC 2008/47/EC BPD 98/8/EC VOC Product Directive 2004/42/CE Detergent Regulation (EC) No 648/2004 REACH Regulation (EC) No 1907/2006 CLP Regulation (EC) No 1272/2008 AD AMD ATP BPD CLP Aerosols Directive Amendment Adaptation to Technical Progress Biocidal Products Directive Classification, Labelling and Packaging Regulation DPD Dangerous Preparations Directive DSD Dangerous Substances Directive MUD Marketing and Use Directive REACH: Regulation of Registration ; Evaluation and Authorisation of Chemicals SDSD Safety Data Sheet Directive VOC Volatile Organic Compound Document1