Amended proposal for a European Parliament and Council Directive concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations
COMMISSION OF THE EUROPEAN COMMUNITIES £ it -il -tr Brussels, 23. 09. 1997 COM(97) 462 final 96/0200 (COD) Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE concerning the approximation of the laws, regulations and administrative provisions of ihe Member States relating to the classification, packaging and labelling of dangeiimc preparations (presented by the Commission pursuant to Article 189 a (2) of the EC-Treaty) EXPLANATORY MEMORANDUM 1. Introduction Pursuant to Article 189(a) paragraph 2 of the EC Treaty, the Commission submits an amended proposal for an European Parliament and Council Directive concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations. The amended proposal takes account a number of amendments from the European Parliament, adopted at its Plenary Session on 26 June 1997. The Parliament adopted 26 amendments (originally 28, but amendment 10 was included in amendment 11 and amendment 23 in amendment 22). The amendments are related to the following topics: labelling, classification, packaging, other issues and editorial issues. Out of 26 amendments the Commission can accept 13 as such and 3 amendments are acceptable in principle. Amendments relating to following issues are not acceptable: Article 3(3) (amendment 4) Article 10 paragraph 2. 3. 1 (amendment 8) Article 10 paragraph 2. 3. 2 (amendment 9) Article 10 paragraph 2. 3. 3 (amendment 11) Article 10 paragraph 2. 3. 4 (amendment 12) Article 10 paragraph 2. 3. 4 a (new) (amendment 13) Article 15, paragraph 1 (new) (amendment 16) Article 16 paragraph 2, first indent (amendment 40) Annex III, part C, paragraph 4, (amendment 20) Annex V, Part C (1) (first part of amendment 22) Annex V, Part Cb (new) (amendment 26). 2. Labelling The new recital 13 (a) (amendment 1) emphasises the need to launch a study on comprehensibility of contents of labels and to review the existing rules on labelling, if necessary. The Commission welcomes this amendment and will launch this study as soon as possible. Amendments to Article 10 paragraph 2. 3. 1 (amendment 8), paragraph 2. 3. 2 (amendment 9), paragraph 2. 3. 3 (amendment 11), paragraph 2. 3. 4 (amendment 12) and paragraph 2. 3. 4 a (new) (amendment 13) would result in a label overloaded with chemical names whilst not improving the level of protection. The Commission is, by accepting a new recital 13 (a) (amendment 1), committing itself to launch, as soon as possible, a study on Reference - minutes of the session of 26 June 1997, Baldi report A4-0186/97 2 the comprehensibility of labels to the users. This study will examine all labelling issues, including those raised by amendments 8, 9, 11, 12 and 13. Based on the results of this study the Commission will review all labelling requirements. Therefore the amendments proposed on naming of substances on the label are not accepted by the Commission. Amendment to Article 10 paragraph 4, first indent (amendment 14) introduces an exemption from full labelling requirements also to be applied to preparations classified as dangerous for the environment, when the preparation is supplied in small packages (volume less than 125 ml). This amendment is acceptable and justified by the fact that such small amounts of chemicals would not cause risk to the environment. Though full labelling is not required the packages have to be labelled in any case by a warning symbol indicating the danger to the environment. Amendment to Article 10 paragraph 5 (amendment 15) prohibits using on labels of preparations covered by the Directive expressions such as "environmentally friendly'' and "ecological" or an expression that leads to an underestimation of the danger. This amendment completes the text of the Commission's original proposal by adding examples of such expressions which are related to environmental properties. Amendment to Annex V, Part C (1) (amendment 22) addresses the specific warning on sensitising effects to all persons. The Parliament's amendment for a more general version covers in any case the target population and is therefore acceptable to the Commission. Amendment to the first part of paragraph 1 of Annex V Part C (corresponding to the original amendment 23 and combined with amendment 22) is not acceptable to the Commission. It relates to labelling of sensitisers and would make the proposed provision unworkable. The approach proposed by this amendment does not specify any limit for the specific warning on sensitising effects. In practice this would mean that the general limit of 1 % defined in Article 3 of the proposal will apply to all sensitisers. The Commission thinks that this limit is too high to trigger this requirement. Amendment to Annex V Part C (2) (amendment 24) introduces a modification of the specific phrase for packages of non-classified preparations for which the Safety Data Sheet is available on request. The label is to be placed on preparations used exclusively by professional users. Such preparations are not available to the public at large. The label is put only on preparations which are not classified as dangerous. Since this amendment supports the provision on a Safety Data Sheet for non classified preparations the Commission can accept it in a slightly modified form. Amendment to Annex V, Part Ca (new) (amendment 25) proposes a specific part of Annex V to be introduced for labelling of Plant Protection Products. The Commission agrees that this part to Annex V is necessary. Amendment to Annex V, Part Cb (new) (amendment 26) proposes a specific part of Annex V to be introduced for labelling of Biocides. The Commission cannot accept this amendment as it contradicts the position taken by the Parliament and the Council on the proposal for the Directive on Biocides which has already passed its second reading. 3. Classification Amendment to Article 3(3) (amendment 4) would introduce changes to application of the conventional method. The Commission cannot accept this amendment as it would eventually lead to unnecessary animal testing because the conventional method would be unworkable. Amendment to Article 6 paragraph 3 (amendment 6) introduces restrictions on animal testing in cases where alternative methods are available and also provides for provisions on specification of data on effects on man. The Commission welcomes this amendment but introduces it in a reworded form. The new formulation of paragraphs 1 and 2 enables references to harmonised in vivo and in vitro test methods of Annex V to Directive 67/548/EEC. The formulation of paragraph 3 clearly states as amendment 6, that the conventional method or the in vitro test methods (alternative methods) are given the preference in classification of preparations. The in vivo methods using vertebrate animals could only be used in cases where the person responsible for placing on the market can demonstrate that the alternative methods cannot be used. The results of existing animal tests can be used for classification. to Annex III, Part B, Table V (amendment 18) introduces a lower Amendment concentration limit (0,1 % instead of 0,5%) for classification of preparations containing ozone depleting substances. The amendment will ensure a high level of protection by laying down the practice already existing, as the marketing of ozone depleting substances has already been prohibited by Regulation 3093/94. Amendment to Annex III, Part C, paragraph 4 (amendment 20) provides that the existing test results should be applicable for assessment of effects dangerous for the environment. According to the Commission's view this is superfluous as this is already the case. 4. Packaging Amendment to Article 9 paragraph 2 (new) (amendment 7) lays down the practice already existing between transport and supply packages. This amendment improves the clarity of the legislation. Amendment to Annex IV, Part B, paragraph 2 (new) (amendment 21) removes the requirement for a tactile danger warning (a special warning for blind persons) on aerosols classified as extremely flammable and highly flammable. This amendment is introduced at the request of the European Blind Association. According to the Commission this amendment can be accepted but recognises at the same time that there is a need to the comprehensibility of the system of warnings for blind and visually examine if necessary. This the present handicapped persons, and examination can be linked to the study introduced by the new recital 13 (a). legislation, to review OJNo. L 333 ,22. 12. 1994, p. 1 5. Other issues Amendment to Article 15 paragraph 1 (amendment 16) goes beyond what is the Commission's intention with this provision. The intention of the Commission's proposal is not to introduce provisions for advertisement, but to deal with a very specific situation of offering a product for sale on the market through the so-called "distance selling". Amendment 16 is not accepted by the Commission. Amendment to Article 16 paragraph 2, first indent, (amendment 40) is related to Safety Data Sheets for non-classified preparations. Although the Commission understands the rationale for this amendment the Commission would like to have more time to examine in depth what kind of consequences such an amendment will have in practice and, in particular, in relation to the implementation of such a requirement by the small and medium size enterprises. All classification and labelling rules concerning preparations deemed dangerous for the environment, as well as the obligation to establish a Safety Data Sheet for non-classified preparations, are completely new elements in the field of harmonised rules for dangerous preparations. The introduction of this additional requirement could increase further the burden on industry. Commission cannot therefore accept this amendment. Article 21 of the Commission's original proposal specifies the Committee procedure which will be used in the context of Directive on dangerous preparations leaving open, however, which of the two Committee procedures specified in Article 29 of Directive 67/548/EEC will be applied. Article 20a (new) (amendment 17) adopted by the Parliament specifies exclusively the Committee procedure which is applied to adaptation for technical progress of the Directive. The reworded amendment should replace the text of Article 21. This amendment is acceptable in principle to the Commission as it makes the provision more transparent. The text of the amendment should be reworded to take into consideration the fact that the Committee is the same as in the context of Directive 67/548/EEC. Amendment to Annex VIII, Part A (amendment 27) proposes that reference to Directive 96/65/EC should be added to the list of Directives that need to be repealed. This amendment is acceptable and necessary. 6. Editorial issues Amendments to Article 1 paragraph 1, (amendment 2), to Article 1 paragraph 3 (amendment 3), to Article 4 paragraph 2 (amendment 5), to Article 10 paragraph 2. 3. 3 (amendment 10 included in amendment 11) and to Annex III, Introduction to paragraphs 1 (a) to 1 (e) (amendment 19) are editorial and they improve the text. The Commission has introduced a clarification on the heading of Article 15 to bring it in line with its contents. Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations Pursuant to Article 189(a) paragraph 2 of the EC Treaty, the Commission has decided to amend the proposal3 for an European Parliament and Council Directive concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations as follows: Original proposal Modified proposal Recital 13 a (new) a report submit the Whereas the Commission will, on basis of information to be supplied by the Member States and the various parties concerned, the to the Council European Parliament and within two years of the entry into force of this Directive on experience with the present overall approach to labelling of dangerous preparations and in particular on its understanding and application by users. publicity campaigns and educational and training programmes: whereas on the basis of this will. report if the necessary appropriate. proposals: Commission the submit experience with Article 1(1) This Directive 1. the approximation of the laws, regulations and administrative provisions of the Member States concerning: aims at This Directive 1. the approximation of the laws, regulations and administrative provisions of the Member States concerning: aims at the classification, packaging and labelling of dangerous preparations, specific provisions for certain preparations which may present hazards, whether or not they are classified as dangerous within the meaning of this Directive, when such preparations are placed on the market. OJ No C 283, 26. 9. 1996, p. 1 the classification, packaging and for labelling of dangerous preparations, specific provisions certain preparations which may present hazards, whether or not they are classified as dangerous within this Directive, when such preparations are placed on the market of the Member States. the meaning of Article 1(3) 3. The specific provisions set out: in Article 9 and defined in Annex IV, 3. The specific provisions set out: in Article 9 and defined in Annex IV, in Article 10 and defined in in Article 10 and defined in Annex V, and in Article 16 this Directive shall also apply of to preparations which are not considered dangerous within the meaning of Articles 5, 6 or 7 but may nevertheless present a hazard to the user. Annex V, and in Article 16 of to this Directive shall also apply preparations which are not considered dangerous within the meaning of Articles 5, 6 or 7 but may nevertheless present a specific hazard to the user. Article 4(2) labelling The general principles of the 2. classification of and preparations shall be applied according to the criteria in Annex VI to Directive 67/548/EEC alternative save where criteria referred to in Articles 5, 6 or 7 of this Directive are applied. and labelling The general principles of the 2. classification of preparations shall be applied according to the criteria in Annex VI to Directive 67/548/EEC alternative save where criteria referred to in Articles 5, 6, 7 or 10 and the corresponding Annexes of this Directive are applied. Article 6(1), (2) and (3) The health a 1. preparation shall be assessed by one or more of the following procedures : hazards of 1. The health hazards of a preparation shall be assessed by one or more of the following procedures: by the (a) conventional method described in Annex II parts A and B to this Directive using concentrationiimits; by the (a) conventional method described in Annex II parts A and B to this Directive using concentration limits: Directive (b) by determining, by means of the methods specified in point B of Annex V 67/548/EEC the to the of toxicological preparation necessary for appropriate classification and labelling in accordance with the criteria in Annex VI to that Directive. properties in part B of Annex V (b) by determining, by means of the methods using vertebrate animals and specified to Directive 67/548/EEC, the toxicological properties of the preparation necessary for and labelling in accordance with criteria in Annex VI to that Directive; classification appropriate (c) by determining by means of the methods not using vertebrate animals and in part B of Annex V specified to Directive 67/548/EEC the toxicological properties of the preparation necessary for and labelling in accordande with the criteria in Annex VI to that Directive. classification appropriate 2. The health hazards of a preparation covered by Directive 91/414/EEC shall the be assessed by one or more of following procedures: hazards health covered a 2. The preparation by Directive 9I/414/EEC shall be assessed by one or more of the following procedures : of by the (a) conventional method described in Annex II parts A and B to this Directive using concentration limits; by the (a) conventional method described in Annex II parts A and B to this Directive using concentration limits; appropriate classification by determining the health effect (b) properties of the preparation necessary for in accordance with criteria of Annex VI to Directive 67/548/EEC. These health effect properties will be determined by means of the methods laid down in part B of Annex V to Directive 67/548/EEC unless other internationally recognized methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC. When a toxicological property 3. is established by method Kb) or 2fb) to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Directive 87/18/EEC4 and with the provisions of Directive 86/609/EEC. OJNo. L 15, 17. 1. 1987, p. 29 unless in part B of Annex V 67/548/EEC. the (b) by determining, by means of methods using vertebrate animals and to specified Directive other internationally recognised methods are acceptable the provisions of Annexes II and III of Directive 91/414/EEC, the toxicological properties of the preparation necessary for and labelling in accordance with the criteria in Annex VI to Directive 67/548/EEC: accordance with classification appropriate in internationally (c) by determining, by means of the methods not using vertebrate animals and specified in part B of Annex V to Directive 67/548/EEC. unless other recognised methods are acceptable in accordance with the provisions of Annexes II and HI of Directive 91/414/EEC. toxicological properties of the preparation necessary for appropriate classification and labelling in accordance with the criteria in Annex VI to Directive 67/548/EEC: the placing responsible on for the market 3. Where it can be demonstrated by the the person preparation a toxicological property of a preparation cannot be determined by method 1 (a) or 1 (c). or by method 2(a) or 2 (c). or on the basis of existing test results on vertebrate animals, the methods 1 (b) or 2 that Any of the toxicological properties of the preparation which are not assessed by the method set out in Kb) or 2(b) above shall be assessed the conventional method. in accordance with for classifying Where a toxicological property has been established by both the methods above, the result of method Kb) or 2(b) shall be used the preparation except the case of carcinogenic. mutagenic effects and toxic effects for reproduction the for which conventional method described in Annex II applies. only in (b) may be used. the specified test methods Where a health hazard has been assessed by in paragraphs 1(b) or 1(c). or 2(b) or 2(c). these methods for shall classifying the preparation instead of the conventional method, except in the case of carcinogenic, mutagenic effects and toxic effects for reproduction for which only the conventional method described in Annex II applies. used be Where results of both methods Kb) and 1(c). or 2(b) and 2(c) are available- method 1(b) or 2(b) shall normally be used for classifying the preparation. Furthermore, demonstrated that : where it can be Furthermore, demonstrated: where it can be suggested by - toxicological effects on man differ from toxicological those determination conventional assessment, then the preparation shall be classified according to its effects on man, or a a or of by use studies, preparations epidemiological by scientifically valid case studies based on the by statistically-backed experience, such as from poison the assessment of data occupational or information diseases that toxicological effects on man differ In those application of methods provided for in paragraphs 1 or 2. then the preparation shall be classified according to its effects on man. suggested units from - owing to effects such as potentiation a conventional would underestimate the toxicological hazard, these effects shall be taken into account in classifying the preparation, assessment - owing to effects such as antagonism, a assessment conventional would overestimate toxicological hazard, these effects shall be taken into account in classifying the preparation. the 10 to such effects that owing - as potentiation a conventional assessment would underestimate toxicological hazard, these effects shall be taken into account in classifying the preparation. the to such effects that owing - as antagonism, a conventional assessment would overestimate toxicological hazard, these effects shall be taken into account in classifying the preparation. the Article 9, 2nd paragraph (new) 2. Preparations shall be deemed to satisfy the requirements of point 1. first to third indents, if their packaging complies with the requirements for carriage by rail road, inland waterway, sea or air. Article 10(2. 3. 3) (2. 3. 4(a) (new) classified 2. 3. 3. for preparations as sensitizing, in accordance with Article 6, only the sensitizing substances present in concentrations equal to or greater than their respective limits laid down in Annex I to Directive 67/548/EEC or, failing that. Annex II B of this Directive have to be taken into consideration. classified for preparations 2. 3. 3. as sensitizing, in accordance with Article 6, only the sensitizing substances present in concentrations equal to or greater than their respective limits laid down in Annex I to Directive 67/548/EEC or, failing that, Annex II B of this Directive have to be taken into consideration. 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 the choice of the corresponding phrases referring to the risk involved. In some cases, more than four chemical names may be necessary. the substances 2. 3. 4 (a) As a general rule a maximum of four chemical names shall suffice to identify primarily responsible for the major health hazards which have given rise to the classification and the corresponding phrases referring to the risk involved. In some cases, more than four chemical names may be necessary. the choice of Article 10(4), first indent in the case of irritant, highly flammable and oxidizing preparations with the exception of those assigned the phrase R41, there is no need to indicate the special risks (R phrases) or the safety advice (S phrases); 11 in oxidizing the case of irritant, highly flammable, and environmentally dangerous preparations with the exception of those assigned the phrase R41, there is no need to indicate the special risks (R phrases) or the safety advice (S phrases); Article 10(5) 5. Information such as 'non-toxic', 'non-harmful' or any other statement indicating is not the dangerous must not appear on packaging or labelling of the preparations subject to this Directive. the preparation that Information such as 'non-toxic'. 5. 'environmentally-friendly', 'non-harmful', 'eco' or any other statement indicating that the preparation is not dangerous or which might lead to an underestimation of the hazards of such preparations must not appear on the packaging or labelling of this Directive. the preparations subject to Article 15 Advertisements Distance selling exclusively the meaning of Any advertisement for a preparation within this Directive communicated by catalogue which correspondence imposes an obligation on the buyer shall be prohibited is made therein of the type or types of hazard indicated on the label. if no mention or Article 21 exclusively the meaning of for a preparation Any advertisement this Directive within by communicated catalogue which correspondence imposes an obligation on the buyer shall be prohibited is made therein of the type or types of hazard indicated on the label. if no mention or to adapt Amendments to required technical progress the Annexes to this Directive shall be adopted in accordance with the procedure laid down in Article 29 of Directive 67/548/EEC. to adapt Amendments to required technical progress the Annexes to this Directive shall be adopted in accordance with the procedure laid down in Article of Directive 29 67/548/EEC. paragraph (a) 4 ANNEX III, Introduction, paragraphs 1A to IE (new) the Ihe systematic assessment of all dangerous properties for the environment is expressed by means of concentration limits, expressed as a weight/weight gaseous percentage preparations where they are expressed as a volume/volume percentage and in conjunction with the classification of a substance. except for 12 the The systematic assessment of all dangerous properties for the environment is expressed by means of concentration limits, expressed as a weight/weight gaseous percentage preparations where they are expressed as a volume/volume percentage and in conjunction with the classification of a substance. except for Part A gives the calculation procedure according to Article 7(l)(a) and 7(2)(a) and gives the R phrases to be assigned to the classification of the preparation. Part B gives the concentration limits to be the conventional used when applying method and the relevant symbols and R phrases for classification. Part C gives the test methods for the evaluation of the hazards for the aquatic environment- Part D gives the R phrases to use on the label Part E gives the indications concerning safety advice to put on the label. ANNEX III, Part B, Table V, second column, first line concentration > 0. 5% concentration >QJ_% ANNEX IV, Part B, 2nd paragraph (new) This provision shall not apply to aerosols classified and labelled only as extremely flammable or highly flammable. ANNEX V, Part C(l) substance Preparations containing at but dangerous least 1. one not classified within the meaning of Articles 5, 6 and 7. of The label preparations containing at least one substance classified as sensitizing and accompanied by a specific note under Annex I to Directive 67/548/EEC must bear the inscription: packaging the on substance Preparations containing at but dangerous least 1. one not classified within the meaning of Articles 5, 6 and 7. of The label preparations containing least one substance classified as sensitizing and accompanied by a specific note under Annex I to Directive 67/548/EEC must bear the inscription: packaging at the on "Contains 'name of sensitizing substance'. May produce an allergic in persons already sensitized" reaction "Contains 'name of sensitizing substance'. May produce an allergic reaction/" 13 ANNEX V, Part C(2) Preparations not intended for the 2. general public. The the label on preparations referred to in Article 16. 2 must bear the following inscription: 'Safety data sheet available on request' the packaging of the packaging of Preparations not intended, for the 2. general public. The the label on preparations referred to in Article 16. 2 must bear the following inscription: 'Contains dangerous substances in such amounts is not justified. Safety data sheet available on request. ' that warning label ANNEX V, Part D (new) Special provisions for D. preparations placed on the market solely as authorized plant protection products pursuant to Directive 91/414/EEC. ANNEX VIII, Part A, 2nd indent, 3rd subindent a (new) on Directive the 88/379/EEC approximation of the laws of the Member classification, to relating States packaging and labelling of dangerous preparations and its following adaptations progress: technical the to on Directive the 88/379/EEC approximation of the laws of the Member classification, relating States to packaging and labelling of dangerous preparations and its following adaptations progress: technical the to -Directive 89/178/EEC - Directive 90/492/EEC -Directive 93/18/EEC -Directive 89/178/EEC - Directive 90/492/EEC -Directive 93/18/EEC - Directive 96/65/EC 14 ISSN 0254-1475 COM(97) 462 final DOCUMENTS EN 02 07 14 17 Catalogue number : CB-C0-97-477-EN-C ISBN 92-78-24908-4 Office for Official Publications of the European Communities L-2985 Luxembourg 4C