Opinion of the Economic and Social Committee on the '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` (97/C 158/11)

On 1 October 1996 the Council decided to consult the Economic and Social Committee, under Article 100a of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Protection of the Environment, Public Health and Consumer Affairs, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 7 March 1997. The rapporteur was Mr Gardner.

At its 344th plenary session on 19 and 20 March 1997 (meeting of 20 March 1997) the Economic and Social Committee adopted the following opinion by 94 votes in favour, two against and five abstentions.

1. Introduction

1.1. Dangerous preparations are currently regulated by Directive 88/379/EEC () which covers their classification, packaging and labelling. This proposal brings that Directive up to date while improving the presentation. The proposal also introduces the following new elements:

1.1.1. Plant-protection products (PPPs) are now included as regards their classification, packaging, labelling and safety data sheets (SDS). Directive 91/414/EEC () on the placing on the market of PPPs remains into force, however, but has to be amended to take into consideration the fact that Directive 78/631/EEC (), on the classification, packaging and labelling of pesticides, has been repealed.

1.1.2. The requirement for SDS is extended to certain preparations not classified as dangerous.

1.1.3. There is a new classification for environmental hazards. This is in line with the introduction of the corresponding criteria in Directive 67/548/EEC () relating to the classification, packaging and labelling of dangerous substances.

1.1.4. Obligation to label certain sensitizers, even below the general classification limits.

2. General comments

2.1. Most of these changes are timely and necessary. While the presentation is improved the proposal remains difficult for the ordinary layman, since much of the detail is found in other directives, especially Directive 67/548/EEC on dangerous substances. Nevertheless, the Committee approves it subject to the comments below.

2.1.1. The Committee confirms the importance of emphasizing to consumers any safety and environmental hazards of household and garden products so that they can take precautions and, where a choice exists, purchase alternatives.

2.1.2. Problems arise particularly with the following additions:

2.2. Introduction of plant-protection products (PPPs)

2.2.1. PPPs now have to follow the same general rules as the other preparations. This is a harmonization in general, especially as regards classification. The absence of specific labelling rules in the framework of this proposal is a potential source of confusion and misunderstanding for both users and enforcement authorities. Therefore, unambiguous rules have to be established from the start.

2.3. Inclusion of certain preparations not classified as dangerous

2.3.1. In addition to existing provisions, the new obligation requires the preparation of SDS. This raises a number of difficulties which are addressed in detail in point 3.11.

2.4. Environmental dangers

2.4.1. Environmental dangers are now treated with the same emphasis and detailed procedure as toxicological properties.

2.4.2. The annexes should deal only with the technical parts of the assessments. This highlights the principles (in the Articles) but allows more rapid adaptations of the technical part in line with progress, scientific or otherwise.

2.5. Alternative names

2.5.1. The proposal keeps the current limitations regarding the category of substances for which alternative names can be used, but introduces a procedure of approval of these alternative names. This is discussed in more detail in points 3.8 and 3.10.

3. Detailed comments

3.1. Article 1 - paragraph 4

3.1.1. This paragraph brings classification, labelling, packaging and SDS of PPPs into the rules of this proposal while continuing those completed under the specific Directive 91/414/EEC. Two different sets of labelling rules are likely to create confusion.

3.1.2. As the best solution, the Committee proposes that Directive 91/414/EEC be amended as necessary and enter into force at the same time as the present proposal. The particular case of labelling is covered in point 3.7 below.

3.2. Article 1 - paragraph 5

3.2.1. This directive does not apply to transport and transport packaging. The Commission should work within the relevant international bodies to bring transport provisions (as laid down, for example, in Directive 94/55/EC of 21 November 1994) into line with this directive as regards classification, packaging and labelling.

3.3. Article 5 - Evaluation of hazards deriving from physico-chemical properties

3.3.1. The mechanism of evaluation in general is unchanged but there is a new clause which avoids unnecessary re-runs of tests. This seems sensible.

3.4. Article 6 - Evaluation of health hazards

3.4.1. The permitted variations have been increased in the light of practical experience. However it needs to be made clear that this rule only applies in the rare cases where properties of the preparation is first assessed by testing rather than by calculation from the constituents.

3.4.2. Here again this revised clause avoids unnecessary re-testing. In this case, this will reduce the number of animal tests required.

3.5. Article 7

3.5.1. This is new and covers, in connection with Annex III, the evaluation of environmental hazards. The method very sensibly mirrors that for toxicological evaluation.

3.5.2. See also point 2.4 above.

3.6. Article 8 - paragraph 4

3.6.1. This is new and will help both with enforcement and with applying the directive.

3.7. Article 10 - paragraph 1.2 - Labelling of PPPs

3.7.1. As indicated under point 3.1, labelling is the special difficulty resulting from the inclusion of PPPs in the general directive. The Committee proposes that an Annex under this directive give clear, unambiguous rules for labelling these products. As stated in paragraph 3.1, this, together with the necessary amendments of Directive 91/414/EEC, needs to be achieved at the latest when the proposal comes into force.

3.8. Article 10 - paragraph 2.3.5 - Use of alternative names

3.8.1. This Article allows alternative names only for substances which are harmful owing to acute lethal effects.

3.8.2. The label must show all data necessary for the information of consumers and users. It is also necessary to take into account current regulations protecting industrial know-how as far as this does not endanger safety of users and consumers. This can be done using the Lexicon/Guide in Annex VI Part B.

3.9. Article 10 - paragraphs 2.5 and 2.6

3.9.1. These can now result in up to 6 Risk phrases plus 6 Safety Advice phrases on the same label. While 6 R phrases may only occur occasionally for very dangerous products, 6 S phrases may become quite common.

3.9.2. That many on top of the chemical names requires that the information is really necessary and intelligible. At the workplace, however, more complete and precise information is already given on the SDS.

3.9.3. Without prejudice to the provisions of the proposed directive, the Committee invites the Commission to carry out a study on the need for existing labelling and how this is understood by the general public and users. Based on results of this study, the criteria of Annex VI to Directive 67/548/EEC for labelling dangerous substances and preparations should be reviewed as necessary, and ways and means to educate the general public be examined.

3.9.4. It might be possible to make use of a survey which DG XXIV is about to start in the food field () where there are similar problems.

3.10. Article 11 - Procedure for alternative names

3.10.1. A request to use an alternative name may be tabled only on the basis of Article 11.

3.11. Article 16 - paragraph 2 - Extension of safety data sheets (SDS)

3.11.1. This now requires SDS for preparations not classified as dangerous within the meaning of Articles 5, 6 and 7 but containing an individual concentration of ≥ 1 % by weight (0,2 % in volume for gases) of at least one substance dangerous to health or for which there are Community exposure limits at the workplace.

3.11.2. There are very many such preparations. Establishing and updating full data sheets is costly and entails a great deal of paperwork, both for the producers and for the enforcement authorities. Among the producers, SMEs have particular difficulties because often they do not have the necessary technical or human resources.

3.11.3. Full data sheets are justified in those cases where one substance has exposure limits at the workplace (second indent of Article 16, paragraph 2).

3.11.4. In the cases where one component substance poses health hazards (first indent of Article 16, paragraph

2), establishing full data sheets is not normally justified by the benefits. For these preparations, therefore, there should be simplified information sheets giving only those details which are really needed for users or consumers. This is in line with the third paragraph of the introduction to the Annex to Directive 93/112/EC () on the specific information system for dangerous preparations (properties of no significance).

3.11.5. The details for such information sheets could well be incorporated in this proposal so as to ensure that all Member States work on the same basis.

3.12. Article 23

3.12.1. This proposal is under Article 100A, which is a very lengthy and complicated procedure. Predetermined dates of application therefore are unrealistic.

3.12.2. Application therefore should start from the date of actual publication in the OJ with a five-year transition period thereafter in line with the Explanatory Memorandum.

3.13. Annex V - C.1 - Additional labelling of certain sensitizers

3.13.1. The proposal requires that the name of certain sensitizing substances present below the classification concentration be however put on the label with the inscription: 'Contains name of sensitizing substance. May produce an allergic reaction in persons already sensitized`.

3.13.2. Putting the name on the label is a sensible requirement to alert sensitized persons.

3.14. Annex VI - Part A (A) first indent

3.14.1. Replace in the EN/IT/NL/GR/FI versions 'R23` with 'R22`. The former (toxic when inhaled) relates to toxicity, whilst the latter (harmful when ingested) relates to harmfulness.

Brussels, 20 March 1997.

The President of the Economic and Social Committee

Tom JENKINS

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