Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending, for the twenty-ninth time, Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (substances classified as carcinogen, mutagen or toxic to reproduction - c/m/r)

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. INTRODUCTION AND CONTEXT

European Parliament and Council Directive 94/60/EC amending for the fourteenth time Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations [1] introduced a list of substances classified as category 1 or 2 carcinogen, mutagen or toxic to reproduction (c/m/r) in the Appendix of Annex I to Directive 76/769/EEC. It stipulates in points 29, 30 and 31 of Annex I of Directive 76/769/EEC that these substances may not be used in substances or preparations placed on the market for sale to the general public. These are substances which have previously been listed as carcinogen, mutagen or toxic to reproduction (c/m/r) in Annex I of Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances [2]. Annex I of Directive 67/548/EEC is regularly updated by way of adaptations to technical progress.

[1] OJ L 365, 31.12.1994, p. 1.

[2] OJ L 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1).

Directive 94/60/EC also provides that the Commission will submit to the European Parliament and Council, no later than six months after publication of an adaptation to technical progress of Annex I to Council Directive 67/548/EEC, a proposal for a Directive governing the substances newly classified as carcinogenic, mutagenic and toxic to reproduction in categories 1 and 2, so as to update the Appendix of Annex I to Directive 76/769/EEC.

Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the twenty-ninth time Council Directive 67/548/EEC [3], and more particularly Annex I thereto, inserted 146 entries containing substances newly classified as carcinogenic category 1, 21 entries containing substances newly classified as carcinogenic category 2, 152 entries containing substances newly classified as mutagenic category 2, and 24 entries containing substances newly classified as toxic to reproduction category 2 in Annex I of Directive 67/548/EEC. It is proposed to update the Appendix of Annex I to Directive 76/769/EEC in order to govern these substances newly classified in the framework of Directive 67/548/EEC.

[3] OJ L 152, 30.04.2004, p. 1.

This twenty-ninth amendment will insert 346 entries containing substances newly classified or re-classified under Commission Directive 2004/73/EC in the Appendix of Annex I to Directive 76/769/EEC. However, among these 346 entries, 304 contain substances which were already subject to a restriction for sale to the general public due to an earlier classification as c/m/r substance of category 1 or 2. Therefore, only 42 of these entries relate to substances that will be subject for the first time to the restriction for sale to the general public provided in points 29, 30 and 31 of Annex I of Directive 76/769/EEC.

Among the 146 entries containing substances newly classified as carcinogenic category 1, 145 cover substances which were previously classified as carcinogenic category 2. Therefore, the list relating to carcinogens category 2 needs to be amended accordingly.

In addition, a number of entries in the Appendix of Annex I to Directive 76/769/EEC need to be amended to update the content of the column entitled "Notes". This update concerns four entries related to substances classified as carcinogenic category 1, 36 entries related to substances classified as carcinogen category 2, six entries related to substances classified as mutagen category 2, two entries related to substances classified as toxic to reproduction category 1 and three entries related to substances classified as toxic to reproduction category 2.

2. JUSTIFICATION FOR PROPOSAL AND CONSIDERATIONS OF SUBSIDIARITY

What are the objectives of the proposal in relation to the Community's obligations?

Within the framework for action in the field of public health, the European Parliament and the Council have adopted an action plan to combat cancer (Decision No 646/1996/EC [4] and Decision No 1786/2002/EC [5]). In this context, the Community is committed to promoting and improving health, preventing disease, and countering potential threats to health, with a view to reducing avoidable morbidity and premature mortality and activity-impairing disability. Due to the fact that use by consumers of substances classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2 cannot be controlled, safety can only be ensured by governing these substances through restrictions on the placing on the market of substances and preparations containing c/m/r substances.

[4] Decision No 646/96/EC of the European Parliament and of the Council of 29 March 1996 adopting an action plan to combat cancer within the framework for action in the field of public health (1996 to 2000) (OJ L 95, 16.4.1996, p. 9), as amended by Decision No 521/2001/EC (OJ L 79, 17.3.2001, p. 1), which extended the action plan until end 2002.

[5] Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008) (OJ L 271, 9.10.2002, p. 1).

Following the adoption of Directive 94/60/EC the Commission is invited to propose directives restricting the use by the general public of substances newly classified as c/m/r categories 1 or 2.

The aim of the proposal is to preserve the Internal Market. When Member States adopt national provisions restricting the marketing and use of dangerous substances and preparations, including c/m/r substances and preparations, there will be obstacles to trade because of differences in legislation between Member States. This Proposal aims to improve the conditions for the functioning of the Internal Market to the benefit of the protection of the health and safety of consumers.

Do the initiatives arise out of an exclusive Community competence or a shared competence?

The action to preserve the Internal Market for dangerous substances and preparations falls within the exclusive competence of the Community. This competence was established by Council Directive 76/769/EEC.

What are the courses of action available to the Community?

The only course of action available is to put forward a proposal for an amendment to Directive 76/769/EEC, the twenty-ninth amendment, providing for harmonised rules governing the use of substances classified as c/m/r categories 1 or 2 by restricting the placing on the market for sale to the general public of substances or preparations containing such c/m/r substances.

Are uniform rules necessary? Is it not sufficient to establish targets to be implemented by Member States?

The proposed twenty-ninth amendment establishes uniform rules for the use of substances newly classified as c/m/r category 1 or 2 by restricting the placing on the market for sale to the general public of substances or preparations containing such c/m/r substances. It therefore guarantees a high level of protection of health and safety of consumers. The proposed twenty-ninth amendment is the only way to meet these goals. Targets would be insufficient.

3. RATIONALE OF THE PROPOSAL

The proposed twenty-ninth amendment would govern the substances newly classified or re-classified as c/m/r category 1 or category 2 in the twenty-ninth adaptation to technical progress of Directive 67/548/EEC by inserting them in the Appendix of Annex I to Directive 76/769/EEC in order to restrict their use in substances and preparations placed on the market for sale to the general public.

4. COSTS AND BENEFITS

4.1. Costs

Concerning the substances newly classified as carcinogen, mutagen or toxic to reproduction of category 1 or 2 in the twenty-ninth adaptation to technical progress of Directive 67/548/EEC, the costs are estimated to be low due to the limited use of those substances by the general public. According to available information, a large number of these newly classified c/m/r substances are used as raw material, organic synthesis intermediates or for specific professional applications.

In addition, most of the substances listed in the proposed twenty-ninth amendment were already subject to a restriction for sale to the general public due to their previous classification as a c/m/r substance of category 1 or 2 and are just been subject to reclassification or have been ascribed new notes. In practice, only 42 of the 346 entries containing substances newly classified will relate to substances that will be subject to new restrictions for sale to the general public.

The proposal is cost-effective since it will ensure that consumer health is protected more effectively without having any significant impact in economic terms and in terms of job losses, given that use of these dangerous substances by the general public is limited.

4.2. Benefits

Concerning the 42 entries containing substances newly classified as carcinogen, mutagen or toxic to reproduction, the proposed restriction for sale to the general public will ensure that the substances classified as carcinogenic, mutagenic and toxic to reproduction of categories 1 and 2 are not used in substances and preparations placed on the market for sale to the general public. The benefit of the proposal is an increased level of protection for consumers.

5. PROPORTIONALITY

Directive 94/60/EEC provides that the proposal from the Commission for a Directive governing the substances newly classified as carcinogenic, mutagenic and toxic to reproduction in categories 1 and 2 will take account of the risks and advantages of the substances newly classified as well as of the Community legislative provisions on risk analysis.

In the elaboration of this proposal, the Commission has sought all available information concerning the uses of these substances covered in order to find the right balance. In this context, it should be recalled that most of these substances were already subject to a restriction for sale to the general public due to their previous classification as a c/m/r substance of category 1 or 2 and are just been subject to a re-classification or have been ascribed new notes. Therefore, the present proposal does not have any impact.

Concerning the remaining substances (contained in 42 of the 346 entries) which were not previously subject to the restriction for use in substances and preparations placed on the market for sale to the general public established in points 29, 30 and 31 of Annex I of Directive 76/769/EEC, according to the available information and the outcome of the consultation of stakeholders, it appears that a large number of these substances are used as raw material, organic synthesis intermediates or for specific professional applications rather than in substances and preparations placed on the market for sale to the general public and that there is no need for specific derogation in the present proposal.

Therefore, the twenty-ninth amendment would yield benefits in terms of protecting human health and the environment. This will be achieved at low cost.

6. CONSULTATIONS PERFORMED IN PREPARING THE DRAFT twenty-ninth AMENDMENT

A number of organisations have been consulted, inter alia CEFIC (European Chemical Industry Council), the CONCAWE (Conservation of Clean Air and Water in Europe), Eurometaux (European association of metals) and BLIC (European association of the rubber industry) as well as the European Consumer's organisation (BEUC). The experts from Member States were consulted on 15 July 2004.

7. CONFORMITY WITH THE TREATY

This proposal is intended to preserve the Internal Market and at the same time ensure a high level of protection of health of the consumers and of the environment and is therefore in conformity with Article 95(3) of the Treaty.

8. EUROPEAN PARLIAMENT AND ECONOMIC AND SOCIAL COMMITTEE

In compliance with Article 95 of the Treaty, the co-decision procedure with the European Parliament is applicable. The Economic and Social Committee has to be consulted.

2004/0225 (COD)

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending, for the twenty-ninth time, Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (substances classified as carcinogen, mutagen or toxic to reproduction - c/m/r) (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission [6],

[6] OJ C [...], [...], p. [...].

Having regard to the opinion of the European Economic and Social Committee [7],

[7] OJ C [...], [...], p. [...].

Acting in accordance with the procedure laid down in Article 251 of the Treaty [8],

[8] OJ C [...], [...], p. [...].

Whereas:

(1) The measures provided for in this Directive fall within the framework of the action plan adopted in Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008) [9]. According to this decision the Community is committed to promoting and improving health, preventing disease, and countering potential threats to health, with a view to reducing avoidable morbidity and premature mortality and activity-impairing disability.

[9] OJ L 271, 9.10.2002, p. 1. Decision as amended by Decision No 786/2004/EC (OJ L 138, 30.4.2004, p. 7).

(2) The substances which appear in Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances [10] and are classified as carcinogens category 1 or 2 may cause cancer. The substances which appear in Annex I to Directive 67/548/EEC and are classified as mutagens category 1 or 2 may cause heritable genetic damages. The substances which appear in Annex I to Directive 67/548/EEC and are classified as toxic to reproduction category 1 or 2 may cause birth defects or may impair fertility.

[10] OJ L 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1).

(3) In order to improve human health protection and consumer safety, the use of substances newly classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2 should be governed and the placing on the market of substances and preparations containing them should be subject to restriction for sale to the general public.

(4) Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations [11] lays down restrictions on the marketing and use of certain dangerous substances and preparations, with the objective, among others, to improve human health protection and consumer safety.

[11] OJ L 262, 27.9.1976, p. 201.

(5) Directive 94/60/EC of the European Parliament and of the Council of 20 December 1994 amending for the 14th time Directive 76/769/EEC [12] establishes, in the form of an Appendix of Annex I to Directive 76/769/EEC, a list containing substances classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2. Such substances and preparations containing them should be subject to restriction for sale to the general public.

[12] OJ L 365, 31.12.1994, p. 1.

(6) Directive 94/60/EC provides that the Commission will submit to the European Parliament and Council, no later than six months after publication in the Official Journal of the European Union of an adaptation to technical progress of Annex I to Council Directive 67/548/EEC, which contains substances classified as carcinogenic, mutagenic or toxic to reproduction in category 1 or 2, a proposal for a directive governing these newly classified substances, so as to update the Appendix of Annex I to Directive 76/769/EEC. Such proposal from the Commission will take account of the risks and advantages of the newly classified substances as well as of the Community legislative provisions on risk analysis.

(7) Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the twenty-ninth time Council Directive 67/548/EEC [13], and more particularly Annex I thereto, includes 146 entries containing substances newly classified as carcinogenic category 1, 21 entries containing substances newly classified as carcinogenic category 2, 152 entries containing substances newly classified as mutagenic category 2 and 24 entries containing substances newly classified as toxic to reproduction category 2.

[13] OJ L 152, 30.4.2004, p. 1.

(8) Commission Directive 2004/73/EC also amends the notes relating to the identification, classification and labelling ascribed to four substances classified as carcinogenic category 1, 36 entries containing substances classified as carcinogenic category 2, six entries containing substances classified as mutagenic category 2, two entries containing substances classified as toxic to reproduction category 1 and three entries containing substances classified as toxic to reproduction category 2. The lists in the Appendix of Annex I to Directive 76/769/EEC should be amended accordingly.

(9) The risks and advantages of the newly classified substances, by Directive 2004/73/EC, as carcinogenic, mutagenic and toxic to reproduction of category 1 or 2 have been taken into account, in particular those relating to the substances which were not yet subject to a restriction for use in substances and preparations placed on the market for sale to the general public (due to an earlier classification). This analysis concluded that these newly classified substances could be inserted in the Appendix of Annex I to Directive 76/769/EEC.

(10) This Directive should apply without prejudice to Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work [14], and individual directives based thereon, in particular Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work [15].

[14] OJ L 183, 29.6.1989, p. 1.

[15] OJ L 196, 26.7.1990, p. 1. Directive as last amended by Council Directive 1999/38/EC (OJ L 138, 1.6.1999, p. 66).

HAVE ADOPTED THIS DIRECTIVE:

Article 1

The Appendix of Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive.

Article 2

1. Member States shall adopt and publish, by [ [16]] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

[16] [twelve months after the date of entry into force of this Directive].

They shall apply those provisions from [ [17]]

[17] [eighteen months after the date of entry into force of this Directive].

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the [...] day following that of its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, [...]

For the European Parliament For the Council

The President The President

ANNEX

1. The heading "Notes" of the Foreword is amended as follows:

(a) The following notes are inserted:

"Note A:

The name of the substance must appear on the label in the form of one of the designations given in Annex I of Directive 67/548/EEC (see Article 23(2)(a)).

In Annex I of Directive 67/548/EEC, use is sometimes made of a general description such as '...compounds' or '...salts'. In this case, the manufacturer or any other person who markets such a substance is required to state on the label the correct name, due account being taken of the chapter entitled 'Nomenclature' of the Foreword.

Directive 67/548/EEC also requires that the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in Annex I (Article 23(2)(c), (d) and (e)).

For substances belonging to one particular group of substances included in Annex I of Directive 67/548/EEC, the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in the appropriate entry in that Annex I.

For substances belonging to more than one group of substances included in Annex I of Directive 67/548/EEC, the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in both the appropriate entries given in Annex I. In cases where two different classifications are given in the two entries for the same hazard, the classification reflecting the more severe hazard classification is used."

"Note D:

Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in Annex I to Directive 67/548/EEC.

However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the manufacturer or any person who places such a substance on the market must state on the label the name of the substance followed by the words 'non-stabilised'."

"Note E:

Substances with specific effects on human health (see chapter 4 of Annex VI of Directive 67/548/EEC) that are classified as carcinogenic, mutagenic and/or toxic for reproduction in categories 1 or 2 are ascribed Note E if they are also classified as very toxic (T+), toxic (T) or harmful (Xn). For these substances, the risk phrases R20, R21, R22, R23, R24, R25, R26, R27, R28, R39, R68 (harmful), R48 and R65 and all combinations of these risk phrases shall be preceded by the word 'Also'."

"Note H:

The classification and label shown for this substance applies to the dangerous property(ies) indicated by the risk phrase(s) in combination with the category(ies) of danger shown. The requirements of Article 6 of Directive 67/548/EEC on manufacturers, distributors, and importers of this substance apply to all other aspects of classification and labelling. The final label shall follow the requirements of section 7 of Annex VI of Directive 67/548/EEC.

This note applies to certain coal- and oil-derived substances and to certain entries for groups of substances in Annex I of Directive 67/548/EEC."

"Note S:

This substance may not require a label according to Article 23 of Directive 67/548/EEC (see section 8 of Annex VI)."

(b) Note K is replaced by the following text:

"Note K:

The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0.1% w/w 1,3-butadiene (Einecs No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the S-phrases (2-)9-16 should apply. This note applies to certain complex oil-derived substances in Annex I to Directive 67/548/EEC."

2. The list under heading "Point 29 - Carcinogens: category 1" is amended as follows:

(a) The following entries are inserted:

>TABLE POSITION>

(b) The entries with index numbers 024-001-00-0, 601-020-00-8, 612-022-00-3 and 612-042-00-2 are replaced by the following:

>TABLE POSITION>

3. The list under heading "Point 29 - Carcinogens: category 2" is amended as follows:

(a) The following entries are inserted:

>TABLE POSITION>

(b) The entries with index numbers 007-008-00-3, 007-013-00-0, 016-023-00-4, 024-002-00-6, 024-003-00-1, 024-004-00-7, 024-004-01-4, 027-004-00-5, 027-005-00-0, 048-002-00-0, 048-006-00-2, 048-008-00-3, 048-009-00-9, 602-010-00-6, 602-073-00-X, 603-063-00-8, 605-020-00-9, 608-003-00-4, 609-007-00-9, 609-049-00-8, 611-001-00-6, 611-063-00-4, 612-035-00-4, 612-051-00-1, 612-077-00-3, 613-033-00-6, 648-043-00-X, 648-080-00-1, 648-100-00-9, 648-102-00-X, 648-138-00-6, 649-001-00-3, 649-002-00-9, 649-003-00-4, 649-004-00-X, 649-005-00-5 and 649-006-00-0 are replaced by the following:

>TABLE POSITION>

(c) In the entry with index number 611-063-00-4, the number "164058-22-4" is inserted in the column entitled "CAS number".

d) The entries with index numbers 649-062-00-6, 649-063-00-1, 649-064-00-7, 649-065-00-2, 649-066-00-8, 649-067-00-3, 649-068-00-9, 649-069-00-4, 649-070-00-X, 649-071-00-5, 649-072-00-0, 649-073-00-6, 649-074-00-1, 649-075-00-7, 649-076-00-2, 649-077-00-8, 649-078-00-3, 649-079-00-9, 649-080-00-4, 649-081-00-X, 649-082-00-5, 649-083-00-0, 649-084-00-6, 649-085-00-1, 649-086-00-7, 649-087-00-2, 649-089-00-3, 649-090-00-9, 649-091-00-4, 649-092-00-X, 649-093-00-5, 649-094-00-0, 649-095-00-6, 649-096-00-1, 649-097-00-7, 649-098-00-2, 649-099-00-8, 649-100-00-1, 649-101-00-7, 649-102-00-2, 649-103-00-8, 649-104-00-3, 649-105-00-9, 649-106-00-4, 649-107-00-X, 649-108-00-5, 649-109-00-0, 649-110-00-6, 649-111-00-1, 649-112-00-7, 649-113-00-2, 649-114-00-8, 649-115-00-3, 649-116-00-9, 649-117-00-4, 649-120-00-0, 649-121-00-6, 649-122-00-1, 649-123-00-7, 649-124-00-2, 649-125-00-8, 649-126-00-3, 649-127-00-9, 649-128-00-4, 649-129-00-X, 649-130-00-5, 649-131-00-0, 649-132-00-6, 649-133-00-1, 649-134-00-7, 649-135-00-2, 649-136-00-8, 649-137-00-3, 649-138-00-9, 649-139-00-4, 649-140-00-X, 649-141-00-5, 649-142-00-0, 649-143-00-6, 649-144-00-1, 649-145-00-7, 649-146-00-2, 649-147-00-8, 649-148-00-3, 649-149-00-9, 649-150-00-4, 649-151-0-X, 649-152-00-5, 649-153-00-0, 649-154-00-6, 649-155-00-1, 649-156-00-7, 649-157-00-2, 649-158-00-8, 649-159-00-3, 649-160-00-9, 649-161-00-4, 649-162-00-X, 649-163-00-5, 649-164-00-0, 649-165-00-6, 649-166-00-1, 649-167-00-7, 649-168-00-2, 649-169-00-8, 649-170-00-3, 649-171-00-9, 649-172-00-4, 649-173-00-X, 649-174-00-5, 649-177-00-1, 649-178-00-7, 649-179-00-2, 649-180-00-8, 649-181-00-3, 649-182-00-9, 649-183-00-4, 649-184-00-X, 649-185-00-5, 649-186-00-0, 649-187-00-6, 649-188-00-1, 649-189-00-7, 649-190-00-2, 649-191-00-8, 649-193-00-9, 649-194-00-4, 649-195-00-X, 649-196-00-5, 649-197-00-0, 649-198-00-6, 649-199-00-1, 649-199 -00-5, 649-200-00-5, 649-201-00-0, 649-202-00-6, 649-203-00-1, 649-204-00-7, 649-205-00-2, 649-206-00-8, 649-207-00-3, 649-208-00-9, 649-209-00-4 and 649-210-00-X are deleted.

4. The list under heading "Point 30 - Mutagens: category 2" is amended as follows:

(a) The following entries are inserted:

>TABLE POSITION>

(b) The entries with index numbers 024-002-00-6, 024-003-00-1, 024-004-00-7, 024-004-01-4, 048-006-00-2 and 048-008-00-3 are replaced by the following:

>TABLE POSITION>

5. In the list under heading "Point 31 - Toxic to reproduction: category 1", the entries with index numbers 082-001-00-6 and 082-002-00-1 are replaced by the following:

>TABLE POSITION>

6. The list under heading "Point 31 - Toxic to reproduction: category 2" is amended as follows:

(a) The following entries are inserted:

>TABLE POSITION>

(b) The entries with index numbers 048-006-00-2, 048-008-00-3 and 603-063-00-8 are replaced by the following:

>TABLE POSITION>