S.I. No. 393/2000 - European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations, 2000

These substances are classified in Annex I or shall be classified in accordance with Article 6 of Directive 67/548/EEC. However, some of these substances, although classified in accordance with Article 2 Of Directive 67/548/EEC do not present a danger to human health by inhalation, ingestion or contact with skin or to the aquatic environment in the form in which they are placed on the market. Such substances do not require a label according to Article 23 of Directive 67/548/EEC. However, all the information which should have appeared on the label shall be transmitted to the user by the person responsible for placing the metal on the market, in a format foreseen in Article 30 of Directive 67/548/EEC.

8.4. Substances classified with R65

Substances classified as harmful on the basis of an aspiration hazard need not be labelled as harmful with R65 when placed on the market in aerosol containers or in containers fitted with a sealed spray attachment.

9 SPECIAL CASES: PREPARATIONS

9.1. Gaseous preparations (gas mixtures)

For gaseous preparations, consideration must be given to:

• the evaluation of the physico-chemical properties,

• the evaluation of health hazards.

9.1.1. Evaluation of physico-chemical properties

9.1.1.1. Flammability

The flammable properties of these preparations are determined in accordance with Article 3(2) of Directive 88/379/EEC according to the methods specified in Part A of Annex V to Directive 67/548/EEC.

These preparations will be classified according to the results of the tests carried out and with respect to the criteria of Annex V and to the criteria of the labelling guide.

However, by derogation, in the case where gaseous preparations are produced to order in small amounts, the flammability of these gaseous mixtures can be evaluated by the following calculation method:

the expression of the gaseous mixture

AlFl + … + AiFi + … AnFn + … + BiIi + … + BpIi + … BpIp

where: Ai and Bi are the molar fractions

Fi flammable gas

Ii inert gas

n number of flammable gases

p number of inert gases

can be transformed in a form where all the Ii (inert gases) are expressed by a nitrogen equivalent using a coefficient Ki and where the equivalent content of inflammable gas A'i is expressed as follows:

A'i=Ai x ( 100/ (Ai+KiBi))

By using the value of the maximum content of flammable gas which, in a mixture with nitrogen, gives a composition which is not flammable in air (Tci), the following expression can be obtained:

Σi A'i/ Tci ≤ 1

The gas mixture is flammable if the value of the above expression is greater than one. The preparation is classified extremely flammable and, the phrase R12 is assigned.

Coefficients of equivalency (Ki)

The values of the coefficients of equivalency Ki, between the inert gases and nitrogen and the values of the maximum contents of flammable gas (Tci) may be found in tables 1 and 2 of the ISO Standard ISO 10156 edition 15. 12. 1990

Maximum content of flammable gas (Tci)

The value of the maximum content of flammable gas (Tci) may be found in table 2 of the ISO Standard ISO 10156 edition 15. 12. 1990

When a Tci value for a flammable gas does not appear in the above standard, the corresponding lower explosivity limit (LEL) will be used. If no LEL value exists, the value of Tci will be set at 1 % by volume.

Remarks

• The expression above can be used to allow an appropriate labelling of gaseous preparations, however, it should not be regarded as a method for replacing experimentation for the determination of technical safety parameters.

• Furthermore, this expression gives no information as to whether a mixture containing oxidizing gases can be prepared safely. When estimating flammability these oxidizing gases a are not taken into account.

• The expression above will give reliable results only if the flammable gases do not influence each other as far as their flammability is concerned. This has to be considered, e.g. with halogenated hydrocarbons.

9.1.1.2. Oxidizing properties

Given the fact that Annex V to Directive 67/548/EEC does not contain a method to determine the oxidizing properties of gaseous mixtures, the evaluation of these properties must be realised according to the following estimation method.

The principle of the method is comparison of the oxidizing potential of gases in a mixture with that of the oxidizing potential of oxygen in air. The concentrations of gases in the mixture are expressed in % vol.

It is considered that the gas mixture is as oxidant as or more oxidant than air, if the following condition is verified:

Σi Xi Ci≥ 21

where: xi is the concentration of gas i in % vol,

Ci is the coefficient of oxygen equivalency.

In this case, the preparation is classified as oxidizing and the phrase R8 will be assigned.

Coefficients of equivalency between oxidizing gases and oxygen

The coefficients used in the calculation to determine the oxidizing capacity of certain gases in a mixture with respect to the oxidizing capacity of oxygen in air, listed under 5.2. in the ISO Standard ISO 10156 edition 15. 12. 1990, are the following.

O2 1

N2O 0,6

When no value for the Ci coefficient exists for a gas in the cited standard a value of 40 is attributed to this coefficient.

9.1.2. Evaluation of the health effects

This evaluation of the dangers of a preparation for health is made according to Article 3(3) of Directive 88/379/EEC.

When the evaluation of the health hazards is made according to the conventional method described in Article 3(5) of Directive 88/379/EEC by reference to individual concentration limits, the individual concentration limits to be used are expressed in percent by volume and appear:

• either in Annex I to Directive 67/548/EEC for the gas (es) considered,

• or in Annex I to Directive 88/379/EEC, tables IA to VIA when the gas (es) considered are not in Annex I, or appear there without concentration limits.

9.1.3. Labelling

For mobile gas containers the requirements concerning labelling are considered to be satisfied when they are in agreement with Article 8(5) (b) of Directive 88/379/EEC.

However, by way of derogation from Articles 8(1). and 8(2)., for gas containers with a water capacity of less than or equal to 150 litres, the format and dimensions of the label can follow the prescriptions of the ISO Standard 7225. In this case, the label can bear the generic name or industrial/commercial name of the preparation provided that the dangerous component substances of the preparation are shown on the body of the gas cylinder in a clear and indelible way. The information specified in Article 7 may be provided on a durable information disc or label held captive on the containers.

9.2 Gas containers intended for preparations containing stenched propane, butane or liquefied petroleum gas (LPG)

Propane, butane and liquefied petroleum gas are classified in Annex I. Although preparations containing these substances are classified in accordance with Article 3 of Directive 88/379/EEC, they do not present a danger to human health when they are placed on the market in closed refillable cylinders or in non-refillable cartridges within the scope on EN417 as fuel gases which are only released for combustion. These cylinders and cartridges must be labelled with the appropriate symbol and the R- and S-phrases concerning flammability. No information concerning effects on human health is required on the label. However, the information concerning the effects on human health which should have appeared on the label shall be transmitted to the professional user by the person responsible for placing the substance on the market in the format foreseen in Article 10 of Directive 88/379/EEC. For the consumer, sufficient information shall be transmitted to enable them to take all the necessary measures for health and safety as foreseen in Article I paragraph 3 of Directive 91/55/EEC.

9.3 Alloys, preparations containing polymers, preparations containing elastomers

These preparations shall be classified according to the requirements of Articles 3 and labelled according to the requirements of Article 7 of Directive 88/379/EEC.

However some of these preparations although classified in accordance with Articles 3(3) do not present a danger to human health by inhalation, ingestion or contact with the skin or to the aquatic environment in the form in which they are placed on the market. Such preparations do not require a label according to Article 7. However, all the information which would have appeared on the label shall be transmitted to the professional user by means of an information system in a format foreseen in Article 10 of the above-mentioned Directive.

9.4 Preparations classified with R65

Preparations classified as harmful on the basis of an aspiration hazard need not be labelled as harmful with R65 when placed on the market in aerosol containers or in containers with a sealed spray attachment.

9.5 Organic peroxides

Organic peroxides combine the properties of an oxidizer and a combustible substance in one molecule: when an organic peroxide decomposes, the oxidizing part of the molecule reacts exothermically with the combustible (oxidisable) part. For the oxidizing properties the existing methods in Annex V cannot be applied to the organic peroxides.

The following calculation method based on the presence of active oxygen must be used.

The available oxygen content (%) of an organic peroxide preparation is given by the formula:

16 x (ni x ci/mi)

where:

ni=number of peroxygen groups per molecule of organic peroxide i,

ci=concentration (mass %) of organic peroxide i,

mi=molecular mass of organic peroxide i.

SCHEDULE 5 ANNEX VII. A

INFORMATION REQUIRED FOR THE TECHNICAL DOSSIER (“BASE SET”) REFERRED TO IN ARTICLE 7 (1)

If it is not technically possible or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated and be subject to acceptance by the competent authority.

The name of the body or bodies responsible for carrying out the studies shall be mentioned.

For substances manufactured outside the Community and for which, for the purpose of notification, the notifier has been designated as the manufacturer's sole representative, the identity and the addresses of the importers who will be bringing the substance into the Community.

1.1 Name

1.1.1. Names in the IUPAC nomenclature

1.1.2 Other names (usual name, trade name, abbreviation)

1.1.3 CAS number and CAS name (if available)

1.2. Molecular and structural formula

1.3. Composition of the substance

1.3.1 Degree of purity (%)

1.3.2 Nature of impurities, including isomers and by-products

1.3.3 Percentage of (significant) main impurities

1.3.4 If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude: ................ ppm, ................ %

1.3.5 Spectral data (UV, IR, NMR or mass spectrum)

1.3.6 HPLC, GC

1.4 Methods of detection and determination

A full description of the methods used or the appropriate bibliographical references

Apart from methods of detection and determination, information shall be given on analytical methods which are known to the notifier and allows detection of a substance and its transformation products after discharge into the environment as well as determination of the direct exposure of humans.

2 INFORMATION ON THE SUBSTANCE

2.0. Production

Information given in the section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure associated with the production process. Precise details of the production process, particularly those of a commercially sensitive nature, are not required.

2.0.1. Technological process used in production

2.0.2. Exposure estimates related to production:

• working environment

• environment

2.1. Proposed uses

Information given in this section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure to the substances as associated with the proposed/expected uses.

2.1.1. Types of use: description of the function and the desired effects

2.1.1.1 Technological process (es) related to the use of the substance (where known)

2.1.1.2. Exposure estimate(s) related to use (where known):

• working environment

• environment

2.1.1.3. Form under which the substance is marketed: substance, preparation, product

2.1.1.4. Concentration of the substance in marketing preparations and products (where known)

2.1.2. Fields of application with approximate breakdown:

• industries

• farmers and skilled trades

• use by the public at large

2.1.3. Where known and where appropriate, the identity of the recipients of the substance

2.1.4. Waste quantities and composition of waste resulting from the proposed uses (where known)

2.2. Estimated production and/or imports for each of the anticipated uses or fields of application

2.2.1. Overall production and/or imports in tonnes per year:

• the first calendar year

• the following calendar years

For the substances manufactured outside the Community and for which, for the purpose of notification, the notifier has been designated as the manufacturer's sole representative, this information must be given for each of the importers identified under section 0 above.

2.2.2. Production and/or imports, broken down in accordance with 2.1.1 and 2.1.2 expressed as a percentage:

• the first calendar year

• the following calendar years

2.3. Recommended methods and precautions concerning:

2.3.1. Handling

2.3.2. Storage

2.3.3. Transport

2.3.4. Fire (nature of combustion gases or pyrolysis, where proposed uses justify this)

2.3.5. Other dangers, particularly chemical reaction with water

2.3.6. If relevant, information concerning the susceptibility of the substance to explode when presented in the form of a dust

2.4. Emergency measures in the case of accidental spillage

2.5. Emergency measures in the case of injury to persons (e.g. poisoning)

2.6. Packaging

3.0. State of the substance at 20 oC and 101,3 kPA

3.1 Melting-point

3.2 Boiling-point

3.3 Relative density

3.4 Vapour pressure

3.5 3.5. Surface tension

3.6 3.6. Water solubility

3.8. Partition coefficient n/octanol/water

3.9. Flash-point

3.10. Flammability

3.11. Explosive properties

3.12. Self-ignition temperature

3.13. Oxidizing properties

3.15. Granulometry:

For those substances which may be marketed in a form which gives rise to the danger of exposure by the inhalatory route, a test should be conducted to determine the particle size distribution of the substance as it will be marketed.

4.1. Acute toxicity

For tests 4.1.1 to 4.1.3, substances other than gases shall be administered via at least two routes, one of which should be the oral route. The choice of the second route will depend on the nature of the substance and the likely route of human exposure. Gases and volatile liquids should be administered by the inhalation route.

4.1.1. Administered orally

4.1.2. Administered by inhalation

4.1.3. Administered cutaneously

4.1.5 Skin irritation

4.1.6 Eye irritation

4.1.7 Skin sensitization

4.2. Repeated dose

The route of administration should be the most appropriate having regard to the likely route of human exposure, the acute toxicity and the nature of the substance. In the absence of contra-indications the oral route is usually the preferred one.

4.2.1. Repeated dose toxicity (28 days)

4.3. Other effects

4.3.1. Mutagenicity

The substance shall be examined in two tests. One shall be a bacteriological (reverse mutation) test, with and without metabolic activation. The second shall be a non-bacteriological test to detect chromosome aberrations or damage. In the absence of contra-indications, this test should normally be conducted in vitro, both with and without metabolic activation. In the event of a positive result in either test, further testing according to the strategy described in Annex V should be carried out.

4.3.2. Screening for toxicity related to reproduction (for the record)

4.3.3. Assessment of the toxicokinetic behaviour of a substance to the extent that can be derived from base set data and other relevant information

5.1. Effects on organisms

5.1.1. Acute toxicity for fish

5.1.2. Acute toxicity for daphnia

5.1.3. Growth-inhibitor test on algae

5.1.6. Bacterial inhibition in those cases where biodegradation may be affected by the inhibitory effect of a substance on the bacteria, a test for bacterial inhibition should be carried out prior to undertaking the biodegradation.

5.2. Degradation

• biotic

• antibiotic:

If the substance is not readily biodegradable then consideration should be given to the need to carry out the following tests: hydrolysis as a function of pH.

5.3. Absorption/desorption screening test

6.1. For industry/skilled trades

6.1.1. Possibility of recycling

6.1.2. Possibility of neutralization of unfavourable effects

6.1.3. Possibility of destruction:

• controlled discharge

• incineration

• water purification station

• others

6.2. For the public at large

6.2.1. Possibility of recycling

6.2.2. Possibility of neutralization of unfavourable effects

6.2.3. Possibility of destruction:

• controlled discharge

• incineration

• water purification station

• others

ANNEX VII. B

INFORMATION REQUIRED FOR THE TECHNICAL DOSSIER (“BASE SET”) REFERRED TO IN ARTICLE 8 (1) AND (3)

If it is not technically possible or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated and subject to acceptance by the competent authority.

The name of the body or bodies responsible for carrying out the studies shall be mentioned.

In addition to the information requested below, Member States may, if they consider it necessary for the risk assessment, require that the notifier provides the following additional information: - vapour pressure, - daphnia acute toxicity test.

For substances manufactured outside the Community and for which, for the purpose of notification, the notifier has been designated as the manufacturer's sole representative, the identity and the addresses of the importers who will be bringing the substance into the Community

1.1 Name

1.1.1. Names in the IUPAC nomenclature

1.1.2. Other names (usual name, trade name, abbreviation)

1.1.3. CAS number and CAS name (if available)

1.2. Molecular and structural formula

1.3. Composition of the substance

1.3.1. Degree of purity (%)

1.3.2. Nature of impurities including isomers and by-products

1.3.3. Percentage of (significant) main impurities

1.3.4. If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature order of magnitude: ................ ppm, ................ %

1.3.5. Spectral data (UV, IR, NMR or mass spectrum)

1.3.6. HPLC, GC

2.3 Methods of detection and determination

A full description of the methods used or the appropriate bibliographical references Apart from methods of detection and determination, information on analytical methods which are known to the notifier and which allow detection of a substance and its transformation products after discharge into the environment as well as determination of the direct exposure of humans

2.0. Production

Information given in this section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure, associated with the production process. Precise details of the production process, particularly those of a commercially sensitive nature, are not required.

2.0.1. Technological process (es) used in production

2.0.2. Exposure estimate related to production:

• working environment

• environment

2.1. Proposed uses

Information given in this section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure to the substances as associated with the proposed/expected uses.

2.1.1. Types of use: description of the function and the desired effects

2.1.1.1. Technological process (es) related to the use of the substance (where known)

2.1.1.2. Exposure estimate(s) related to the use of the substance (where known):

• working environment

• environment

2.1.1.3. Form under which the substance is marketed: substance, preparation, product

2.1.1.4. Concentration of the substance in marketed preparations and products (where known)

2.1.2. Fields of application with approximate breakdown:

• industries

• farmers and skilled trades

• use by the public at large

2.1.3. Where known and where appropriate, the identity of the recipients of the substance

2.2. Estimated production and/or imports for each of the anticipated uses or fields of application

2.2.1. Overall production and/or imports in tonnes per year:

• first calendar year

• the following calendar years

For substances manufactured outside the Community and for which, for the purposes of notification, the notifier has been designated as the manufacturer's sole representative, this information must be given for each of the importers identified under section 0 above.

2.2.2 Production and/or imports, broken down in accordance with 2.1.1 and 2.1.2 expressed as a percentage:

• the first calendar year

• the following calendar years

2.3 Recommended methods and precautions concerning:

2.3.1. Handling

2.3.2 Storage

2.3.3 Transport

2.3.4 Fire (nature of combustion gases or pyrolysis, where proposed uses justify this)

2.3.5 Other dangers, particularly chemical reaction with water

2.4. Emergency measures in the case of accidental spillage

2.5. Emergency measures in the case of injury to persons (e.g. poisoning)

2.6. Packaging

3.0. State of the substance at 20 oC and 101,3 Kpa

3.1. Melting-point

3.2. Boiling-point

3.6. Water solubility

3.8. Partition coefficient n-octanol/water

3.9. Flash-point

3.10. Flammability

4.1. Acute toxicity

For tests 4.1.1 to 4.1.2 one route of administration is sufficient. Substances other than gases should be tested by oral administration. Gases should be tested by inhalation.

4.1.1. Administered orally

4.1.2. Administered by inhalation

4.1.5. Skin irritation

4.1.6. Eye irritation

4.1.7. Skin sensitization

4.3. Other effects

4.3.1. Mutagenicity: The substance should be examined in a bacteriological (reverse mutation) test with and without metabolic activation.

5.2. Degradation:

Biotic

ANNEX VII. C

INFORMATION REQUIRED FOR THE TECHNICAL DOSSIER (“BASE SET”) REFERRED TO IN ARTICLE 8 (2)

If it is not technically possible or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated and be subject to acceptance by the competent authority.

The name of the body or bodies responsible for carrying out the studies shall be mentioned.

For substances manufactured outside the Community and for which, for the purpose of notification, the notifier has been designated as the manufacturer's sole representative, the identity and the addresses of the importers who will be bringing the substance into the Community

1.1. Name

1.1.1. Names in the IUPAC nomenclature

1.1.2. Other names (usual name, trade name, abbreviation)

1.1.3. CAS number and CAS name (if available)

1.2 Molecular and structural formula

1.3 Composition of the substance

1.3.1. Degree of purity (%)

1.3.2. Nature of impurities, including isomers and by-products

1.3.3. Percentage of (significant) main impurities

1.3.4. If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude: ................ ppm: ................ %

1.3.5. Spectral data (UV, IR, NMR or mass spectrum)

1.3.6. HPLC, GC

1.4. Methods of detection and determination

A full description of the methods used or the appropriate bibliographical references

Apart from methods of detection and determination, information on analytical methods which are known to the notifier and which allow detection of a substance and its transformation products after discharge into the environment as well as determination of the direct exposure of humans

2.0. Production

Information given in this section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure, associated with the production process. Precise details of the production process, particularly those of a commercially sensitive nature, are not required.

2.0.1. Technological process (es) used in production

2.0.2. Exposure estimate related to production:

• working environment

• environment

2.1. Proposed uses

Information given in this section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure to the substances as associated with the proposed/expected uses.

2.1.1. Types of use: description of the function and the desired effects

2.1.1.1. Technological process (es) related to the use of the substance (where known)

2.1.1.2. Exposure estimate(s) related to the use of the substance (where known):

• working environment

• environment

2.1.1.3. Form under which the substance is marketed: - substance, preparation, product

2.1.1.4. Concentration of the substance in marketed preparations and products (where known)

2.1.2. Fields of application with approximate breakdown:

• industries

• farmers and skilled trades

• use by the public at large

2.1.3. Where known and where appropriate, the identity of the recipients of the substance

2.2. Estimated production and/or imports for each of the anticipated uses or fields of application

2.2.1. Overall production and/or imports in tonnes per year:

• the first calendar year

• the following calendar years

For substances manufactured outside the Community and for which, for the purposes of notification the notifier has been designated as the manufacturer's sole representative, this information must be given for each of the importers identified under section 0 above

2.2.2. Production and/or imports, broken down in accordance with 2.1.1 and 2.1.2 expressed as a percentage:

• the first calendar year

• the following calendar years

2.3. Recommended methods and precautions concerning:

2.3.1. Handling

2.3.2. Storage

2.3.3. Transport

2.3.4. Fire (nature of combustion gases or pyrolysis, where proposed uses justify this)

2.3.5. Other dangers, particularly chemical reaction with water

2.4. Emergency measures in the case of accidental spillage

2.5. Emergency measures in the case of injury to persons (e.g. poisoning)

2.6. Packaging

3.0. State of the substance at 20 oC and 101,3 kPa

3.9. Flash-point

3.10. Flammability

4.1. Acute toxicity

One route of administration is sufficient. Substances other than gases should be tested by oral administration. Gases should be tested by inhalation.

4.1.1. Administered orally

4.1.2. Administered by inhalation.

ANNEX VII D

SPECIFIC PROVISIONS CONCERNING THE TECHNICAL DOSSIER (“BASE SET”) CONTAINED IN THE NOTIFICATIONS REFERRED TO IN ARTICLE 12.

A. For the purpose of this Annex

• “homopolymer” is a polymer consisting of only one kind of monomer unit,

• “copolymer” is a polymer consisting of more than one kind of monomer unit,

• “polymer for which a reduced test package is acceptable”,

• “RTP polymer”, is a polymer that satisfies the criteria laid down in C.2,

• “family of polymers” is a group of polymers (either homopolymers or copolymers) with different number-average molecular weights or different compositions resulting from different ratios of monomer units. The difference in the number-average molecular weight or in the composition is determined not by unintentional process-related fluctuations but by deliberate alterations to the process conditions, the process itself remaining the same,

• “Mn” is the number-average molecular weight,

• “M” is the molecular weight,

B. Family approach

To avoid unnecessary testing, the grouping of polymers into families shall be possible. The concept consists of testing representative members of a family with:

• Mn variable for homopolymers, or

• composition variable with Mn approximately constant for copolymers, or

• for Mn > 1 000, Mn variable with composition approximately constant for copolymers.

In certain cases where there are dissimilarities in the effects seen in the representative members, depending on the Mn or composition-range, additional testing of other representative members shall be required.

C. Information required for the technical dossier referred to in Article 12.

If it is not technically possible or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated and be subject to acceptance by the competent authorities.

Appropriate available information on the properties of the monomer(s) may be taken into account for the assessment of the properties of the polymer. Without prejudice to the provisions of Article 3 (1) of Directive 67/548/EEC the tests must be conducted according to methods recognized and recommended by the competent international bodies where such recommendations exist. The name of the body or bodies responsible for carrying out the studies shall be mentioned.

C.1. POLYMERS WITH STANDARD TEST PACKAGE

C.1.1. Polymers placed on the Community market in quantities of >=1 t/a or total quantities of >=5 t

In addition to the information and tests referred to in Article 7 (1), laid down in Annex VII A, the following polymer-specific information is required:

1.2.1. Number-average molecular weight

1.2.2. Molecular weight distribution (MWD)

1.2.3. Identity and concentration of starting monomers and starting substances which will be bound in the polymer

1.2.4. Indication of end groups and identity and frequency of reactive functional groups

1.3.2.1. Identity of non-reacted monomers

1.3.3.1. Percentage of non-reacted monomers

2.1.1.5. Statement, with relevant information, if the polymer has been developed to be environmentally degradable

3.6.1. Water extractivity.

Without prejudice to Article 16 (1) of Directive 67/548/EEC, further tests may be required additionally in certain cases, e.g.:

• light-stability if the polymer is not specifically light-stabilized,

• long-term extractivity (leachate test); depending on the results of this test, appropriate tests on the leachate may be requested on a case by case basis.

C.1.2. Polymers placed on the Community market in quantities of < 1 t/a or total quantities of < 5 t but >=100 kg/a or total quantities >=500 kg

In addition to the information and test referred to in Article 8 (1), laid down in Annex VII B, the following polymer-specific information is required:

1.2.1. Number-average molecular weight

1.2.2. Molecular weight distribution (MWD)

1.2.3. Identity and concentration of starting monomers and starting substances which will be bound in the polymer

1.2.4. Indication of end groups and identity and frequency of reactive functional groups

1.3.2.1. Identity of non-reacted monomers

1.3.3.1. Percentage of non-reacted monomers

2.1.1.5. Statement, with relevant information, if the polymer has been developed to be environmentally degradable

3.6.1. Water extractivity

C.1.3. Polymers placed on the Community market in quantities of < 100 kg/a or total quantities of < 500 kg

In addition to the information and tests referred to in Article 8 (2), laid down in Annex VII C, the following polymer-specific information is required:

1.2.1. Number-average molecular weight

1.2.2. Molecular weight distribution (MWD)

1.2.3. Identity and concentration of starting monomers and starting substances which will be bound in the polymer

1.2.4. Indication of end groups and identity and frequency of reactive functional groups

1.3.2.1. Identity of non-reacted monomers

1.3.3.1. Percentage of non-reacted monomers

2.1.1.5. Statement, with relevant information, if the polymer has been developed to be environmentally degradable

C2. POLYMERS FOR WHICH A REDUCED TEST PACKAGE IS ACCEPTABLE

Under certain conditions the base set test package for polymers can be reduced. Substances with a high number-average molecular weight, a low content of low molecular weight species and a low solubility/extractivity will be regarded as being non-bioavailable. Consequently, the following criteria shall be used to determine the polymers for which a reduced test package is acceptable:

For non-readily degradable polymers placed on the Community market in quantities of ≥ 1 t/a or total quantities of ≥ 5 t, the following criteria define those polymers for which a reduced test package is acceptable:

II. Extractivity in water (3.6.1)

< 10 mg/1 excluding any contribution from additives and impurities;

III. Less than 1 % with M < 1 000; the percentage refers only to molecules (components) directly derived from and including monomer(s), excluding other components e.g. additives or impurities.

If all criteria are fulfilled, the polymer is regarded as a polymer for which a reduced test package is acceptable.

In the case of non-readily degradable polymers placed on the Community market in quantities < 1 t/a or total quantities of < 5 t it is sufficient that criteria I and II are fulfilled for the polymer to be considered a polymer for which a reduced test package is acceptable. If it is not possible to prove the criteria with the assigned tests, the notifier has to demonstrate compliance with the crieria by other means. Under certain circumstances toxicological and ecotoxicological tests may be required.

C.2.1. Polymers placed on the Community market in quantities of >=1 t/a or total quantities of >=5 t

1.1. Name

1.1.1. Name in the IUPAC nomenclature

1.1.2. Other names (usual name, trade name, abbreviation).

1.1.3. CAS number and CAS name if available

1.2. Molecular and structural formula 1.

1.2.1 Number average molecular weight

1.2.2. Molecular weight distribution (MWD)

1.2.3. Identity and concentration of starting monomers and starting substances which will be bound in the polymer

1.2.4. Indication of end groups and identity and frequency of reactive functional groups

1.3. Composition of the substance

1.3.1. Degree of purity (%)

1.3.2. Nature of impurities, including by-products

1.3.2.1. Identity of non-reacted monomers

1.3.3. Percentage of (significant) main impurities

1.3.3.1. Percentage of non-reacted monomers

1.3.4. If the substances contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude: ................ ppm. ................ %1.3.5. Spectral data (UV, IR, NMR or mass spectrum)

1.3.6.1. GPCI.

1.4. Methods of detection and determination

A full description of the methods used or the appropriate bibliographical references. Apart from methods of detection and determination, information shall be given on analytical methods which are known to the notifier and allow detection of a substance and its transformation products after discharge into the environment as well as determination of the direct exposure of humans.

2.0. Production

Information given in the section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure associated with the production process. Precise details of the production process, particularly those of a commercially sensitive nature, are not required.

2.0.1. Technological processed in production.

2.0.2. Exposure estimates related to production:

• working environment

• environment

2.1. Proposed uses

Information given in this section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure to the substances as associated with the proposed/expected uses.

2.1.1. Types of use: description of the function and the desired effect

2.1.1.1. Technological process (es) related to the use of the substance (where known)

2.1.1.2. Exposure estimate(s) related to the use (where known):

• working environment

• environment

2.1.1.3. Form under which the substance is marketed: substance, preparation, product

2.1.1.4. Concentration of the substance in marketing preparations and products (where known)

2.1.2. Fields of application with approximate breakdown:

• industries

• farmers and skilled trades

• use by the public at large

2.1.3. Where known and where appropriate, the identify of the recipients of the substance

2.1.4. Waste quantities and composition of waste resulting from the proposed uses (where known)

2.2. Estimated production and/or imports for each of the anticipated uses or fields of application

2.2.1. Overall production and/or imports in tonnes per year:

• the first calendar year

• the following calendar years

For the substances manufactured outside the Community and for which, for the purpose of notification, the notifier has been designated as the manufacturer's sole representative, this information must be given for each of the importers identified under section O above.

2.2.2. Production and/or imports, broken down in accordance with 2.1.1 and 2.1.2 expressed as a percentage:

• the first calendar year- the following calendar years

2.3. Recommended methods and precautions concerning:

2.3.1. Handling

2.3.2. Storage

2.3.3. Transport

2.3.4. Fire (nature of combustion gases or pyrolysis, where proposed uses justify this)

2.3.5. Other dangers, particularly chemical reaction with water

2.3.6. If relevant, information concerning the susceptibility of the substance to explode when present in the form of a dust2

2.4. Emergency measures in the case of accidental spillage

2.5. Emergency measures in the case of injury to persons (e.g. poisoning)

2.6. Packaging

3.0. State of the substance at 20° C and 101.3 Kpa

3.1 Melting range (e.g. from the thermal stability test)

3.3. Relative density

3.6.1. Water extractivity

3.10. Flammability

3.11. Explosive properties

3.12. Auto-flammability

3.15. Particle size:

For those substances which may be marketed in a form which gives rise to the danger of exposure by the inhalator route, a test should be conducted to determine the particle distribution of the substances as it will be marketed.

3.16. Thermal stability

3.17. Extractivity with:

• water at pH 2 and 9 at 37° C

• cyclohexane

On a case by case basis and without delaying in acceptance of the notification, the competent authorities may, on the basis of the presence of reactive groups, structural/physical characteristics, knowledge concerning the properties of low molecular weight components of the polymer or exposure potential, require certain tests to be carried out. In particular tests for inhalation toxicity (e. g. 4.1.2 or 4.2.1), may be required if exposure by the inhalatory route is considered possible.

On a case-by-case basis and without delaying the acceptance of the notification, the competent authorities may on the basis of the presence of reactive groups, structural/physical characteristics, knowledge concerning the properties of low molecular weight components of the polymer or exposure potential, require certain tests to be carried out. In particular, the following additional tests may be required:

• light-stability, if the polymer is not specifically light-stabilized

• • long-term extextactivity (leachate test). Depending on the results of this test, any appropriate test on the leachate may be requested on a case by case basis

6.1. For industry/skilled trades

6.1.1. Possibility of recycling

6.1.2. Possibility of neutralization of unfavourable effects

6.1.3. Possibility of destruction:

• controlled discharge

• incineration

• water purification station

• others

6.2. For the public at large

6.2.1. Possibility of recycling

6.2.2. Possibility of neutralization of unfavourable effects

6.2.3. Possibility of destruction:

• controlled discharge

• incineration

• water purification station

• others

C.2.2. Polymers placed on the Community market in quantities of < t/a or total quantities of < 5 t

For substances manufactured outside the Community and for which, for the purpose of notification, the notifier has been designated as the manufacturer's sole representative, the identity and the addresses of the importers who will be bringing the substance into the Community.

1.1. Name

1.1.1. Name in the IUPAC nomenclature

1.1.2. Other names (usual name, trade name, abbreviation)

1.1.3. CAS number and CAS name (if available)

1.2. Molecular and structural formula

1.2.1. Number-average molecular weight

1.2.2. Molecular weight distribution (MWD)

1.2.3. Identity and concentration of staring monomers and starting substances which will be bound in the polymer

1.2.4. Indication of end groups and identity and frequency of reactive functional groups

1.3. Composition of the substance

1.3.1. Degree of purity (%)

1.3.2. Nature of impurities, including by-products

1.3.2.1. Identity of non-reacted monomers

1.3.3. Percentage of (significant) main impurities

1.3.3.1. Percentage of non-reacted monomers

1.3.4. If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude: ... ppm, ... %

1.3.5. Spectral data (UV, IR, NMR or mass spectrum)

1.3.6.1. GPC

1.4. Methods of detection and determination

A full description of the methods used or the appropriate bibliographical references. Apart from methods of detection and determination, information shall be given on analytical methods which are known to the notifier and allow detection of a substance and its transformation products after discharge into the environment as well as determination of the direct exposure of humans

2.0. Production

Information given in the section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure associated with the production process. Precise details of the production process, particularly those of a commercially sensitive nature, are not required

2.0.1. Technological process used in production

2.0.2. Exposure estimates related to production:

• working environment

• environment

2.1. Proposed uses

Information given in this section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure to the substances as associated with the proposed/expected uses.

2.1.1. Types of uses: description of the function and the desired effects

2.1.1.1. Technological process (es) related to the use of the substance (where known)

2.1.1.2. Exposure estimate(s) related to the use (where known):

• working environment

• environment

2.1.1.3. Form under which the substance is marketed: substance, preparation, product

2.1.1.4. Concentration of the substance in marketing preparations and products (where known)

2.1.2. Fields of application with approximate breakdown:

• industries

• farmers and skilled trades

• use by the public at large

2.1.3. Where known and where appropriate, the identity of the recipients of the substance

2.1.4. Waste quantities and composition of waste resulting from the proposed uses (where known)

2.2. Estimated production and/or imports for each of the anticipated uses or fields of application

2.2.1. Overall production and/or imports in tonnes per year: - the first calendar year- the following calendar years. For the substances manufactured outside the Community and for which, for the purpose of notification, the notifier has been designated as the manufacturer's sole representative, this information must be given for each of the importers identified under section 0 above.

2.2.2. Production and/or imports, broken down in accordance with 2.1.2 expressed as a percentage:

• the first calendar year

• the following calendar years

2.3. Recommended methods and precautions concerning:

2.3.1. Handling

2.3.2. Storage

2.3.3. Transport

2.3.4. Fire (nature of combustion gases or pyrolysis, where proposed uses justify this)

2.3.5. Other dangers, particularly chemical reaction with water

2.3.6. If relevant, information concerning the susceptibility of the substance to explode when present in the form of a dust

2.4. Emergency measures in the case of accidental spillage

2.5. Emergency measures in the case of injury to persons (e.g. poisoning)

2.6. Packaging

3.0. State of the substance at 20 °C and 101,3 kPa3.1. Melting range (e. f. from the termal stability test)

3.6.1. Water extractivity

3.10. Flammability'

• (1) The authorities receiving the notification shall decide on their own responsibility whether or not a polymer satisfies this criterion.

ANNEX VIII

ADDITIONAL INFORMATION AND TESTS REQUIRED UNDER ARTICLE 7 (2)

If it is not technically possible or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated and be subject to acceptance by the competent authority.

The name of the body or bodies responsible for carrying out the studies shall be indicated.

LEVEL 1

Physico-chemical studies

Further studies on physico-chemical properties dependent upon the results of the studies laid down in Annex VII. Such further studies could include for example the development of analytical methods which make it possible to observe and detect a substance or its transformation products and studies on thermal decomposition products.

Toxicological studies

Fertility study (one species, one generation, male and female, most appropriate route of administration).

If there are equivocal findings in the first generation, study of a second generation is required.

Depending upon the dosing schedule it may be possible in this study to obtain an indication of teratogenicity. A positive indication should be examined in a formal teratology study.

• Teratology study (one species, most appropriate route of administration) This study is required if teratogenicity has not been examined in the fertility study.

• Sub-chronic and/or chronic toxicity study, including special studies (one species, male and female, most appropriate route of administration) shall be required if the results of the repeated-dose study in Annex VII or other relevant information demonstrate the need for further appropriate investigation.

The effects which would indicate the need for such a study could include for example:

• (a) serious or irreversible lesions;

• (b) a very low or absence of a “no effect” level;

• (c) a clear relationship in chemical structure between the substance being studied and other substances which have been proved dangerous.

• Additional mutagenesis studies and/or screening study (ies) for carcinogenesis as prescribed in the testing strategy described in Annex V.

When both tests in the base set are negative, further tests shall be conducted according to the specific properties and the purposed use of the substance.

When a test or both tests were positive in the base set, a supplementary study should include the same or different end points in other in vivo test methods.

• Basic toxicokinetic information.

Ecotoxicity studies

• Prolonged toxicity study with Daphnia magna (21 days)

• Test on higher plants

• Test on earthworms

• Further toxicity studies with fish

• Tests for species accumulation: one species, preferably fish

• Supplementary degradation study (ies), if sufficient degradation has not been proved by the studies laid down in Annex VII- Further studies on absorption/desorption dependent upon the results of the investigations laid down in Annex VII.

LEVEL 2

Toxicological studies

The test programme shall cover the following aspects unless there are strong reasons to the contrary, supported by evidence, that it should not be followed:

• Chronic toxicity study

• Carcinogenicity study

• Fertility study (e.g. three-generation study); only if an effect on fertility has been established at level 1-

• Developmental toxicity study on peri- and postnatal effects

• Teratology study (species not employed in the respective level 1)

• Additional toxicokinetic studies which cover biotransformation, pharmacokinetics

• Additional tests to investigate organ or system toxicity.

Ecotoxicological studies

• Additional tests for accumulation, degradation, mobility and absorption/desorption

• Further toxicity studies with fish

• Toxicity studies with birds-

• Additional toxicity studies with other organisms.'

SCHEDULE 6 ANNEX IX

PART A Provisions relating to child-proof fastenings

In addition to the provisions in Article 22(1)(e) of Directive 67/548/EEC⁴⁸ containers of whatever capacity containing substances presenting an aspiration hazard (Xn; R65) and classified and labelled according to paragraph 3.2.3 of Annex VI to this Directive, with the exception of substances placed on the market in the form of aerosols or in a container fitted with a sealed spray attachment, shall be fitted with child-proof fastenings.

1. Reclosable packages

Child-proof fastenings used on reclosable packages shall comply with ISO standard 8317 (1 July 1989 edition) relating to ‘Child-resistant packages - Requirements and methods of testing for reclosable packages’ adopted by the International Standard Organization (ISO).

2. Non-reclosable packages

Child-proof fastenings used on non-reclosable packages shall comply with CEN standard EN 862 (March 1997 edition) relating to ‘Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products’ adopted by the European Committee for Standardisation (CEN).

3. Notes

If it seems obvious that packaging is sufficiently safe for children because they cannot get access to the contents without the help of a tool, the test does not need to be performed.

In all other cases and when there are sufficient grounds for doubting the security of the closure for a child, the competent authority may ask the person responsible for putting the product on the market to give him a certificate from a laboratory described in 3.1, stating that either:

• the type of closure is such that it is not necessary to test to the ISO and CEN standards referred to above, or

• the closure has been tested and has been found to conform with the standard referred to above.

PART B Provisions relating to tactile warning devices

The technical specifications for tactile warning devices shall conform with EN ISO standard 11683 (1997 edition) relating to “Packaging - Tactile warnings of danger - Requirements”.

SCHEDULE 7

Regulation 22

Obligatory Headings for Safety Data Sheets	Obligatory Headings for Safety Data Sheets
1.	Identification of the substance/preparation and of the company/undertaking;
2.	Composition/information on ingredients;
3.	Hazards identification.
4.	First-aid measures;
5.	Fire-fighting measures;
6.	Accidental release measures;
7.	Handling and storage;
8.	Exposure controls/personal protection;
9.	Physical and chemical properties;
10.	Stability and reactivity;
11.	Toxicological information;
12.	Ecological information;
13.	Disposal considerations;
14.	Transport information;
15.	Regulatory information;
16.	Other information.

SCHEDULE 8 FEES PAYABLE BY NOTIFIER

Regulation 25

	Column 1	Column 1	Column 2
	Subject matter	Subject matter	Fee payable
1.	For a notification under Regulation 10 (1) (“base set”) (See notes 1 and 2)	For a notification under Regulation 10 (1) (“base set”) (See notes 1 and 2)	£5,500
2.	For a re-notification submitted in accordance with Regulation 16 (1) (See notes 1 and 2)	For a re-notification submitted in accordance with Regulation 16 (1) (See notes 1 and 2)	£1,100
3.	For a notification of a substance notified at least 10 years previously (Regulation 12) (See notes 1 and 2)	For a notification of a substance notified at least 10 years previously (Regulation 12) (See notes 1 and 2)	£1,100
4.	For additional tests submitted under Regulation 10(3)(a) (> 10 tonnes per year)	For additional tests submitted under Regulation 10(3)(a) (> 10 tonnes per year)	£3,300
5.	For additional tests submitted under Regulation 10(3)(b) (> 100 tonnes per year)	For additional tests submitted under Regulation 10(3)(b) (> 100 tonnes per year)	£5,500
6.	For additional tests submitted under Regulation 10(3)(c) (> 1000 tonnes per year)	For additional tests submitted under Regulation 10(3)(c) (> 1000 tonnes per year)	£11,000
7.	For a notification under Regulation 11 (see note 3)	For a notification under Regulation 11 (see note 3)
	(a)	quantity of the new substance equal to or more than 100kg (Regulation 11(1))	£1,100
	(b)	quantity of the new substance up to 100kg49 (Regulation 11(3))	£550
8.	For a successful application made by a notifier	For a successful application made by a notifier	£550
	for an exemption relating to him under Regulation 4(14)	for an exemption relating to him under Regulation 4(14)
Note 1. Additional charge where notification particulars are not provided on an approved diskette -	Note 1. Additional charge where notification particulars are not provided on an approved diskette -	Note 1. Additional charge where notification particulars are not provided on an approved diskette -	£200
Note 2. Additional charge where an adequate risk assessment is not included -	Note 2. Additional charge where an adequate risk assessment is not included -	Note 2. Additional charge where an adequate risk assessment is not included -	£2500
Note 3. Additional charge where an adequate risk assessment is not included -	Note 3. Additional charge where an adequate risk assessment is not included -	Note 3. Additional charge where an adequate risk assessment is not included -	£550
---	---	---
	GIVEN under my Official Seal, this 29 day of November 2000.	GIVEN under my Official Seal, this 29 day of November 2000.
		[image omitted]
		Mary Harney, T.D.,
		Minister for Enterprise, Trade and Employment

Explanatory Note

(This note is not part of the instrument and does not purport to be a legal interpretation).

These Regulations implement Commission Directives 98/98/EEC (the 25^th Adaptation to Technical Progress (ATP) of Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances), 2000/32/EC (the 26^th Adaptation to Technical Progress) and 2000/33/EC (the 27^th Adaptation to Technical Progress). The Regulations additionally replace 4 sets of Regulations, (a) the European Communities (Dangerous Substances) (Classification, Packaging and Labelling) Regulations, 1994 ( S.I. No. 77 of 1994 ). (b) the European Communities (Dangerous Substances) (Classification, Packaging, Labelling and Notification) (Amendment) Regulations, 1998 ( S.I. No. 317 of 1998 ), (c) The European Communities (Dangerous Substances) (Classification, Packaging, Labelling and Notification) (Amendment) (No. 2) Regulations, 1998 ( S.I. No. 513 of 1998 ) and (d) the European Communities (Dangerous Substances) (Classification, Packaging, Labelling and Notification) (Amendment) Regulations, 1999 ( S.I. No. 363 of 1999 ) with a single consolidated set of Regulations.

The consolidated Regulations thus also implement Council Directive 92/32/EEC, amending for the 7th time Directive 67/548/EEC, together with Council Directive 96/56/EC and Commission Directives 92/69/EEC (17^th ATP), 93/21/EEC (18^th ATP), 93/72/EEC (19^th ATP), 93/101/EC (20^th ATP), 94/69/EC (21^st ATP), 96/54/EC (22^nd ATP), 97/69/EC (23^rd ATP) and 98/73/EC (24^th ATP). Related Commission Directives on Risk Assessment (93/67/EEC), on substances for which equivalent European Community notification or approval systems exist (93/90/EEC), data requirements for polymers (93/105/EC) and requirements for Safety Data Sheets (91/155/EEC and 93/112/EC) are also implemented.

The aim of the Regulations is to protect man and the environment from the harmful effects of both new substances and existing dangerous substances. The Regulations apply to all substances which are intended to be placed on the market either on their own or in a preparation with exceptions for certain categories of substances such as medicinal, cosmetic, pesticide, waste, etc., products which are covered by other Directives.

They require each manufacturer, importer or other person proposing to place any new chemical on the market for the first time to submit to the competent authority a notification dossier containing details of tests to which the substance has been subjected and the proposed classification and labelling of the substance.

The Regulations also require suppliers to put warning labels on containers for dangerous substances and to ensure that the containers are properly designed, constructed and secured to prevent spillage or seepage during normal use. Safety data sheets must be supplied for dangerous substances covered by these Regulations.

Commission Directive 98/98/EEC of 15 December, 1998, adapts to technical progress Annexes I, III, IV and VI of Directive 67/548/EEC. The Directive adds a number of additional dangerous substances to Annex I the list of substances classified and labelled as dangerous in the European Community, amends the classification and labelling of a number of other dangerous substances already included in Annex I, and deletes a number of existing entries in the Annex. Additional risk phrases are included in Annex III of the Directive (provided as Schedule 3 of the Regulations), additional safety phrases in Annex IV (provided as Schedule 4 of the Regulations) and Annex VI, the classification and guide (provided as Schedule 6 of the Regulations) is amended.

Commission Directive 2000/32/EEC of 19 May, 2000, adapts to technical progress Annexes I, IV, V and IX of Directive 67/548/EEC. The Directive adds a number of additional dangerous substances to Annex I and amends the classification and labelling of a number of other dangerous substances already included in the Annex. Additional safety phrases are included in Annex IV, a number of additional testing methods are included in Annex V, the harmonised European Union methods for the testing of chemicals for hazardous properties, and Annex IX, the provisions relating to child-proof fastening is amended.

Commission Directive 2000/33/EEC of 25 April, 2000, adapts to technical progress Annex V of Directive 67/548/EEC. Additional test methods are incorporated into Annex V.

The Hazardous Substances Assessment Unit of the Health and Safety Authority, 10 Hogan Place, Dublin 2. is the competent authority to which notifications under these Regulations should be sent.

Published by the Stationery Office,

Dublin 8.

Footnotes