S.I. No. 116/2003 - European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations 2003

0.	IDENTITY OF MANUFACTURER AND THE IDENTITY OF THE NOTIFIER: LOCATION OF THE PRODUCTION SITE 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.	IDENTITY OF THE SUBSTANCE
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.	INFORMATION ON THE SUBSTANCE
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.	PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE
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.	TOXICOLOGICAL STUDIES
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.	MutagenicityThe substance should be examined in a bacteriological (reverse mutation) test with and without metabolic activation.
5.	ECOTOXICOLOGICAL STUDIES
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.

0.	IDENTITY OF MANUFACTURER AND THE NOTIFIER IF THESE ARE NOT THE SAME; LOCATION OF THE PRODUCTION SITE 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.	IDENTITY OF THE SUBSTANCE
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.	INFORMATION ON THE SUBSTANCE
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:	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 calender 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.	PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE
3.0.	State of the substance at 20 oC and 101,3 kPa
3.9.	Flash-point
3.10.	Flammability
4.	TOXICOLOGICAL STUDIES
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.I	DENTITY OF THE SUBSTANCE
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.	INFORMATION ON THE SUBSTANCE
2.1.1.5.	Statement, with relevant information, if the polymer has been developed to be environmentally degradable
3.	PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE
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.	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	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 tests referred to in Article 8 (1), laid down in Annex VII B, the following polymer-specific information is required:	In addition to the information and tests referred to in Article 8 (1), laid down in Annex VII B, the following polymer-specific information is required:
1. IDENTITY OF THE SUBSTANCE	1. IDENTITY OF THE SUBSTANCE
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 monomer
1.3.3.1.	Percentage of non-reacted monomers
2. INFORMATION ON THE SUBSTANCE	2. INFORMATION ON THE SUBSTANCE
2.1.1.5. Statement, with relevant information, if the polymer has been developed to be environmentally degradable	2.1.1.5. Statement, with relevant information, if the polymer has been developed to be environmentally degradable
3. PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE	3. PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE
4.1.8	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:	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. IDENTITY OF THE SUBSTANCE	1. IDENTITY OF THE SUBSTANCE
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. INFORMATION ON THE SUBSTANCE	2. INFORMATION ON THE SUBSTANCE
2.1.1.5. Statement, with relevant information, if the polymer has been developed to be environmentally degradable	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 & ge; 1 t/a or total quantities of & ge; 5 t, the following criteria define those polymers for which a reduced test package is acceptable:	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 & ge; 1 t/a or total quantities of & ge; 5 t, the following criteria define those polymers for which a reduced test package is acceptable:
I.	High number-average molecular weight (Mn) (1);
II.	Extractivity in water (3.6.1) < 10 mg/l 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.	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 criteria by other means. Under certain circumstances toxicological and ecotoxicological tests may be required.	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 criteria 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	C.2.1. Polymers placed on the Community market in quantities of >=1 t/a or total quantities of >=5 t
0. Identity of manufacturer and the identity of the notifier: Location of the production site. 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.	0. Identity of manufacturer and the identity of the notifier: Location of the production site. 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. IDENTITY OF THE SUBSTANCE	1. IDENTITY OF THE SUBSTANCE
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 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.	GPC1.
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.	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.	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 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 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. PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE	3. PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE
3.0.	State of the substance at 20° C and 101,3 kPa
3.1	Melting range (e. g. from the termal 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.	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
4. TOXICOLOGICAL STUDIES 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.	4. TOXICOLOGICAL STUDIES 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.
5. ECOTOXICOLOGICAL STUDIES 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 charateristics 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 extractivity (leachate test). Depending on the results of this test, any appropriate test on the leachate may be requested on a case by case basis	5. ECOTOXICOLOGICAL STUDIES 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 charateristics 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 extractivity (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. POSSIBILITY OF RENDERING THE SUBSTANCE HARMLESS

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 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 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. 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 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. PHYSICO-CHEMCIAL PROPERTIES OF THE SUBSTANCE

3.0 State of the substance at 20 °C and 101,3 kPa

3.1. Melting range (e. g. 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

Where, in accordance with the provisions of Annex VII. A related to intermediates, the relevant competent authority has authorised the application of a reduced test package to a chemical substance the requirements of this section shall be reduced as follows.

When the quantity of the substance placed on the market reaches 10 tonnes per year per manufacturer or when the total quantity of the substance placed on the market reaches 50 tonnes per manufacturer; in this case the relevant competent authority shall require all those test and studies laid down in points 3 to 6 of Annex VII. A (excepting those already performed); in addition, the relevant competent authority may require those Level 1 tests and studies related to aquatic organisms.

When the quantity of the substance placed on the market reaches 100 tonnes per year per manufacturer or when the total quantity of the substance placed on the market reaches 500 tonnes per manufacturer; in this case the relevant competent authority shall require the Level 1 tests or studies related to reproductive toxicity. The relevant competent authority may decide that the classification of the substance as an intermediate qualifying for a reduced test package constitutes a good reason why one or more tests and studies, except those related to reproductive toxicity, are not appropriate.

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

When the quantity of the substance placed on the market reaches 1,000 tonnes per year per manufacturer or when the total quantity of the substance placed on the market reaches 5,000 tonnes per manufacturer; additional studies mentioned in Level 1 or 2 would normally not be required. The relevant competent authority should however, consider additional tests and may require additional tests including the tests laid down in Levels 1 and 2 of this Annex.

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 7 ANNEX IX

PART A Provisions relating to child-proof fastenings

In addition to the provisions in Article 22(1)(e) of Directive 67/548/EEC⁷⁸ 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.

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).

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).

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 8

Regulation 24

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 9 FEES PAYABLE BY NOTIFIER

Regulation 27

Column 1	Column 2
Subject matter	Fee payable EUR
1. For a notification under Regulation 10 (1) (“base set”) (See notes 1 and 2)	€8,380
2. For a re-notification submitted in accordance with Regulation 17 (1) (See notes 1 and 2)	€1,675
3. For a notification of a substance notified at least 10 years previously (Regulation 12) (See notes 1 and 2)	€1,675
4. For additional tests submitted under Regulation 10(3)(a) (>10 tonnes per year)	€8,380
5. For additional tests submitted under Regulation 10(3)(b) (>100 tonnes per year)	€8,380
6. For additional tests submitted under Regulation 10(3)(c) (>1000 tonnes per year)	€16,760
7. For a notification under Regulation 11 (see note 3) (a) quantity of the new substance equal to or more than 100kg (Regulation 11(1))	€1,675
(b) quantity of the new substance up to 100kg79 (Regulation 11(3))	€838
8. For a successful application made by a notifier for an exemption relating to him under Regulation 15(3)	€838
Note 1. Additional charge where notification particulars are not provided on an approved diskette -	€304
Note 2. Additional charge where an adequate risk assessment is not included -	€3,809
Note 3. Additional charge where an adequate risk assessment is not included -	€838
---	---
	GIVEN under my Official Seal,
	27 March 2003,
	[image omitted]
	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 transpose for the first time Commission Directive 2001/58/EC amending for the second time Directive 91/155/EEC, relating to dangerous substances in implementation of Article 27 of Council Directive 67/548/EEC (safety data sheets) and Commission Directive 2001/59/EC, the 28^th Adaptation to Technical Progress of Council Directive 67/548/EEC. (The provisions of Commission Directive 2001/58/EC relating to dangerous preparations in implementation of European Parliament and Council Directive 1999/45/EC will be transposed in separate Regulations.)

These Regulations also retranspose 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), 98/73/EC (24^th ATP), 98/98/EEC (25^th ATP), 2000/32/EC (26^th ATP) and 2000/33/EC (27^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, 93/112/EC) are also retransposed.

These Regulations revoke the European Communities (Dangerous Substances) (Classification, Packaging and Labelling) Regulations, 2000 ( S.I. No. 393 of 2000 ).

The aim of these 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 2001/59/EC adapts to technical progress for the 28^th time Annexes I, III, V, VI VII and VIII 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 1, and deletes a number of existing entries in the Annex.

• • In addition, the Foreword to Annex I is updated. It is provided for the first time as Schedule 1 to the Regulations.

• • Additional risk phrases are included in Annex III of the Directive and are set out in Schedule 3 to the Regulations.

• • Safety advice is set out in Annex VI and is set out in Schedule 5 to the Regulations.

• • Additional test methods are incorporated into Annex V.

• • Annex VI, the general classification and labelling guide, is set out in Schedule 5 to the Regulations.

• • Annex VII is amended to contain details of the reduced test package (RTP) which can be submitted for intermediates with limited exposure and is set out in Schedule 6 to the Regulations.

• • Annex VIII is amended to detail additional tests that may be required for intermediates with limited exposure marketed in higher volumes. The Irish Competent Authority shall produce guidelines on this Reduced Test Package.

• • Annex IX contains provisions relating to child-proof fastenings and tactile warning devices and is set out in Schedule 7 to the Regulations.

• • Schedule 8 to the Regulations sets out the obligatory headings for safety data sheets.

The Fees payable by the notifier are set out in Schedule 9 to the Regulations.

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.

Footnotes