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The Notification of New Substances Regulations 1993

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Regulations 4,6(1) and (2) and 7

SCHEDULE 2(This Schedule sets out the provisions of Annex VII to the Directive)INFORMATION REQUIRED IN THE TECHNICAL DOSSIERS

PART Ainformation required for the technical dossier for a full notification under regulation 4(1)

Tests under this Part shall be according to methods recognised and recommended by the competent international bodies where such recommendations exist.

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.

0.IDENTITY OF MANUFACTURER AND THE IDENTITY OF THE NOTIFIER: LOCATION OF THE PRODUCTION SITE
For substances manufactured outside the Communities and for which, for the purpose of notification, the notifier has been designated as the manufacturer’s sole representative, the identities and addresses of the importers who will be bringing the substance into the Communities.
1.IDENTITY OF THE SUBSTANCE
1.1Name
1.1.1Names in the IUPAC nomenclature
1.1.2Other names (usual name, trade name, abbreviation)
1.1.3CAS number and CAS name (if available)
1.2Molecular and structural formula
1.3Composition of the substance
1.3.1Degree of purity (%)
1.3.2Nature of impurities, including isomers and by-products
1.3.3Percentage of (significant) main impurities
1.3.4If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude: ..ppm; .. %
1.3.5Spectral data (UV, IR, NMR or mass spectrum)
1.3.6Chromatographic data (HPLC, GC)
1.4Methods 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
2.0Production
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.
2.0.1Technological process used in production
2.0.2

Exposure estimate related to production:

  • working environment,

  • environment

2.1Proposed 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.
2.1.1Types of use: description of the function and the desired effects
2.1.1.1Technological 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

2.1.1.3Form under which the substance is marketed: substance, preparation, product
2.1.1.4Concentration 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

2.1.3Where known and where appropriate, the identity of the recipients of the substance
2.1.4Waste quantities and composition of waste resulting from the proposed uses (where known)
2.2Estimated 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 Communities 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

2.3Recommended methods and precautions concerning:
2.3.1– Handling
2.3.2–Storage
2.3.3–Transport
2.3.4Fire (nature of combustion gases or pyrolysis, where proposed uses justify this)
2.3.5Other dangers, particularly chemical reaction with water
2.3.6If relevant, information concerning the susceptibility of the substance to explode when presented in the form of a dust
2.4Emergency measures in the case of accidental spillage
2.5Emergency measures in the case of injury to persons (e.g. poisoning)
2.6Packaging
3.PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE
3.0State of the substance at 20°C and 101.3 kPa
3.1Melting point
3.2Boiling point
3.3Relative density
3.4Vapour pressure
3.5Surface tension
3.6Water solubility
3.8Partition coefficient n-octanol/water
3.9Flash point
3.10Flammability
3.11Explosive properties
3.12Self ignition temperature
3.13Oxidising properties
3.15Granulometry:
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.TOXICOLOGICAL STUDIES
4.1Acute 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 inhalative route.
4.1.1Administered orally
4.1.2Administered by inhalation
4.1.3Administered cutaneously
4.1.5Skin irritation
4.1.6Eye irritation
4.1.7Skin sensitization
4.2Repeated 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.
4.2.1Repeated dose toxicity (28 days)
4.3Other effects
4.3.1Mutagenicity
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 to the Directive should be carried out.
4.3.2Screening for toxicity related to reproduction
4.3.3Assessment of the toxicokinetic behaviour of a substance to the extent that can be derived from base set data and other relevant information
5.ECOTOXICOLOGICAL STUDIES
5.1Effects on organisms
5.1.1Acute toxicity for fish
5.1.2Acute toxicity for daphnia
5.1.3Growth inhibition test on algae
5.1.6Bacteriological 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,

  • abiotic: 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.

5.3Absorption/desorption screening test
6.POSSIBILITY OF RENDERING THE SUBSTANCE HARMLESS
6.1For industry/skilled trades
6.1.1Possibility of recycling
6.1.2Possibility of neutralization of unfavourable effects
6.1.3

Possibility of destruction:

  • controlled discharge,

  • incineration,

  • water purification station,

  • others

6.2For the public at large
6.2.1Possibility of recycling
6.2.2Possibility of neutralization of unfavourable effects
6.2.3

Possibility of destruction:

  • controlled discharge,

  • incineration,

  • water purification station,

  • others.

PART Binformation required for the technical dossier for a notification under regulation 6(1)

Tests under this Part shall be according to methods recognised and recommended by the competent international bodies where such recommendations exist.

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.

0.IDENTITY OF MANUFACTURER AND THE IDENTITY OF THE NOTIFIER: LOCATION OF THE PRODUCTION SITE
For substances manufactured outside the Communities and for which, for the purpose of notification, the notifier has been designated as the manufacturer’s sole representative, the identities and addresses of the importers who will be bringing the substance into the Communities.
1.IDENTITY OF THE SUBSTANCE
1.1Name
1.1.1Names in the IUPAC nomenclature
1.1.2Other names (usual name, trade name, abbreviation)
1.1.3CAS number and CAS name (if available)
1.2Molecular and structural formula
1.3Composition of the substance
1.3.1Degree of purity (%)
1.3.2Nature of impurities, including isomers and by-products
1.3.3Percentage of (significant) main impurities
1.3.4If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude: ..ppm; .. %
1.3.5Spectral data (UV, IR, NMR or mass spectrum)
1.3.6Chromatographic data (HPLC, GC)
1.4Methods 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
2.0Production
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.
2.0.1Technological process(es) used in production
2.0.2

Exposure estimate related to production:

  • working environment,

  • environment

2.1Proposed 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.
2.1.1Types of use: description of the function and the desired effects
2.1.1.1Technological 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

2.1.1.3Form under which the substance is marketed: substance, preparation, product
2.1.1.4Concentration 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

2.1.3Where known and where appropriate, the identity of the recipients of the substance
2.2Estimated 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 Communities 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

2.3Recommended 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)
2.3.5Other dangers, particularly chemical reaction with water
2.4Emergency measures in the case of accidental spillage
2.5Emergency measures in the case of injury to persons (e.g. poisoning)
2.6Packaging
3.PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE
3.0State of the substance at 20 degrees C and 101.3 kPa
3.1Melting point
3.2Boiling point
3.6Water solubility
3.8Partition coefficient n-octanol/water
3.9Flash point
3.10Flammability
4.TOXICOLOGICAL STUDIES
4.1Acute toxicity
For tests 4.1.1 to 4.1.2 one route of administration is sufficient.Substances other than gases should be treated by oral administration.Gases should be tested by inhalation.
4.1.1Administered orally
4.1.2Administered by inhalation
4.1.5Skin irritation
4.1.6Eye irritation
4.1.7Skin sensitization
4.3Other effects
4.3.1Mutagenicity The substance should be examined in a bacteriological (reverse mutation) test with and without metabolic activation.
5.ECOTOXICOLOGICAL STUDIES
5.2Degradation: biotic.

PART C information required for the technical dossier for a notification under regulation 6(2)

Tests under this Part shall be according to methods recognised and recommended by the competent international bodies where such recommendations exist.

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 Communities and for which, for the purpose of notification, the notifier has been designated as the manufacturer’s sole representative, the identities and addresses of the importers who will be bringing the substance into the Communities.
1.IDENTITY OF THE SUBSTANCE
1.1Name
1.1.1Names in the IUPAC nomenclature
1.1.2Other names (usual name, trade name, abbreviation)
1.1.3CAS number and CAS name (if available)
1.2Molecular and structural formula
1.3Composition of the substance
1.3.1Degree of purity (%)
1.3.2Nature of impurities, including isomers and by-products
1.3.3Percentage of (significant) main impurities
1.3.4If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude: ..ppm; .. %
1.3.5Spectral data (UV, IR, NMR or mass spectrum)
1.3.6Chromatographic data (HPLC, GC)
1.4Methods 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
2.0Production
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.
2.0.1Technological process(es) used in production
2.0.2

Exposure estimate related to production:

  • working environment,

  • environment

2.1Proposed 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.
2.1.1Types of use: description of the function and the desired effects
2.1.1.1Technological 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

2.1.1.3Form under which the substance is marketed: substance, preparation, product
2.1.1.4Concentration 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

2.1.3Where known and where appropriate, the identity of the recipients of the substance
2.2Estimated 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 Communities 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

2.3Recommended methods and precautions concerning:
2.3.1– Handling
2.3.2– Storage
2.3.3– Transport
2.3.4Fire (nature of combustion gases or pyrolysis, where proposed uses justify this)
2.3.5Other dangers, particularly chemical reaction with water
2.4Emergency measures in the case of accidental spillage
2.5Emergency measures in the case of injury to persons (e.g. poisoning)
2.6Packaging
3.PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE
3.0State of the substance at 20 degrees C and 101.3 kPa
3.9Flash point
3.10Flammability
4.TOXICOLOGICAL STUDIES
4.1Acute toxicity
One route of administration is sufficient.Substances other than gases should be tested by oral administration. Gases should be tested by inhalation.
4.1.1Administered orally
4.1.2Administered by inhalation.

PART D(The provisions set out in this Part were introduced into Annex VII of the Directive by Commission Directive 1993/105/EEC)information required for the technical dossier for a notification under regulation 7

Without prejudice to the provisions of Article 3(1) of the Directive tests under this Part shall be according to methods recognized and recommended by the competent international bodies where such recommendations exist.

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.

A.

For the purpose of this Part

  • ‘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 section C.2 of this Part.

  • ‘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.

  • ‘MW’ is the molecular weight (of any particular molecule).

B.Family approach
To avoid unnecessary testing, grouping of polymers into families shall be allowed.

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 > 1000, 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 regulation 7
Appropriate available information on the properties of the monomer(s) may be taken into account for the assessment of the properties of the polymer.
C.1POLYMERS WITH STANDARD TEST PACKAGE
C.1.1POLYMERS PLACED ON THE COMMUNITY MARKET IN QUANTITIES OF ≥ 1 TONNE PER ANNUM (OR TOTAL QUANTITIES OF ≥ 5 TONNES)

In addition to the information and tests referred to in regulation 4(1), laid down in Part A, the following polymer-specific information is required:

1.IDENTITY OF THE SUBSTANCE
1.2.1Number-average molecular weight
1.2.2Molecular weight distribution (MWD)
1.2.3Identity and concentration of starting monomers and starting substances which will be bound in the polymer
1.2.4Indication of end groups and identity and frequency of reactive functional groups
1.3.2.1Identity of non-reacted monomers
1.3.3.1Percentage of non-reacted monomers
2.INFORMATION ON THE SUBSTANCE
2.1.1.5Statement, with relevant information, if the polymer has been developed to be environmentally degradable
3.PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE
3.6.1Water extractivity

Without prejudice to regulation 16, further tests may be required additionally in certain cases, eg:

  • 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.1.2POLYMERS PLACED ON THE COMMUNITY MARKET IN QUANTITIES OF < 1 TONNE PER ANNUM (OR TOTAL QUANTITIES OF < 5 TONNES) BUT ≥ 100 KGS PER ANNUM (OR TOTAL QUANTITIES OF ≥ 500 KGS)

In addition to the information and tests referred to in regulation 6(1), laid down in Part B, the following polymer-specific information is required:

1.IDENTITY OF THE SUBSTANCE
1.2.1Number-average molecular weight
1.2.2Molecular weight distribution (MWD)
1.2.3Identity and concentration of starting monomers and starting substances which will be bound in the polymer
1.2.4Indication of end groups and identity and frequency of reactive functional groups
1.3.2.1Identity of non-reacted monomers
1.3.3.1Percentage of non-reacted monomers
2.INFORMATION ON THE SUBSTANCE
2.1.1.5Statement, with relevant information, if the polymer has been developed to be environmentally degradable
3.PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE
3.6.1Water extractivity
C.1.3POLYMERS PLACED ON THE COMMUNITY MARKET IN QUANTITIES OF < 100 KGS PER ANNUM (OR TOTAL QUANTITIES OF < 500 KGS)

In addition to the information and tests referred to in regulation 6(2), laid down in Part C, the following polymer-specific information is required:

1.IDENTITY OF THE SUBSTANCE
1.2.1Number-average molecular weight
1.2.2Molecular weight distribution (MWD)
1.2.3Identity and concentration of starting monomers and starting substances which will be bound in the polymer
1.2.4Indication of end groups and identity and frequency of reactive functional groups
1.3.2.1Identity of non-reacted monomers
1.3.3.1Percentage of non-reacted monomers
2.INFORMATION ON THE SUBSTANCE
2.1.1.5Statement, with relevant information, if the polymer has been developed to be environmentally degradable
C.2POLYMERS FOR WHICH A REDUCED TEST PACKAGE (RTP POLYMERS) IS ACCEPTABLE

Under certain conditions the base-set test package for polymers can be reduced.

CRITERIA FOR POLYMERS FOR WHICH A REDUCED TEST PACKAGE IS ACCEPTABLE

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

(a)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:

(I)High number-average molecular weight (Mn).The competent authority shall decide whether or not a polymer satisfies this criterion;

(II)Extractivity in water (3.6.1) < 10 mg/l excluding any contribution from additives and impurities;

(III)Less than 1% with MW < 1000; the percentage refers only to molecules (components) directly derived from and including monomer(s), excluding other components e.g. additives or impurities.

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

(b)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 above are fulfilled.

If it is not possible to prove the criteria with the assigned tests, the notifier has to demonstrate compliance witha the criteria by other means. Under certain circumstances toxicological and ecotoxicological tests may be required.

C.2.1RTP POLYMERS PLACED ON THE COMMUNITY MARKET IN QUANTITIES OF ≥ 1 TONNE PER ANNUM (OR TOTAL QUANTITIES OF ≥ 5 TONNES): FULL LIST OF INFORMATION AND TESTS REQUIRED
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 identities and the addresses of the importers who will be bringing the substance into the Community.
1.IDENTITY OF THE SUBSTANCE
1.1Name
1.1.1Names in the IUPAC nomenclature
1.1.2Other names (usual name, trade name, abbreviation)
1.1.3CAS number and CAS name (if available)
1.2Molecular and structural formula
1.2.1Number-average molecular weight
1.2.2Molecular weight distribution (MWD)
1.2.3Identity and concentration of starting monomers and starting substances which will be bound in the polymer
1.2.4Indication of end groups and identity and frequency of reactive functional groups
1.3Composition of the substance
1.3.1Degree of purity (%)
1.3.2Nature of impurities, including by-products
1.3.2.1Identity of non-reacted monomers
1.3.3Percentage of (significant) main impurities
1.3.3.1Percentage of non-reacted monomers
1.3.4If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude: ..ppm, .. %
1.3.5Spectral data (UV, IR, NMR or mass spectrum)
1.3.6.1GPC
1.4Methods 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
2.0Production
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.
2.0.1Technological process used in production
2.0.2

Exposure estimates related to production:

  • working environment

  • environment

2.1Proposed 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.
2.1.1Types of use: description of the function and the desired effects
2.1.1.1Technological 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

2.1.1.3Form under which the substance is marketed: substance, preparation, product
2.1.1.4Concentration 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

2.1.3Where known and where appropriate, the identity of the recipients of the substance
2.1.4Waste quantities and composition of waste resulting from the proposed uses (where known)
2.2Estimated 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

2.3Recommended methods and precautions concerning:
2.3.1– Handling
2.3.2– Storage
2.3.3– Transport
2.3.4Fire (nature of combustion gases or pyrolysis, where proposed uses justify this)
2.3.5Other dangers, particularly chemical reaction with water
2.3.6If relevant, information concerning the susceptibility of the substance to explode when presented in the form of a dust
2.4Emergency measures in the case of accidental spillage
2.5Emergency measures in the case of injury to persons (e.g. poisoning)
2.6Packaging
3.PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE
3.0State of the substance at 20°C and 101.3 kPa
3.1Melting range (e.g. from the thermal stability test)
3.3Relative density
3.6.1Water extractivity
3.10Flammability
3.11Explosive properties
3.12Auto-flammability
3.15Particle size
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 distribution of the substance as it will be marketed.
3.16Thermal 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 acceptance of the notification the competent authority may on the basis of the presence of reactive groups or structural/physical characteristics or knowledge about 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, 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 acceptance of the notification, the competent authority may on the basis of the presence of reactive groups, structural/physical characteristics or knowledge of 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
6.1For industry/skilled trades
6.1.1Possibility of recycling
6.1.2Possibility of neutralization of unfavourable effects
6.1.3

Possibility of destruction:

  • controlled discharge

  • incineration

  • water purification station

  • others

6.2For the public at large
6.2.1Possibility of recycling
6.2.2Possibility of neutralization of unfavourable effects
6.2.3

Possibility of destruction:

  • controlled discharge

  • incineration

  • water purification station

  • others

C.2.2RTP POLYMERS PLACED ON THE COMMUNITY MARKET IN QUANTITIES OF < 1 TONNE PER ANNUM (OR TOTAL QUANTITIES OF < 5 TONNES): FULL LIST OF INFORMATION AND TESTS REQUIRED
0.IDENTITY OF MANUFACTURER AND THE IDENTITY OF THE NOTIFIER: LOCATION OF THE PRODUCTION SITE:
For substances manufactured outside the Communities and for which, for the purpose of notification, the notifier has been designated as the manufacturer’s sole representative, the identities and the addresses of the importers who will be bringing the substance into the Communities.
1.IDENTITY OF THE SUBSTANCE
1.1Name
1.1.1Names in the IUPAC nomenclature
1.1.2Other names (usual name, trade name, abbreviation)
1.1.3CAS number and CAS name (if available)
1.2Molecular and structural formula
1.2.1Number-average molecular weight
1.2.2Molecular weight distribution (MWD)
1.2.3Identity and concentration of starting monomers and starting substances which will be bound in the polymer
1.2.4Indication of end groups and identity and frequency of reactive functional groups
1.3Composition of the substance
1.3.1Degree of purity (%)
1.3.2Nature of impurities, including by-products
1.3.2.1Identity of non-reacted monomers
1.3.3Percentage of (significant) main impurities
1.3.3.1Percentage of non-reacted monomers
1.3.4If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude: .. ppm, .. %
1.3.5Spectral data (UV, IR, NMR or mass spectrum)
1.3.6.1GPC
1.4Methods 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
2.0Production
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.
2.0.1Technological process used in production
2.0.2

Exposure estimates related to production:

  • working environment

  • environment

2.1Proposed 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

2.1.1.1Technological 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

2.1.1.3Form under which the substance is marketed: substance, preparation, product
2.1.1.4Concentration 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

2.1.3Where known and where appropriate, the identity of the recipients of the substance
2.1.4Waste quantities and composition of waste resulting from the proposed uses (where known)
2.2Estimated 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 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

2.3Recommended methods and precautions concerning:
2.3.1– Handling
2.3.2– Storage
2.3.3– Transport
2.3.4Fire (nature of combustion gases or pyrolysis, where proposed uses justify this)
2.3.5Other dangers, particularly chemical reaction with water
2.3.6If relevant, information concerning the susceptibility of the substance to explode when present in the form of a dust
2.4Emergency measures in the case of accidental spillage
2.5Emergency measures in the case of injury to persons (e.g. poisoning)
2.6Packaging
3.PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE
3.0State of the substance at 20 degrees C and 101.3 kPa
3.1Melting range (e.g. from the thermal stability test)
3.6.1Water extractivity
3.10Flammability

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