The information provided must be sufficient to identify with precision each active substance, to define it in terms of its specification and to characterize it as to its nature. The information and data referred to, unless otherwise specified, are required for all active substances.
The name and address of the applicant (permanent Community address) must be provided as must the name, position, telephone and telefax number of the appropriate person to contact.
Where, in addition, the applicant has an office, agent or representative in the Member State to which the application for inclusion in Annex I is submitted, and if different, in the Rapporteur Member State appointed by the Commission, the name and address of the local office, agent or representative must be provided, as must the name, position, telephone and telefax number of the appropriate person to contact.
The name and address of the manufacturer or manufacturers of the active substance must be provided as must the name and address of each manufacturing plant in which the active substance is manufactured. A contact point (preferably a central contact point, to include name, telephone and telefax number) must be provided, with a view to providing updating information and responding to queries arising, regarding manufacturing technology, processes and the quality of product (including where relevant, individual batches). Where following inclusion of the active substances in Annex I, there are changes in the location or number of manufacturers, the information required must again be notified to the Commission and the Member States.
The ISO common name, or proposed ISO common name and where relevant, other proposed or accepted common names (synonyms), including the name (title) of the nomenclature authority concerned, must be provided.
The Chemical name as given in Annex I to Directive 67/548/EEC, or, if not included in this Directive, in accordance with both IUPAC and CA nomenclature, must be provided.
Code numbers used to identify the active substance, and where available, formulations containing the active substance, during development work, must be reported. For each code number reported, the material to which it relates, the period for which it was used, and the Member States or other countries in which it was used and is being used, must be stated.
Chemical Abstracts, EEC (EINECS or ELINCS), and CIPAC numbers, where they exist, must be reported.
The molecular formula, molecular mass and structural formula of the active substance, and where relevant, the structural formula of each stereo and optical isomer present in the active substance, must be provided.
The method of manufacture, in terms of the identity of the starting materials, the chemical pathways involved, and the identity of by-products and impurities present in the final product, must be provided, for each manufacturing plant. Generally process engineering information is not required.
Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized.
The minimum content in g/kg of pure active substance (excluding inactive isomers) in the manufactured material used for production of formulated products, must be reported.
Where the information provided relates to a pilot plant production system, the information required must again be provided to the Commission and the Member States once industrial scale production methods and procedures have stabilized, if production changes result in a changed specification of purity.
The maximum content in g/kg of inactive isomers as well as the ratio of the content of isomers/diastereo-isomers, where relevant, must be provided. In addition, the maximum content in g/kg of each further component other than additives, including by-products, and impurities, must be provided. In the case of additives the content in g/kg must be provided.
For each component, present in quantities of 1 g/kg or more, the following information, where relevant, must be provided:
chemical name according to IUPAC and CA nomenclature,
ISO common name or proposed common name if available,
CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available,
molecular and structural formula,
molecular mass, and
maximum content in g/kg.
Where the manufacturing process is such that impurities and by-products which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties could be present in the active substance, the content of each such compound must be determined and reported. In such cases, the analytical methods used and the limits of determination, which must be sufficiently low, for each compound of concern, must be reported. Additionally the following information, where relevant, must be provided:
chemical name according to IUPAC and CA nomenclature,
ISO common name or proposed common name if available,
CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available,
molecular and structural formula,
molecular mass, and
maximum content in g/kg.
Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized, if production changes result in a changed specification of purity.
Where the information provided does not fully identify a component viz. condensates, detailed information on the composition must be provided for each such component.
The trade name of components added to the active substance, prior to manufacture of formulated product, to preserve stability and facilitate ease of handling, where they are used, must also be provided. Additionally the following information, where relevant, must be provided for such additives:
chemical name according to IUPAC and CA nomenclature,
ISO common name or proposed common name if available,
CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available,
molecular and structural formula,
molecular mass, and
maximum content in g/kg.
For added components, other than active substance and other than impurities resulting from the manufacturing process, the function of the component (additive) must be given:
antifoaming agent,
antifreeze,
binder,
other (specify),
buffer,
dispersing agent,
stabilizer.
Representative samples of the active substance must be analysed for content of pure active substance, inactive isomers, impurities and additives, as appropriate. The analytical results reported must include quantitative data, in terms of g/kg content, for all components present in quantities of more than 1 g/kg and typically should account for at least 98 % of the material analysed. The actual content of components which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties, must be determined and reported. Data reported must include the results of the analysis of individual samples and a summary of that data, to show the minimum or maximum and typical content of each relevant component, as appropriate.
Where an active substance is produced in different plants this information must be provided for each of the plants separately.
In addition, where available and relevant, samples of the active substance produced in laboratory scale or pilot production systems, must be analyzed, if such material was used in generating toxicological or ecotoxicological data.]
Textual Amendments
Substance within the meaning of the definition of Article 2, point 3.