The information provided shall be sufficient to precisely identify each active substance and define it in terms of its specification and nature.
The name and address of the applicant shall be provided, as well as the name, position, telephone, e-mail address and telefax number of a contact point.
The name and address of the producer of the active substance shall be provided, as well as the name and address of each manufacturing plant in which the active substance is manufactured. A contact point (name, telephone, e-mail address and telefax number) shall be provided. Where following approval of the active substances, there are changes in the location or number of producers, the information required shall again be notified to the Commission, the Authority and the Member States.
The International Organization for Standardization (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, shall be provided.
The chemical name as given in Part III of Annex VI to Regulation (EC) No 1272/2008, or, if not included in that Regulation, in accordance with both the International Union of Pure and Applied Chemistry (IUPAC) and Chemical Abstracts (CA) nomenclature, shall be provided, where applicable.
Code numbers used to identify the active substance, and where available, formulations containing the active substance, during development work, shall 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, shall be stated.
Chemical Abstracts Service (CAS), European Commission (EC) and Collaborative International Pesticides Analytical Council (CIPAC) numbers, where they exist, shall be reported.
The molecular formula, molar mass and structural formula of the active substance, and where relevant, the structural formula of each isomer present in the active substance, shall be provided.
For plant extracts, a different approach may be taken if adequately justified.
The method of manufacture, in terms of the identity (name, CAS number, structural formula) and purity of the starting materials and whether they are commercially available, the chemical pathways involved, and the identity of impurities present in the final product, shall be provided, for each manufacturing plant. Detailed information shall be given as to the origin of those impurities. Each impurity shall be categorised as resulting from side reactions, impurities in the starting material, remaining reaction intermediates or starting materials. Their toxicological, ecotoxicological and environmental relevance shall be addressed. This information shall also include impurities that are not detected but that could theoretically be formed. Generally process engineering information is not required.
Where the required information is provided for a pilot plant production system, that information shall again be provided once industrial scale production methods and procedures have stabilised. Where available, industrial scale data shall be provided before approval under Regulation (EC) No 1107/2009. Where data on industrial scale production are not available, a justification shall be provided.
The minimum content in g/kg of pure active substance in the manufactured material used for production of plant protection products, shall be reported. A justification shall be provided for the minimum content proposed in the specification; this shall include a statistical analysis of the data on at least five representative batches, as referred to in point 1.11. Additional supporting data may be provided to further justify the technical specification.
Where the required information is provided for a pilot plant production system, that information shall again be provided once industrial scale production methods and procedures have stabilised. Where available, industrial scale data shall be provided before approval under Regulation (EC) No 1107/2009. Where data on industrial scale production are not available, a justification shall be provided.
If the active substance is manufactured as technical concentrate (TK), the minimum and maximum content of the pure active substance shall be given, along with its content in the theoretical dry weight material.
If the active substance is a mixture of isomers, the ratio or the ratio range of the content of isomers shall be provided. The relative biological activity of each isomer, both in terms of efficacy and toxicity, shall be reported.
For plant extracts, a different approach may be taken if adequately justified.
The minimum and maximum content in g/kg of each additive shall be provided.
The maximum content in g/kg of each further component other than additives shall also be provided.
If the active substance is manufactured as technical concentrate (TK), the maximum content of each impurity shall be given, along with their content in the theoretical dry weight material.
Isomers that are not part of the ISO common name are considered as impurities.
Where the information provided does not fully identify a component (for example condensates), detailed information on the composition shall be provided for each such component.
Where the required information is provided for a pilot plant production system, that information shall again be provided once industrial scale production methods and procedures have stabilised. Where available, industrial scale data shall be provided before approval under Regulation (EC) No 1107/2009. Where data on industrial scale production are not available, a justification shall be provided.
For plant extracts, a different approach may be taken if adequately justified.
The trade name of components added to the active substance, prior to manufacture of the plant protection product, to preserve stability and facilitate ease of handling, hereinafter ‘additives’, shall also be provided. The following information shall, where relevant, be provided for such additives:
chemical name in accordance with IUPAC and CA nomenclature;
ISO common name or proposed common name if available;
CAS number, EC number;
molecular and structural formula;
molar mass;
minimum and maximum content in g/kg; and
function (for example stabiliser).
Impurities present in quantities of 1 g/kg or more shall be considered as significant. For significant impurities the following information, where relevant, shall be provided:
chemical name in accordance with IUPAC and CA nomenclature;
ISO common name or proposed common name, if available;
CAS number, EC number;
molecular and structural formula;
molar mass; and
maximum content in g/kg.
Information on how the structural identity of the impurities was determined shall be given.
Impurities that are particularly undesirable because of their toxicological, ecotoxicological or environmental properties, shall be considered as relevant. For relevant impurities the following information, where relevant, shall be provided:
chemical name in accordance with IUPAC and CA nomenclature;
ISO common name or proposed common name if available;
CAS number, EC number;
molecular and structural formula;
molar mass; and
maximum content in g/kg.
Information on how the structural identity of the impurities was determined shall be reported.
At least five representative batches from recent and current industrial scale production of the active substance shall be analysed for content of pure active substance, impurities, additives and each further component other than additives, as appropriate. All of the representative batches shall be within the last five years of manufacture. Where data from the last five years of production are not available, a justification shall be provided. The analytical results reported shall include quantitative data, in terms of g/kg content, for all components present in quantities of 1 g/kg or more and typically should account for at least 980 g/kg of the material analysed. For plant extracts and semiochemicals (such as pheromones), justified exemptions can be made. The statistical basis for the content proposed in the technical specification shall be explained (for example: maximum level found in practice, average plus three standard deviations of levels found in practice, etc.). Supporting data may be provided to further justify the technical specification. The actual content of components which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties shall be determined and reported even if present in quantities below 1 g/kg. Data reported shall include the results of the analysis of individual samples and a summary of that data, to show the minimum, maximum and mean content of each relevant component.
Where an active substance is produced in different plants the information set out in the first paragraph shall be provided for each of the plants separately.
In addition, where relevant, samples of the active substance produced at laboratory scale or in pilot production systems, shall be analysed, if such material was used in generating toxicological or ecotoxicological data. If this data is not available a justification shall be provided.
Where the information provided relates to a pilot plant production system, the information required shall again be provided once industrial scale production methods and procedures have stabilised. Where available, industrial scale data shall be provided before approval under Regulation (EC) No 1107/2009. Where data on industrial scale production are not available, a justification shall be provided.