This information replaces the information published in the Bundesanzeiger on 1 June 2011 (issue 84, p. 2022) previously shown here.

New information or the first-time adoption of a classification and labelling according to Regulation (EC) No. 1272/2008 (CLP Regulation) may lead to changes in the classification of active substances, safeners, synergists and other ingredients of plant protection products under CLP Regulation (this also applies to the additional EU hazard statements for labelling mentioned in the text).

Such changes to harmonised classification/labelling are based on a procedure under the responsibility of the European Chemicals Agency (ECHA). As a result of the evaluation process, the ECHA publishes opinions of the Committee for Risk Assessment (RAC-Opinion) on the substance hazards of the evaluated substances. RAC-Opinions form the technical basis for a delegated EU regulation amending Annex VI of the CLP Regulation (ATP). This contains the harmonised classification and labelling of all regulated substances. The results of the RAC-Opinions are generally implemented without changes and are therefore a valuable source of information for obtaining early indications of amendments to the CLP Regulation. The documents are available on the ECHA´s website.

Regulation (EC) No 1107/2009 (Art. 56 para. 1 and Art. 31 para. 2) requires authorisation holders to inform the BVL immediately of any potentially harmful effects. This also includes changes to the classification and labelling of active substances, safeners, synergists and other ingredients in accordance with the CLP Regulation. Depending on the nature of the changes or potentially harmful effects, updated safety data sheets and, if necessary, new documents or studies must be submitted. Updated safety data sheets must be submitted to the BVL as soon as possible after publication of the RAC-Opinion, but no later than the entry into force of the ATP. Other documents, such as studies on the relevance of groundwater metabolites, must be submitted or announced to the BVL as soon as possible after the changes of classification become known, e.g. on the basis of the RAC-Opinion. If the evaluation of such documents is to be carried out by other EU Member States, BVL must be informed of the envisaged procedure.

Three areas of regulation for authorised plant protection products that may be affected by the changes to classification and labelling are listed below. They must be taken into account by the authorisation holders of plant protection products in their notifications. In addition to new labelling provisions based on the CLP Regulation, it may be necessary to review the impact of the changed classification and labelling on the authorisation of the plant protection products concerned and to make changes where necessary.

(1) Updating the classification and labelling of the product
Depending on the current concentration limits, it may be necessary for authorisation holders to update the classification and labelling of plant protection products. In Germany, the entity responsible for the placing on the market of the plant protection product is generally regarded responsible for the correct classification and labelling of a plant protection product. This is in accordance with the legislation on the classification and labelling of hazardous substances under Regulation (EC) No. 1272/2008.

In addition, Regulation (EC) No. 1107/2009 must be complied with. In accordance with the second subparagraph of Article 31(2), in case of a change in the classification and labelling of active substances and co-formulants that has an impact on the classification and labelling of the plant protection product in accordance with Regulation (EC) No 1272/2008, the label of the plant protection product shall be adjusted. In order to be allowed to continue to place affected plant protection products on the market, they must be reclassified and relabelled on the labels and in the accompanying documents at the latest by the date of entry into force of the ATP.
 

In the risk assessment of plant protection products, risk mitigation measures for safe use are allocated, among other things, on the basis of the classification and labelling of the product (details can be found in the publication "Hazard and risk based allocation of safety instructions to operators handling pesticides" by Lichtenberg et al., 2015). A change in the classification and labelling of a plant protection product can therefore lead to changes in the labelling requirements and safety instructions. BVL examines the information and proposals of the applicant regarding the new classification and labelling of the plant protection product on the basis of an updated safety data sheet and, if necessary, other documents.
If required, BVL initiates the procedure for necessary adjustments to the labelling requirements and safety instructions. In order to ensure a safe use, these adaptations should be implemented as quickly as possible, but at the latest by the time the ATP enters into force. The BVL reserves the right to request adjustments to the labelling requirements and instructions for use by means of an amended authorisation certificate in the event of serious new findings before the ATP comes into force.

(2) Authorisation of the product/applications in home and allotment gardens
Plant protection products may only be used in the home and allotment garden if they are not classified as carcinogenic, mutagenic, toxic for reproduction, endocrine disrupting, sensitising, very toxic, toxic, explosive or corrosive.
This corresponds to the following classifications:

*In individual cases, a plant protection product that is classified as sensitising may be approved for use in home and allotment gardens if, for example, exposure to the undiluted product is negligible due to appropriate packaging and/or dosing systems when used as intended or if the ready-to-use spray mixture is diluted to such an extent that it is no longer to be regarded as sensitising.

If changes according to an updated classification based on CLP Regulation results in a new classification of the plant protection product with the above-mentioned properties, authorisations for use in home and allotment gardens will be withdrawn after consultation with the authorisation holders. If suitable, the plant protection product may alternatively be reformulated.

(3) Updating the assessment of the toxicological relevance of groundwater metabolites
Metabolites of active substances that contaminate the groundwater at concentrations > 0.1 µg/L on the basis of model calculations or measurement results must not have any genotoxic potential. For certain classifications of active substances, it must also be demonstrated that such metabolites do not share the toxicological properties of the parent substance. The relevant hazard classes and categories are defined in the European guidance document on the relevance assessment of metabolites in groundwater (Sanco/221/2000 - rev.11).

A new or updated classification of a pesticide active substance may require a new assessment of the relevance of metabolites. The guidance document states as a basic principle that metabolites whose parent substance has one of the classifications listed below are to be considered toxicologically relevant until their ‘non-relevance’ has been demonstrated by studies.
The following classifications are to be into considered:

If a new relevance assessment of metabolites is to be carried out, it will be necessary to submit new information or studies on groundwater metabolites. If new studies are planned, these should be initiated as soon as possible after the new classification becomes known (e.g. publication of the respective RAC option). This is necessary to ensure a timely assessment and to limit or avoid suspension orders for authorisations. If relevant metabolites contaminate groundwater at concentrations above 0.1 µg/L, additional risk mitigation measures are required to reduce groundwater contamination or the use concerned will lose its authorisation and will have to be withdrawn.

According to Article 56 of Regulation (EC) No. 1107/2009, authorisation holders are obliged to review the effects or new findings resulting from a change in the classification of active substances or co-formulants on the authorisation of their plant protection products. They must notify the BVL of the results.

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