Feedback from German Social Insurance dated 3 February 2025
European Commission proposal to amend the Implementing Regulation as regards harmonised labelling requirements for plant protection products
Preliminary remarks
Commission Regulation (EU) No. 547/2011 implementing Regulation (EC) No. 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products regulates, among other things, the standard phrases to be used for the labelling of plant protection products. On the one hand, they protect human and animal health from particular risks. Since the adoption of the Commission Regulation in June 2011, Member States have regularly extended the list of standard phrases of labelling requirements for plant products at national level. With the proposed amendment submitted on 6 January 2025, the European Commission would therefore like to ensure the most uniform communication to users of plant protection products. On the other, the amendment ensures the implementation of safety precautions and risk prevention and minimisation measures.
The German Social Insurance (DSV) generally welcomes the European Commission's initiative to further harmonise the labelling requirements for plant protection products and to improve communication in the area of risk prevention and minimisation to the end users of these products. In addition to harmonising the labelling requirements, the DSV believes that the revision should aim to ensure a comprehensive level of protection for users of plant protection products.
Opinion
Standard phrases to protect operators and workers
In practice, protective clothing and gloves must be used during handling and safe disposal of plant protection products in order to ensure the safety and health of users. The DSV therefore requires Annex V, Section 2 to include information that ensures the use of the required personal protective equipment (PPE), depending on the activity being carried out. It is also important that the recommended PPE and the recommended protection level are used as a guide. In Germany, for example, gloves that comply with the ISO 18889 standard and protective clothing that complies with the EN 27065 standard are recommended for users of plant protection products. Depending on the activity, eye protection and, if necessary, respiratory protection should also be indicated.
The list of standard phrases in Annex V, Section 2 should therefore be supplemented by the following sentences:
- SPo 7: Use (personal protection equipment to be specified) when handling concentrated product.
- SPo 8: Use (personal protection equipment to be specified) during repair and cleaning work of contaminated equipment.
- SPo 9: Use (personal protection equipment to be specified) for re-entry work.
For their own safety, users should always wear long work clothes and sturdy shoes when working with plant protection products. The DSV also recommends wearing certified workwear for all activities involving plant protection products, irrespective of the other PPE to be used (such as respiratory protection) and in accordance with the specifications of the Federal Office of Consumer Protection and Food Safety (BVL). Compared to non-certified workwear, whose protective effect can vary greatly depending on the production method (material, fabric thickness, weaving technique, etc.), certified workwear (e.g. workwear of protection level C1 or C2 according to EN ISO 27065) offers a protective effect clearly defined by the manufacturer, with equally clear limits to this protective effect. Wearing such workwear provides basic protection even if other PPE is not worn. For example, when getting on and off the machine, there is a risk of contamination from residues of plant protection products adhering to the machine. Certified workwear would protect the user accordingly during their work.
Wearing suitable and therefore certified workwear is also a basic assumption for the exposure assessment as part of the authorisation procedure for a plant protection product. When assessing compliance with toxicological limit values, the exposure-reducing effect of the clothing mentioned is also taken into account. The term "certified workwear" is also used by other public bodies, e.g. the European Food Safety Authority (EFSA) or the BVL, where it refers to workwear with protection level C1 or C2 in accordance with EN ISO 27065. It also acts as a linguistic differentiation from any additional PPE to be worn.
Therefore, a standard phrase, which refers to the use of certified workwear, should be included in Annex V, Section II as the workwear should have a certain protective effect against plant protection products and is therefore PPE in legal terms. As such workwear, it must comply with Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repeal of the Directive 89/686/EEC.
- SPo 10: Use certified workwear for all activities with the plant protection product.
In terms of preventive health protection, the standard phrase SPo 6 in Annex V, Section 2 stipulates that a concentration should be specified that determines when a treated area can be re-entered. For safe implementation, users must be able to assess this.
Standard phrases for seed treatment uses
With regard to treated seeds, recital 12 of the proposed amendment points out that users should receive information on the treatment product. However, this obligation was not noted in Annex V, Section 7.2. This point should be included to protect users. In addition, users who come into contact with treated seed, for example when filling or cleaning sowing machines, should be advised to use appropriate PPE. The use of gloves (e.g. ISO 18889) and, depending on the activity or expected dust formation, the additional use of protective clothing (e.g. EN 27065) or respiratory protection are recommended for this. The list of standard phrases in Annex V, Section 7.2 should indicate the following in this respect:
- Sss 14: Use (personal protection equipment to be specified) while handling treated seeds.
Furthermore, with regard to treated seeds, the additional information on which treatment agent was used should be included in Annex 1 for user-friendly provision of information.
Instructions for using plant protection products
Both the harmonisation of the labelling of plant protection products and the harmonisation of the accompanying instructions for use are relevant for the safety and health of workers. At present, the structure and content of the instructions for use are based on national laws. The scope and quality of the information provided therefore varies greatly from one Member State to another. It is advisable to adopt the same approach as that taken in Regulation (EC) No. 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Regulation) with regard to safety data sheets. By specifying a structure in this proposed amendment, it would be possible to ensure provision of the same information to all users of a plant protection product in the EU. One possible structure could be:
- Product name, manufacturer details, contact details
- Application areas of the product and application quantities
- Hazards for humans
- Protective measures and protective equipment classified by foreseeable/ usual activities
- Environmental hazards
- Environmental protection measures
- Water protection
- Miscellaneous
Harmonisation of the instructions for use for plant protection products also makes it easier for manufacturers and importers, as only one regulation needs to be taken into account when preparing the instructions for use.
About us
The German Federal Pension Insurance (DRV Bund), the German Social Accident Insurance (DGUV), the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), the national associations of statutory health and longterm care insurance funds as well as the Social Insurance for Agriculture, Forestry and Horticulture (SVLFG) have joined forces to form the "German Social Insurance – Working Group Europe" (Deutsche Sozialversicherung Arbeitsgemeinschaft Europa e.V.) with a view to their common European policy interests. The association represents the interests of its members vis-à-vis the bodies of the European Union and other European institutions and advises the relevant players in the context of current legislative projects and initiatives. As part of a statutory insurance system, health and long-term care insurance with 75 million insured people, pension insurance with 57 million insured people and accident insurance with more than 70 million insured people in 5.2 million member companies, citizens in Germany are provided with effective protection against the consequences of major life risks.
DSV Feedback on labelling requirements for plant protection products