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News from Brussels – Stricter rules on pesticides and human substances for medical treatments & therapies

In the past few weeks the EU Commission made several legislative proposals in the areas of chemistry/food safety and safety of (medical) products. Two of those topics we would like to present in this article.

For both proposed Regulations, comments by stakeholders to the EU Commission are currently still possible.

Regulation to tighten the rules on the use of pesticides

Once again, the Commission attends to the disputed matter of pesticides. In the area of food safety/chemicals substances, it has introduced a proposal for a new regulation to reduce the use of pesticides in the EU, as part of the so-called “Farm to Fork” strategy. The proposed Regulation includes binding targets to reduce the use and risks of chemical pesticides and the use of hazardous pesticides by 50% by 2030, as well as strict new rules to enforce environmentally sustainable pest control. It also includes a ban on the use of all pesticides in certain sensitive areas.

In the recent consultation of EU member state ministers, the Commission’s proposal was welcomed in terms of sustainable use of pesticides, but at the same time concerns were expressed about the reduction target for chemical pesticides.

As with any harmonization of legislation at EU level, the particularities of member states and in this particular case, food security and competitiveness of agriculture in the EU must be taken into account.

The opportunity to submit comments on the EU Commission’s proposed regulation for stakeholders is open until September 19.

Further information at: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12413-Pesticides-sustainable-use-updated-EU-rules-_en

Stricter rules for greater safety and better quality of blood, tissues and cells

Furthermore, the Commission has presented a proposal for a Regulation in the area of the use of human tissue. This concerns medical treatments and therapies relating to all substances covered by the regulation, including blood, tissues and cells, but also breast milk or microbiota.

All substances of human origin except solid organs are supposed to be regulated, according to the proposal. In particular, risk-based measures will be introduced to strengthen national supervision, as well as measures to support national authorities by the EU.

Similar to the framework of the Medical Devices Regulation or the In Vitro Diagnostics Regulation, all bodies whose activities are relevant to the safety and quality of such substances will be subject to registration. Through a common procedure for the evaluation and authorisation of the concerned substances (Substances of Human Origin), which are supposed to be proportionate to the associated risks, the EU Commission also intends to promote innovative activities of companies.

Once adopted and implemented in all Member States, the proposed Regulation will replace the safety and quality rules laid down in two Directives (Directive 2002/98/EC for blood and blood components and Directive 2004/23/EC for tissues and cells) together with their implementing Regulations.

Stakeholders may submit their comments on the Commission’s proposal for a Regulation until 09 September.

Further information at: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12734-Blood-tissues-and-cells-for-medical-treatments-therapies-revised-EU-rules_en

Our blog contributions shall provide an overview with regard to legal topics, legislation and case law and are supposed to provide some general information rather than constituting any specific advice. Please do not hesitate to contact Maiwald and in particular the authors of the particular contributions if have any questions on the addressed topics or on other legal issues.

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Authors

Dr Gisela Grabow

Counsel

Lawyer (England/Wales)