News

in European Law

Emergency measures in response to outbreaks of highly pathogenic avian influenza in certain Member States

On 6 September 2022, the European Commission adopted Implementing Decision (EU) 2022/1483 in response to new outbreaks of Highly Pathogenic Avian Influence (HPAI) in regions of many Member States in the European Union. This disease poses a high risk to poultry farming and trade. In this Decision, the European Commission approves disease control measures that […]

in European Law

Implementation Regulation (EU) 2022/1492, adding L-valine as an authorised feed additive

Food Law Authorization of L-valine produced by Escherichia coli CCTCC M2020321 as a feed additive for all animal species On 8 September 2022, the European Commission adopted Implementing Regulation (EU) 2022/1492, adding an amino acid strain of Escherichia coli called L-valine to the list of authorized feed additives for animals in Regulation (EC) 1831/2003. This Regulation […]

in European Law

Environmental law – aquaculture sector

Council approves conclusions on the new aquaculture strategic guidelines for a more sustainable, resilient and competitive aquaculture sector On 18 July 2022 the Agriculture and Fisheries Council endorsed  the European Commission’s guidelines for more sustainable aquaculture in the EU for the 2021- 2030 period. These guidelines update administrative procedures to adapt them to more alleged […]

in European Law

COMMISSION REGULATION (EU) amending Regulation (EU) No 68/2013 on the Catalogue of feed materials

On 1 July 2022 the European Commission adopted Regulation 2022/4474 which replaces the Annex to Regulation (EU) No 68/2013 on the catalogue of feed materials. The new annex details the products and co-products obtained by fermentation and includes information reflecting different fermentation products. Additionally, feed materials labeled before the amendments to this Regulation may be […]

in European Law

Updated – Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

A guideline has been published by the European Medicines Agency regarding clinical trials on medicinal products for human use. This guideline is linked to Regulation (EU) No. 536/2014 and repealing Directive 2001/20/EC. This guideline outlines the documentation requirements on the biological, chemical, and pharmaceutical quality of investigational medicinal products (IMPs) containing biological and biotechnology derived […]

in European Law

Study on Health Data, Digital Health, and Artificial Intelligence in Healthcare

The European Commission has published a study on health data, digital health and artificial intelligence in healthcare. The study is aimed at providing information that will allow the European Commission to make informed policies in the areas of: digital health products and services, artificial intelligence in health, governing the use of health data and evaluating […]

in European Law

ePrescription and eDispensation of Authorised Medicinal Products – Guidelines on the electronic exchange of health data under Cross-Border Directive 2011/24/EU

On 10 June 2022, the eHealth Network published a guideline on the electronic exchange of health data under Cross-Border Directive 2011/24/EU. The eHealth Network was established under Directive 2011/14/EU and sets up a voluntary network of Member States’ authorities working with eHealth. The guideline supports the ePrescription and eDispensation of authorised medicinal products for patients […]

in European Law

Intellectual property: Commission issues a Proposal for protection of European Union craft and industrial products

On 13 April 2022, the European Commission issued a Proposed framework regulation “to protect the intellectual property for craft and industrial products that rely on the originality and authenticity of traditional practices from their regions.” The proposal establishes intellectual property protections, creates a two-step application process for geographical indication (GI) involving approval from both the […]

in European Law

Proposal for a regulation regarding temporary importation of seven products from Moldova

The European Commission proposed a regulation on 9 June 2022 to allow for “temporary improved market access for the remaining seven products from Moldova which are still subject to tariff rate quotas when entering the EU.” The seven products are plums, table grapes, apples, tomatoes, garlic, cherries, and grape juice. The regulation serves as an […]

in European Law

Health and Food – highly pathogenic avian influenza (HPAI)

The Council of the EU released a notification on 24 May 2022 that the Council’s Working Party on Animals and Veterinary approved conclusions on a “strategic approach for the development of vaccination as a complementary tool for the prevention and control” of highly pathogenic avian influenza (HPAI), an epizootic. Conclusions do not have legal effects. […]

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