Find out more about the latest rules and regulations from Eurolab’s new policy update. New legislation laws address growing concerns with product and food safety, cybersecurity, counterfeit medicines and single-use plastics.
The Goods Package
The Council adopted the regulation on market surveillance in order to ensure that products placed on the market in the EU are safe and compliant with EU legislation. The regulation also ensures stricter enforcement of EU rules in an effort to increase consumers' confidence in products placed on the EU market. The Regulation will soon be published in the Official Journal and will enter into force soon after. Source European Council
Cybersecurity Act published on 7 June and will enter into force end of June. Source European Commission
CEN-CENELEC Focus Group Artificial Intelligence.
Beginning 2019, the Technical Boards of CEN and CENELEC have set up a Focus Group on Artificial Intelligence which held its first meeting in April 2019 in Copenhagen. The secretariat of the Focus Group is held by Danish Standards. The main objective of the Focus Group is to develop an AI standardization Roadmap for Europe.
The future is quantum: EU countries plan ultra-secure communication network
- Representatives of 7 EU countries (Belgium, Germany, Italy, Luxembourg, Malta, the Netherlands, and Spain) signed a declaration
- Explore how to develop and deploy a quantum communication infrastructure (QCI) across the EU within the next ten years.
- Information and data to be transmitted and stored ultra-securely, link communication assets all over the EU.
- Integration of quantum technologies and systems into conventional communication infrastructures Source: European Commission
The ECJ ruling on mutagenesis requires a change in EU GMO legislation.
22 EU food and feed chain organisations jointly signed a letter urging Member States and the EU Commission to ensure EU legislation allows EU operators of the food and feed chain to preserve access to competitive supply of innovative food and feed ingredients. On 25 July 2018, the European Court of Justice interpreted the provisions of the EU GMO Directive 2001/18 in such a way that products resulting from innovative, targeted mutagenesis methods are regulated under the provisions of the GMO-Directive. Source FEFAC
The use of whole genome sequencing can improve the way antimicrobial resistance (AMR) is monitored in food and animals, EFSA says in a new report. Ahead of the revised legislation on AMR monitoring that is due to come into force in 2021, EFSA suggests that these methods could gradually be introduced into Member State monitoring activities. Using whole genome sequencing, experts can identify resistant genes in bacteria as opposed to current phenotypical methods which test bacteria for resistance to specific antibiotics. Source EFSA
Europeans on today’s food issues: new EU-wide survey comes out on first World Food Safety Day. Two in 5 Europeans take a personal interest in food safety and only 1 in 5 say it is their main concern when choosing food. For most Europeans it is one of several factors - together with price, taste, nutrition and food origin – that influence their eating habits and food choices. These are some of the many insights from a new Eurobarometer survey by EFSA, published on the first ever World Food Safety Day on 7 June. Source EFSA
EFSA issues new advice on phosphates. Estimated total intake of phosphates from food may exceed the safe level set by EFSA after re-evaluating their safety. EFSA’s scientists also recommend the introduction of maximum permitted levels to reduce the content of phosphates when used as additives in food supplements as those who take them regularly may be at risk. Source EFSA
Counterfeit medicine a "growing threat" in Europe. According to a new study by EUIPO and Europol, counterfeit medicine is a "growing threat" in Europe causing serious illnesses, fatalities and costing the pharmaceutical industry billions every year. It found that criminal networks are producing an "increasingly diverse range of medicines", including drugs to treat serious illness including cancer. Source: EUIPO & Europol report; CNA
New Europol/EUIPO Threat Assessment Report confirms links between IP crime and organised crime in the EU. Most criminal activity involving counterfeiting is carried out by increasingly professionalised organised crime networks, which can reap large profits while running few risks. This is according to the first EU-wide intellectual property crime threat assessment by Europol and the EUIPO published on June 12 2019 during the International Forum on IP Enforcement in Paris, a forward-looking strategic analysis building on two previous joint situation reports on counterfeiting and piracy. Source EUIPO
Ban on single-use plastics set new global standard has been adopted by the European Council. It will son be published in the Official Journal of the European Union. The Directive will enter into force 20 days after the publication. The Member States will then have two years to transpose the legislation into their national law. The Directive has differentiated dates for transposition bans and the marking obligations, tethered caps and lids for beverage containers up to 3 litres Source: European Commission
The Commission shared with Member States the successful outcome of the negotiations to review the functioning of an existing quota to import hormone-free beef into the EU. Based on a Council's mandate, the Commission reached an agreement in principle with the United States and other substantial supplying countries that 35,000 tonnes of this quota will be allocated to the U.S., phased over a 7 years period, with the remaining amount left available for all other exporters. Source European Commission
MedTech Europe has published its position on the European Commission Standardisation Request for the IVD and MD Regulations. MedTech Europe’s position paper aims at outlining several concerns including limited flexibility, resourcing and expected timing of the harmonisation process. Therefore, MedTech Europe calls upon Member States, Notified Bodies and National Standards Organisations to support the integrity of healthcare system by raising these concerns to the European Commission. Source: MedTech Europe
European database on medical devices (EUDAMED) The European Commission has recently set up a new webpage to collect information that is related to the implementation of the upcoming European database on medical devices (EUDAMED). The website is expected to be updated regularly upon new implementation documents are finalised. Source: MedTech Europe
The initiative on linking genomic databases across borders has been signed by Norway. Member States of the EU, the European Economic Area (EEA) and the European Free Trade Association (EFTA) have committed to collaborate on the secure and authorised access to national and regional banks of genomic and other health related data. Source European Commission.