2017 Begins with Flurry of Regulatory Activity in European Union

April 21, 2017Kirsten Wallerstedt and Scott Stephens

Since the beginning of 2017, the EU has harmonized information for poison centers, Britain formally invoked Article 50 to leave the EU, SVHCs are proposed to be targeted in the waste directive, conflict minerals is one step from becoming official, and a new medical devices framework is moving forward.

EU Harmonizes Emergency Information Requirements on Mixtures for Submission to Poison Centers
The European Commission has adopted legislation that amends the Classification, Labeling and Packaging Regulation (CLP – 1272/2008/EC) by harmonizing the emergency health response information that importers and downstream users placing mixtures on the market must submit to national poison centers. 

UK Submits Article 50 Letter to Formally Begin Process of Leaving the European Union              
On 29 March 2017, the Prime Minister of the United Kingdom (UK) submitted the letter to the European Council President formally declaring the UK's intention to leave the European Union (EU) by triggering Article 50 of the Treaty on European Union, "Withdrawal of a Member State from the EU." Among the points in the letter, Prime Minister Theresa May states the intent to convert EU law into UK law, in particular to ensure continuity for businesses. It also proposes a Free Trade Agreement between the EU and UK. Formal negotiations may now begin and will last two years from the date of the letter, at which time the UK will become formally severed from the EU.

Amendments to EU Waste Directive Propose to Progressively Target SVHCs  
On 14 March 2017, the European Parliament adopted additional amendments to the proposal for a directive of the European Parliament and of the Council amending Directive 2008/98/EC on waste (Waste Framework Directive). The amendments would, among other things, direct member states to develop non-toxic material cycles so that recycled waste can be used as a source of raw materials for the Union. The matter is now referred back to the Committee on the Environment, Public Health and Food Safety (ENVI) to allow for inter-institutional negotiations.

EU Parliament Approves Conflict Minerals Regulation
On 3 April 2017, the Council formally approved the Regulation that will require importers into the EU of tin, gold, tantalum and tungsten (3TG) to perform mandatory due diligence checks on their supply chain. The Regulation was approved by the Parliament in March. The goal is to mitigate the risk that the trade of 3TG funded armed groups or human rights abuses in conflict areas around the world. The effective date of the regulation will coincide with its publication in the Official Journal of the EU. Businesses will be required to comply with the new requirements by 2021.

European Union Moves Forward on Medical Devices Regulation
On 8 March 2017, the Council released its position supporting the adoption of two Regulations which together will overhaul the medical device regulatory framework in the EU. The texts now go to the Parliament for a joint debate and then a final vote, which is expected to take place on 21 March 2017. The Regulations are expected to enter into force in mid-2017, with the new rules becoming enforceable in 2020 for medical devices and in 2022 for in vitro diagnostics.

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