Blog - Page 9 of 14 - Die Produktkanzlei

16. December 2021 Prof. Dr. Boris Handorn

New Implementing Regulation as regards electronic instructions for use of medical devices – just old wine in new bottles?

On 15.12.2021, the Implementing Regulation (EU) 2021/2226 laying down detailed rules for the implementation of Regulation (EU) 2017/745 with regard to electronic instructions for use of medical devices was published.

8. December 2021 Dr. Carsten Schucht

Proposal for uniform charging cables at EU level

On 23.09.2021, the EU Commission published a proposal to amend Directive 2014/53/EU (Radio Equipment Directive). This proposal aims to limit the fragmentation for charging interfaces and charging communication protocols, to improve consumer convenience and to reduce electronic waste.

30. November 2021 Martin Ahlhaus

REACH: New authorization requirements for certain phthalates in medical devices, food contact materials and packaging of medicinal products

With Regulation (EU) 2021/2045 (OJ EU L 418, 24.11.2021, p. 6), the EU Commission has implemented an extension of the entries in Annex XIV to Regulation (EC) No. 1907/2006 (REACH). The four phthalates bis(2-ethylhexyl)phthalate (DEHP, EC: 204-211-0, CAS: 117-81-7), benzyl butyl phthalate (BBP, EC: 201-622-7, CAS: 85-68-7), dibutyl phthalate (DBP, EC: 201-557-4, CAS: 84-74-2) and diisobutyl phthalate (DIBP, EC: 201-557-4, CAS: 84-74-2) have already been subject to authorization obligations.

25. November 2021 Michael Öttinger

Coalition Agreement of the “Ampel” – Impact on product law

On 24.11.2021, the coalition agreement of the new German Federal Government consisting of SPD, BÜNDNIS 90/DIE GRÜNEN and FDP with the title “Mehr Fortschritt wagen – Bündnis für Freiheit, Gerechtigkeit und Nachhaltigkeit” was published. Concrete product law topics are mainly expressed with regard to the IT sector, sustainability and consumer protection.

16. November 2021 Michael Öttinger

New exemptions added to Annex IV RoHS

On 15.11.2021, three Delegated Directives were published in the Official Journal of the EU, introducing three new exemptions from the substance restrictions of Directive 2011/65/EU (RoHS) with retroactive effect to 21.07.2021. The new exemptions relate exclusively to medical devices.

3. November 2021 Michael Öttinger

Draft European Battery Regulation – Overview and Forecast

The draft of a European Regulation concerning batteries and waste batteries and repealing Battery Directive 2006/66/EC was already published by the EU Commission in December 2020, but now the critical voices are increasing. The draft’s life-cycle regulation is an unprecedented approach in European product law and raises many questions due to numerous technical, structural and content-related deficits that urgently need to be clarified before adoption.

21. October 2021 Dr. Gerhard Wiebe

Product law requirements for smart textiles – manufacturer obligations and liability risks

So far there is no specific legal framework for the product area of smart textiles or smart clothes. This creates a certain degree of uncertainty among manufacturers and acts as an obstacle to development. However, a closer look shows that the existing legal situation enables a legally secure development, production and subsequent distribution of textiles 4.0.

14. September 2021 Martin Ahlhaus

SCIP database published

As of 14.09.2021, the European Chemicals Agency (ECHA) has granted public access to the so-called SCIP database. Buyers and consumers can use this to access information on substances of very high concern in articles.
According to ECHA, the database currently contains entries from more than 6,000 companies and notifications for more than four million articles. The database can be searched for the article using the article name, brand, category or material type, among others.

9. August 2021 Dr. Gerhard Wiebe

From 01.09.2021: Start of applicability of the EU regulations on ecodesign and energy labels for light sources

From 01.09.2021, the two practically relevant regulations on ecodesign and energy labels for lighting products shall apply. The ecodesign legislation in the form of Regulation (EU) 2019/2020 sets out requirements for the environmentally compatible design of light sources. Regulation (EU) 2019/2015, on the other hand, regulates the energy consumption labelling of light sources; it thus enables consumers to make a comparison with regard to energy consumption and serves as an orientation aid when making a purchase decision. For manufacturers, importers and retailers, 01.09.2021 marks an important point in time, as new requirements and obligations will be imposed on them.

19. July 2021 Michael Öttinger

Supply Chain Act – Final version includes relevant changes in detail

The version of the so-called Supply Chain Act finally passed by the German Bundesrat on 25.06.2021 definitely contains relevant changes compared to the numerous previous versions. These changes will be presented in this article.