take-e-way News and Press Releases

Distributors of e-cigarettes must always ensure that all ingredients they contain are known and declared. Germany’s state investigation offices carry out random checks in this regard. Recommendation: Not only does e-cigarette hardware need to be marketed in full legal compliance; special attention must also be paid to the liquids used.

A simplified test procedure for the approval of PPE masks as medical masks has already been in place since the corona pandemic began. The Central Office of the Federal States for Safety Technology (ZLS) has now published a new revision of the test procedure with the issue date 2 June 2020. The new features include additional criteria for labelling the masks. TMK Retail Service & Consulting GmbH will support you in selecting a suitable market access procedure and evaluating the necessary documentation.

Up until now, it has been possible to market dust protective breathing masks with test certificates for FFP2, KN95 or N95 as medical devices for customers in the healthcare sector by special approval from the Federal Institute for Drugs and Medical Devices (BfArM). According to the BfArM, many masks were unfortunately put into circulation via this route with the aid of forged certificates that fail to meet what they promise. In addition, the market is once again sufficiently supplied with regularly certified masks, which means that special approval will only be granted for masks for which a test certificate in conformity the corona test procedures of the Central Office of the Federal States for Safety Technology (ZLS) is in hand. Accordingly, for the time being KN95 or N95 respiratory masks are no longer marketable as medical devices without verification. TMK Retail Service & Consulting GmbH supports you by reviewing the available documents, estimating the costs and selecting possible market access.

The previous obligation to notify the German Federal Environment Agency (UBA) will be replaced by mandatory registration for manufacturers of device, automotive and industrial batteries. The task of registering manufacturers will be performed by the EAR foundation (German WEEE registration board) on being commissioned to do so by the UBA. From take-e-way’s perspective, it is therefore conceivable that the enforcement of the Batteries Act from 2021 will be regulated as efficiently as under the German Electrical and Electronic Equipment Act. Distributors, importers and manufacturers who have not yet registered their batteries and accumulators should take action now, without any further delay.

For new players in the protective clothing market, but also for those who plan to market new products, professional preparation to meet the legal requirements in force is important. TMK Retail Service & Consulting GmbH supports you with research on the legal requirements as well as with the normative implementation.

Notifications submitted after 30 April 2020 – which are actually late – will therefore not be forwarded (in coordination with) the Federal Environment Agency as the authority responsible for the prosecution of administrative offences.

Children also want to be protected in corona times. Poorly fitting FFP2 or medical masks often provide worse protection than specially adapted fabric masks (referred to as community masks). It is important in this regard, however, to observe the specific safety requirements for children. In addition to the increased requirements for the absence of harmful substances in the materials, the mask in question must also be mechanically safe. Easily detachable small parts as well as incorrect lengths of the fastening cords can be life-threatening! Recommendation: The relevant safety standards should be observed in the manufacture of children’s masks.

Dealers are obliged to provide essential information necessary for use and operation of products before customers take a purchase decision. Accordingly, dealers are obliged to point out the essential circumstances during installation and operation of the goods offered. By means of its service for establishing the marketability of products, TMK Retail Service & Consulting GmbH adapts your product and packaging markings as well as your operating instructions in accordance with the statutory requirements applicable.

The German Foundation Central Agency Packaging Register (ZSVR) has published various very helpful theme papers on its website. Differentiated according to industry sectors – especially for retail companies, mail order companies, online retailers and micro distributors.

The current crisis situation has resulted in huge demand for respiratory masks. Yet the task of importing such masks involves a complicated procedure. As a result, some products have entered the European market that do not deliver what they promise, as can be seen in the latest reports on the RAPEX list. RAPEX stands for the European rapid alert system providing for dangerous and non-marketable products to be listed – often resulting in the relevant products having to be recalled. In order to ensure that imports proceed smoothly, a few important points need to be considered, which we have compiled for you here.