Product safety law

The European free movement of goods benefits only those placing marketable goods on the market. Satisfaction of the requirements for marketability – mostly multi-layered - can be summarised under the term of Product Compliance, which means that the product is in such a condition that no occasion for complaints by the market surveillance authorities arises. Core elements of Product Compliance are, firstly, ascertaining the requirements applicable in the specific case and secondly, reviewing whether the product concerned conforms to the ascertained catalogue of requirements.

Within the genuine legal review, distinction is made between formal and material requirements for marketability, the formal not being safety-relevant, the material, however, being safety-relevant. Many difficult legal questions, above all with close reference to labelling law (e.g. with the manufacturer’s data, identification marks or CE marking), arise in particular in connection with the formal requirements. Equally central is also determining the safety of the product as a material requirement on products in the case of which the businesses must take into account different legal provisions.

We advise comprehensively on Product Compliance in the non-food area i.e. especially on
  • general product safety law,
  • low voltage law,
  • machinery law,
  • toys law,
  • personal protective equipment law,
  • electromagnetic compatibility law,
  • radio equipment law,
  • building products law,
  • consumer goods law,
  • food consumer goods law,
  • ATEX law,
  • public roads admission law,
  • pressure equipment law,
  • lift law,
  • pyrothecnic law,
  • calibration law, and
  • sports boat law.
If a European or German market surveillance authority complains about a product because of alleged lack of marketability, considerable consequences for the affected business can follow, since the sale of the product concerned in all European sales regions is automatically threatened. Anticipated turnover and profit in the planned or necessary extent may no longer be achievable against that background.

Based on our market surveillance experience, we support our clients in that scenario in the ongoing market surveillance proceedings in order to prevent the imposition of market surveillance measures. If necessary and advisable, we defend the impugned product including before the administrative court having jurisdiction with the aim of having the basic sales prohibition of the market surveillance authority reversed. Overall, we know how to deploy comprehensive cooperation and, if the case so requires, confrontation over the available range of European market surveillance law so that our client can provide its marketable and/or safe (volume) products as rapidly as possible unhindered on the target market.
Regrettably, in practice it occasionally happens that the customs authorities unjustly seize products imported into the European Economic Area (EEA) and/or the European Union (EU). That often arises with precisely completely new or innovative products which should reach the market rapidly.

In that crisis situation for any business affected, rapid and skilful action is required in order to achieve the release of the marketable goods from the customs as quickly as possible. Because of many years‘ experience in customs disputes, we know where to intervene in order to arrive rapidly at a reasonable solution (=release) for our client with the customs and market surveillance authorities.
Product safety law is a very dynamic legal area. Especially at EU level, there are continuously new legislative acts (Regulations and Directives) or proposals for the issue of such legislative acts in circulation. Decisions and announcements of the European Commission can be added, creating a scarcely manageable overall picture.

As legal advisors in tune with the times, we offer our clients newsletters with tailored scope. The objective is to inform our clients at an early stage of all legal developments in product law relevant to them. Typically, we differentiate between short-term, medium-term and long-term legal developments to be observed. Amendments which should be placed on the internal company agenda without delay are thereby immediately highlighted.
If a product problem is indicated, a risk assessment is advisable. The purpose of a risk assessment is firstly, the identification of the product risk concerned. Based on our many years‘ professional practice, we have comprehensive experience of the preparation of risk assessments according to the RAPEX guidelines, both for consumer products and non-consumer products and/or technical work equipment. Secondly, the risk assessment serves the purpose of simultaneously preparing intelligible documentation for the market surveillance. If product risks subject to notification arise, the market surveillance authority having jurisdiction must be contacted for the purpose of the notification and/or official notice. From experience, it is especially helpful in that event if the notifying enterprise can at the same time make a final RAPEX risk assessment available to the market surveillance authority.

The preparation of the risk assessment requires cooperation between technology on the one hand and law on the other. In practice, engineers and technicians from the client working together with us as specialised lawyers functions very well. As lawyers steeped in technology law, we understand the technical language of our clients and employ it as sparring partner in a legally reliable risk assessment. At the same time, our work on the risk assessment aims at a final work product (= the completed risk assessment) which is understood in detail by our client.
Accreditation and certification law have been a central element in European product safety law for a long time. From a legal point of view, it is closely associated with conformity assessment law, according to which the manufacturer of European harmonised products is obliged without exception to use a specific module e.g. the internal production control (module A); or the CE type-examination (module B) to determine conformity. The relevant conformity assessment procedure should in each case cover the design and production phase as well. The central foundations for the applicable accreditation and certification law are at EU level Regulation (EC) No. 765/2008 and Decision No. 768/2008/EC as well as, at national level, the Act on the Accreditation Body (Akkreditierungsstellengesetz – AkkStelleG).

We advise, with our specific expertise in accreditation and certification law, in particular notified bodies and economic operators (especially manufacturers and quasi-manufacturers) on all legal questions arising. We prepare for our clients, above all, legal reports on the interpretation of individual legal provisions in accreditation and certification law. In addition, we support our clients in any disputes with other parties (out-of-court and, as the case may be, in court).
Technical work safety law deals with the protection of workers from health hazards arising from the use of technology in the production process. In turn, preventative (product-related) work safety through work materials safety law, in Germany derived from the Industrial Safety Regulation, is a central element of technical work safety which dovetails with applicable product safety law. Our advice aims at work safety law Compliance in all questions of technical work safety. In that context, we advise our clients in particular on the following work safety elements:
  • Safety and Health at Work law (ArbSchG - Safety and Health at Work Act)
  • Industrial Safety law (BetrSichV - Industrial Safety Regulation) with Work Equipment Safety law and Industrial Plant Safety law (law of Plants subject to Supervision)
  • Work Place law (ArbStättV - Workplace Regulation)
  • Work Safety law (ASiG - Work Safety Act)
  • Organisation and Delegation issues (§§ 3, 13 ArbSchG)
  • Law of danger assessment
  • Law of Directions