The EU has developed a legislative framework, the ‘New Legislative Framework’ (NLF 2015), that is the legal basis for non-food product compliance legislation within the EU. This framework defines stakeholders and their obligations, ranging from the various roles in the supply chain to the role of the market surveillance authorities.
If you are not able to prove that your product is compliant, the authorities can demand you to recall the product, which not only is an expensive process, it also causes damage to your brand.
In relation to a product that is subject to Union harmonisation legislation, formal non-compliance with that legislation shall give market surveillance authorities sufficient reason to believe that the product may present a risk in any of the following cases:
(a) the CE marking or other markings required by Union harmonisation legislation have not been affixed or have been affixed incorrectly;
(b) the EU declaration of conformity, where required, has not been drawn up or has been drawn up incorrectly;
(c) the technical documentation is incomplete or unavailable;
(d) the required labelling or instructions for use are incomplete or missing.
Regardless whether the risk assessment shows that the product in fact presents a risk, market surveillance authorities shall require the economic operator to rectify the formal non-compliance. If the economic operator fails to do so, market surveillance authorities shall ensure that the product is withdrawn or recalled.