Products that are not or not completely covered by European harmonisation regulations are subject to the free movement of goods pursuant to Art. 28 et seq. TFEU (see in particular Art. 34 TFEU) and thus the principle of mutual recognition. If a product has been lawfully placed on the market in one Member State, its sale in another Member State may not, in principle, be prohibited. This also applies if the technical regulations according to which the product was manufactured differ from those of the importing state.

Exceptions are only possible in the case of restrictions based on the grounds listed in Art. 36 TFEU or other overriding reasons in the public interest as defined by the case law of the European Court of Justice. Such restrictions must also comply with the principle of proportionality.

Details on the application of the principle of mutual recognition are regulated by Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another Member State. The Regulation deals in particular with procedures.

The following situations are to be distinguished:

1.    prior authorisation procedure

The opening of market access for certain goods is sometimes made dependent on an authorisation to be granted (prior authorisation procedure). The admissibility of this requirement has to be assessed on a case-by-case basis in compliance with the prohibition of discrimination and in strict compliance with the principle of proportionality. Regulation 2019/515 does not preclude the implementation of prior authorisation procedures. If goods for which an authorisation requirement exists are placed on the market without authorisation, an official prohibition order based on this does not lead to the opening of the procedural rights of the Regulation. In cases where a requested authorisation is refused, see point 3 below.

2.  evaluation of goods according to the Regulation 2019/515

In individual cases, market surveillance authorities carry out test procedures to assess goods. The aim is to determine whether the goods were lawfully placed on the market in another Member State or whether justified general interests covered by a national technical regulation applicable in Germany exceptionally justify a restriction of market access. The opening of an assessment procedure according to Art. 5 of Regulation 2019/515 does not prevent market access in principle. The competent authority shall notify the undertaking concerned of the intention to carry out an assessment procedure without delay.  

If, in the course of the procedure, the authority takes an administrative decision pursuant to Art. 5(9) of the Regulation to restrict or refuse market access, it must inform the undertaking concerned without delay and notify the Commission and the other Member States within 20 working days. The company concerned, the Commission and the Member States must also be informed without delay if the authority exceptionally takes measures to temporarily suspend the market access of a product during the evaluation procedure (Art. 6 Regulation 2019/515). For the purposes of information and notification in the assessment procedure, the competent authority must use the electronic information communication system ICSMS according to Regulation (EC) No 765/2008 (Market Surveillance Regulation) pursuant to Art. 11 of Regulation 2019/515.

3.  assessment of goods under Regulation 2019/515 in the context of a prior authorisation procedure

If the competent authority refuses to grant the requested authorisation in a prior authorisation procedure and justifies this with a conflicting national technical regulation, the decision to refuse authorisation is deemed to be an administrative decision according to Article 5(9) of Regulation 2019/515. The scope of application of Regulation 2019/515 is opened for this constellation of the prior authorisation procedure. Thus, the information and notification obligations mentioned under point 2. must also be observed.

 

The Regulation also introduced a voluntary, standardised self-declaration for companies (Art. 4 Regulation 2019/515). This is intended to make it easier for companies to rely on the lawful placing on the market of a product in another EU Member State (MS). The self-declaration as well as the evidence required for the verification of the information contained in the declaration, which was submitted upon request by the competent authority, are accepted as sufficient proof of the lawful placing on the market in the context of the assessment of a product (Art. 5(4) of Regulation 2019/515).

Furthermore, Art. 8 of Regulation 2019/515 now explicitly provides for the use of the SOLVIT network as a problem-solving mechanism in cases of dispute. The authority must explicitly refer to this in a decision concluding the assessment procedure (Art. 5 para. 12 sentence 2 of Regulation 2019/515).