Stress free guide to product compliance

Regulation on Mutual Recognition of Goods

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

New Regulation in Mutual Recognition of Goods (MRG)

Per 19 April 2020 there is a new Regulation applicable regarding the Mutual Recognition of Goods (EU) 2019/515, replacing the previous Regulation on recognition of goods: (EC) 764/2008. This Regulation applies to goods of any type, including agricultural products, and to administrative decisions taken by a competent authority.

Why new rules on mutual recognition of goods?

After an evaluation of (EC) 764/2008, it was concluded that evidence required to demonstrate that goods are lawfully marketed in a Member State (MS), varies significantly from MS to MS. This inequality causes problems for companies, such as unnecessary burdens, delays and costs, for example for re-testing to proof compliance. The problems inhibit the EU principles of mutual recognition and free movement of goods.
In order to solve the problems, the EU announces:

  1. A voluntary Mutual Recognition Declaration;
  2. The ability to sell products during government assessment of already marketed goods;
  3. Strengthening the tasks of Product Contact Points.
  4. Problem solving by SOLVIT.

What does this mean?

In general it means that if goods are legally sold in one MS, another MS cannot prevent the placement of that goods on their market. Compliant products sold in one MS can be marketed in another MS using a Mutual Recognition Declaration (MRD). Products accompanied byaMRDmaybesoldintheEUmarket,evenifaMS assesses the goods for compliancy. There is one exception, a MS may have a prior authorisation procedure. However, such a procedure has to pursue a public interest objective recognised by Union law, and it has to be proportionate and non-discriminatory.

1. Mutual Recognition Declaration (MRD)

The producer of goods that wants to sell a product in another MS may now draw up a voluntary MRD to demonstrate to the authorities that the goods are lawfully marketed in the (first) MS. This MRD may also be made available online. The person who signs the MRD is responsible that the MRD is kept up to date with all applicable legislation. The MRD can, if applicable, be added to the Declaration of Compliance (DoC).
The EU has an online indicative list available that contains products not subject to Community harmonisation legislation. The list can be accessed here. A simple way te keep your product file and MRD up to date is by checking regularly the technical file in ProductIP.

2. Sell products during assessment

Under the previous legislation during a government assessment of marketed goods it was, on the whole, not allowed to sell the products during the assessment. Following (EU) 2019/515, if an MS wants to assess if the applicable national technical rules are adequately protected, it shall contact the 'economic operator'. If the goods are accompanied with a MRD, the goods are allowed to be placed on the market of the other MS during the assessment. Placement on the market can only be temporary suspended in case of a serious risk to health or environment or when the good is generally prohibited. The MRD and supporting documentation contains all the information the authority may require to make its assessment.

3. Product Contact Points

Each MS must designate a Product Contact Point (PCP). PCP's shall provide the following information online:
a. Information of mutual recognition
b. Contact details of competent authorities
c. Remedies and procedure available in case of a dispute (including SOLVIT, see point 4).

A PCP can provide information to economic operators on applicable national rules and the application of the principal of mutual recognition. The PCP should provide the economic operator with a free copy of the applicable legislation to the product. However, PCP's do not provide information on, copies of, or give online access to harmonised standards.

4. Problem solving by SOLVIT.

Even with a MRD, a problem can arise between a public authority and a company that wishes to sell a product on a MS market. To avoid costly legal procedures, the regulation promotes the use of SOLVIT, which is a non- judicial, problem-solving service desk that is provided free of charge. SOLVIT aims to find solutions for individuals and businesses when their EU-rights have been breached by public authorities in another MS. The objective is to find solutions within 10 weeks, starting on the day the case is taken on by the SOLVIT centre in the country where the problem occurred. SOLVIT has a direct line to the European Commission to ask for an opinion in solving the case (link to short video clip).

What do you need to do?

To benefit from this new legislation, we advise to do the following:

  1. Check per product you want to market in another MS your Technical File to verify that it is up-to-date to all applicable legislation. If this is not the case, this should be your first priority.
  2. When your product file is complete, draft a MRD and add this to the DoC (if applicable). For your convenience ProductIP has created a template that you can use.
  3. Start selling your product on the market of the other MS.

Conclusion

It has become much easier to market/sell your compliant goods on the EU-market. In order to benefit it is however become more important than ever to comply to all applicable legislation. If your ProductIP-file is complete, in 2020 ProductIP will offer a way to digitally generate a MRD, which you can sign digitally. However, you can already use our template!

printscreen of MRD template of ProductIP

Need more information?

ProductIP organises workshops on a regular basis. You will receive all information you need to work with this legislation. Check our website for more details and availability.


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