By Joerg Gruenwald, analyze & realize ag06.02.21
The mutual recognition principle ensures market access for goods that are not, or only partly, subject to EU harmonization legislation. It guarantees that any good lawfully sold in one EU country can be sold in another. This is possible even if the good in question does not fully comply with the technical rules of the other country (although there may be exceptions where public safety, health, or the environment are concerned).
The principle stems from Articles 34-36 of the Treaty on the Functioning of the European Union (TFEU) and is further defined in Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another country. It defines the rights and obligations in relation to the mutual recognition principle for competent authorities and businesses when selling goods in another EU country.
A voluntary “mutual recognition declaration,” which businesses can use to demonstrate that their products are lawfully marketed in another EU country, is included in the regulation. A practical “advice on mutual recognition declaration” is also available.
Especially in the case of botanicals, where national legislation on what plants are or are not allowed to be used in food varies from country to country, this principle can ensure market access where individual notification applications might fail.
SOLVIT May Help
However, it is still possible that even mutual recognition does not yield the desired results. In cases where an application for mutual recognition for a product has been refused because the respective member state considers there to be a risk to public safety, health, or the environment, but the food business operator in question disagrees, SOLVIT can help. SOLVIT is a service provided free of charge by the national administration in each EU country and in Iceland, Liechtenstein, and Norway. It is available to businesses and to consumers.
Issues can be submitted to SOLVIT in the country where the product in question is legally marketed—the SOLVIT home center. The home center then gets in touch with its counterpart in the other respective EU country, in this case the country where the mutual recognition application was refused—the SOLVIT lead center.
Within one week, the lead center will contact the FBO to let them know whether they will accept the case. If they do, they will then contact the responsible authority of the respective member state where the problem occurred and try to find a solution for the problem.
A solution-finding principle based on SOLVIT is included in the mutual recognition regulation. It includes the possibility of an assessment from the EU Commission on the compatibility of a decision restricting or denying market access with EU law.
Currently, the EU Commission is striving to make the principle of mutual recognition more accessible to food business operators wishing to market their products in more than one EU country. The EU Commission is offering training on mutual recognition and has published additional information and documents such as “product contact points” that are established in each EU country to provide free advice related to the mutual recognition regulation within 15 working days.
High Hurdles?
In theory, mutual recognition might also be a way around the current EU-wide ban of the words “probiotic” and “prebiotic.” Once a product using these terms on its labels has been legally notified in a country that has lifted this ban (e.g., in Italy), it should be possible to apply for mutual recognition for this product in all other EU countries. In practice, however, analyze & realize GmbH is not aware of any case where mutual recognition was applied to get around product labeling issues.
One of the disadvantages of mutual recognition is that, once such an attempt (and SOLVIT) has failed, the product in question is not allowed to be marketed in the country that refused mutual recognition. Therefore, FBOs should always be aware of the height of the hurdles to be overcome, so that they can estimate the risk involved. Some EU countries are more restrictive than others. Some have turned upper limits of nutrients or permitted botanicals into national legislation; some have merely published recommendations. Experienced consultancies such as analyze & realize can help navigate these regulatory waters.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@a-r.com; Website: www.analyze-realize.com.
The principle stems from Articles 34-36 of the Treaty on the Functioning of the European Union (TFEU) and is further defined in Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another country. It defines the rights and obligations in relation to the mutual recognition principle for competent authorities and businesses when selling goods in another EU country.
A voluntary “mutual recognition declaration,” which businesses can use to demonstrate that their products are lawfully marketed in another EU country, is included in the regulation. A practical “advice on mutual recognition declaration” is also available.
Especially in the case of botanicals, where national legislation on what plants are or are not allowed to be used in food varies from country to country, this principle can ensure market access where individual notification applications might fail.
SOLVIT May Help
However, it is still possible that even mutual recognition does not yield the desired results. In cases where an application for mutual recognition for a product has been refused because the respective member state considers there to be a risk to public safety, health, or the environment, but the food business operator in question disagrees, SOLVIT can help. SOLVIT is a service provided free of charge by the national administration in each EU country and in Iceland, Liechtenstein, and Norway. It is available to businesses and to consumers.
Issues can be submitted to SOLVIT in the country where the product in question is legally marketed—the SOLVIT home center. The home center then gets in touch with its counterpart in the other respective EU country, in this case the country where the mutual recognition application was refused—the SOLVIT lead center.
Within one week, the lead center will contact the FBO to let them know whether they will accept the case. If they do, they will then contact the responsible authority of the respective member state where the problem occurred and try to find a solution for the problem.
A solution-finding principle based on SOLVIT is included in the mutual recognition regulation. It includes the possibility of an assessment from the EU Commission on the compatibility of a decision restricting or denying market access with EU law.
Currently, the EU Commission is striving to make the principle of mutual recognition more accessible to food business operators wishing to market their products in more than one EU country. The EU Commission is offering training on mutual recognition and has published additional information and documents such as “product contact points” that are established in each EU country to provide free advice related to the mutual recognition regulation within 15 working days.
High Hurdles?
In theory, mutual recognition might also be a way around the current EU-wide ban of the words “probiotic” and “prebiotic.” Once a product using these terms on its labels has been legally notified in a country that has lifted this ban (e.g., in Italy), it should be possible to apply for mutual recognition for this product in all other EU countries. In practice, however, analyze & realize GmbH is not aware of any case where mutual recognition was applied to get around product labeling issues.
One of the disadvantages of mutual recognition is that, once such an attempt (and SOLVIT) has failed, the product in question is not allowed to be marketed in the country that refused mutual recognition. Therefore, FBOs should always be aware of the height of the hurdles to be overcome, so that they can estimate the risk involved. Some EU countries are more restrictive than others. Some have turned upper limits of nutrients or permitted botanicals into national legislation; some have merely published recommendations. Experienced consultancies such as analyze & realize can help navigate these regulatory waters.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@a-r.com; Website: www.analyze-realize.com.
