Ref. Ares(2022)6720486 - 29/09/2022
Communication from the Commission - TRIS/(2022) 03184
Directive (EU) 2015/1535
Translation of the message 103
Forwarding of the observations of a Member State (Spain) (article 5, paragraph 2, of Directive (EU) 2015/1535).
These observations do not have the effect of extending the standstill period.
1. MSG 104 IND 2022 0395 S EN 08-09-2022 05-09-2022 COM 5.2 08-09-2022
3A. Ministerio de Asuntos Exteriores, Unión Europea y Cooperación
Dirección General de Coordinación del Mercado Interior y Otras Políticas Comunitarias
Subdirección General de Asuntos Industriales, Energéticos, de Transportes y Comunicaciones, y de Medio
Plaza Marqués de Salamanca 8, 28006 Madrid
Teléfonos: 91 379 84 64, 91 379 83 87 y 91 379 83 98
3B. Comisión Interministerial para la Ordenación Alimentaria
Agencia Española de Seguridad Alimentaria y Nutrición.
Ministerio de Consumo.
4. 2022/0395/S - C80A
5. article 5, paragraph 2, of Directive (EU) 2015/1535
6. Notification No 2022/395/S
Within the framework of Directive (EU) 2015/535, Sweden notified, on 7 June 2022, the draft Regulation of the
Swedish Food Agency on food supplements.
This draft, once adopted, will replace the Regulation currently in force that transposed Directive 2002/46/EC on
the approximation of the laws of the Member States relating to food supplements.
The Notification states that, in accordance with Directive 2002/46/EC, the Commission is empowered to establish
maximum levels of vitamins and minerals in food supplements. However, to date, there has been no decision in
this regard. Therefore, on grounds of consumer health protection, the Swedish Food Agency has chosen to
introduce national maximum levels of vitamin D and iodine, which have been incorporated in Articles 11 to 13 of the
notified draft Regulation. They are expected to apply from 1 January 2024.
Following the analysis of this draft, Spain would like to ask Sweden for clarification on some of the issues
contained in the Regulation in question. In particular, it is considered necessary for the Swedish authorities to
provide substantiated justification for the reasons why the maximum levels established in this draft are not
consistent with those recommended by EFSA. In the case of vitamin D, a maximum permitted limit of 80 μg is set,
while EFSA recommends 100 μg. In the case of iodine, the maximum permitted quantity is 200 μg, while the
amount recommended by EFSA is 600 μg. In addition, it is noted that the Swedish draft does not contain a Mutual
Recognition Clause and therefore an explanation in this regard is also considered necessary.
In Spain’s view, the establishment of maximum levels of iodine and vitamin D content in food supplements other
than those recommended by EFSA, which are commonly used in many Member States, together with the lack of a
mutual recognition clause in this draft Regulation, will de facto constitute an unjustified obstacle to the free
movement of goods referred to in Article 34 of the TFEU. In accordance with the current wording of this draft, the
only possibility of placing food supplements produced in other Member States on the market in Sweden is to
comply with the limits set out therein, which would make it necessary to reformulate their composition and to have
labelling expressly adapted to the Swedish market, at the additional cost that this would entail.
The Swedish authorities are therefore urged to take these observations into account and to carry out the
appropriate amendments in order to prevent this legislation from becoming an unnecessary obstacle to
intra-Community trade in food supplements.
Madrid, 2 September 2022
Contact point Directive (EU) 2015/1535
Fax: +32 229 98043