Case C-299/12, Green-Swan Pharmaceuticals – a forbidden health claim benefiting from a transitional exception? [judgment 2013, ECLI:EU:C:2013:501]

Can the wording on the packaging of a trade marked food supplement for women in the menopause benefit from a transitional exception to EU Regulation 1924/2006 which regulates the health claims made on foods?

Facts
GS Merilin is a product sold to women in the menopause. It is a trade marked food supplement. Green-Swan Pharmaceuticals put GS Merilin on the market in the Czech Republic. In 2010, the packaging on GS Merilin was worded: ‘The preparation also contains calcium and Vitamin D3, which help to reduce a risk factor in the development of osteoporosis and fractures’.

According to the Czech Agriculture and Food Inspection Authority, this wording constituted a health claim that did not comply with EU Regulation 1924/2006. The company had committed a criminal act punishable by a fine of 200 000 Kč (CZK).

Green-Swan Pharmaceuticals disagreed. It noted that the wording of Article 28(2) of the EU Regulation states: ‘Products bearing trade marks or brand names existing before 1 January 2005 which do not comply with this Regulation may continue to be marketed until 19 January 2022 after which time the provisions of this Regulation shall apply’. Since GS Merilin had been trade marked in 2003 and had been put on the market before 2005, the product and the claim made on the packaging would not be affected by the EU Regulation until 19 January 2022.

Furthermore, Green-Swan took the view that the wording on the packaging did not fall foul of Article 2(2)(6) of the EU Regulation which relates to claims made about food that reduces the risks of a disease. The specific subsection of the EU Regulation defines a ‘reduction of disease risk claim’ as ‘any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease’. In Green-Swan’s view, the wording on the packaging neither suggested nor implied that taking GS Merilin would lead to a ‘significant’ reduction in the risk of developing osteoporosis and fractures.

Questions Referred
According to the website of the UK IPO, the Czech Supreme Administrative Court has asked the following questions:

1. Is the following health claim: ‘The preparation also contains calcium and Vitamin D3, which help to reduce a risk factor in the development of osteoporosis and fractures’, a reduction of disease risk claim within the meaning of Article 2(2)(6) of Regulation (EC) No 1924/2006 of 20 December 2006 on nutrition and health claims made on foods, as amended by Commission Regulation (EU) No 116/2010 of 9 February 2010, even though it is not expressly implied in this claim that the consumption of that preparation would significantly reduce a risk factor in the development of disease mentioned?

2. Does the concept of a trade mark or brand name within the meaning of Article 28(2) of Regulation (EC) No 1924/2006 of 20 December 2006 on nutrition and health claims made on foods, as amended by Commission Regulation (EU) No 116/2010 of 9 February 2010, also include a commercial communication on the packaging of the product?

3. Should the transitional provision in Article 28(2) of Regulation (EC) No 1924/2006 of 20 December 2006 on nutrition and health claims made on foods, as amended by Commission Regulation (EU) No 116/2010 of 9 February 2010, be interpreted to refer to (any) foods which existed prior to 1 January 2005, or to refer to foods to which a trade mark or brand name was affixed and which existed in that form before that date?