Loophole free: EU’s highest court backs health claim regulation in disease ruling


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Owen Warnock, lawyer: “The label need not expressly assert that the reduction in the risk factor is ‘significant’.”
Owen Warnock, lawyer: “The label need not expressly assert that the reduction in the risk factor is ‘significant’.”
The Court of Justice of the European Union (ECJ) has backed key principles of the EU health claims regulation – and closed potential loopholes, according to a leading UK lawyer.

“This is a perfectly sensible and predictable decision by the ECJ, although it does contain one aspect which I fear may lead to future confusion,”​ said Owen Warnock, partner in the London office of Eversheds.

The ruling found Czech pharma-supplements firm, Green–Swan Pharmaceuticals, was indeed making un-backed, osteoporosis disease risk factor reduction claims for a trademarked calcium-vitamin D3 product.

In coming to that conclusion it affirmed that a disease risk factor reduction claim under the EU 2006 nutrition and health claims regulation (NHCR) could be implied and did not have to contain words like ‘significant reduction’ to fall under the remit of that law.

“The ECJ has confirmed that a claim will be categorised as a ‘reduction of disease risk claim’ if the consumer ​understands it to suggest a significant reduction in a risk factor for disease,”​ Warnock reasoned.

“The label need not expressly assert that the reduction in the risk factor is ‘significant’.”

Claim sub-category

However Warnock added there remained some room for interpretation in the ruling.

The concern is that this judgement might be understood by some to suggest that if careful wording were used then it could be argued that the claim of reduction in disease risk was not of a ‘significant’ reduction so that the claim would not be a ‘reduction of disease risk claim’.” 

“However, that would not be enough to get a claim outside the regulation, since it would still probably be a ‘health claim’ – just not a the special type which has its own particular approval mechanism under Article 14 of NHCR.”

“The Court itself pointed out that a disease risk reduction claim is only a sub-category of health claim.”

Green–Swan Pharmaceuticals was making the claim, "calcium and vitamin D3 help to reduce a risk factor in the development of osteoporosis and fractures".

The Court also confirmed the use of certain trademarks until 2022, if they existed before 2005 as is written in the NHCR.

No escape route

That was an affirmation that Italy-based legal expert Luca Bucchini said may provoke revision among certain EU member states, even though the ECJ ruling says it is member states who must first determine what is a valid trademark.

“Some national authorities have disregarded the transition period for trademarks: They may need to think again,”​ Bucchini said.

He added: “The court clarified the obvious – that not all food products with claims and without transition trademarks can make claims. There is no secret escape route from the NHCR.”

“Overall, the Court shows its readiness to back the regulation, and the Commission's reading of it. Those who expect the Court to change the game significantly in the near future may be disappointed.”

The ECJ ruling can be found here​.

Green–Swan Pharmaceuticals was not available for comment at the time of publication.

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