The U.S. government should work to eliminate differences in supplement claims regulations with the European Union, a trade group says.

The Council for Responsible Nutrition, in June 2 comments to the International Trade Administration, says it “does not expect, nor necessarily desire” harmonization of regulations, but that the government should “reduce or eliminate non-tariff barriers to trade in these products,” particularly in health claims regulations.

EFSA Claims Approval And WTO

EFSA regulations are “more trade restrictive than necessary” to accomplish goals, CRN says.
Another WTO member can bring a challenge only once the European Commission formally adopts the rules.
Failure to adopt EU-wide nutrient maximums also hurts U.S. supplement makers, CRN says.
Smaller firms are hurt more by the high cost and long delays of country-by-country claim approvals.

The European Food Safety Authority “has routinely denied the existence of a causal relationship” between a food or ingredient and a health effect “unless demonstrated in randomized, controlled clinical trials,” CRN VP for Scientific and International Affairs John Hathcock says in the comments submitted to ITA, an arm of the Department of Commerce.

EFSA proposed a number of regulations governing health claims for dietary supplements, known as food supplements in the EU. If the European Commission, the EU’s executive branch, adopts those regulations, it will create a trade barrier in violation of World Trade Organization regulations, Hathcock said in an interview.

He emphasized there is no violation unless the European Commission adopts the regulations. CRN included in its submission an April 25 memorandum prepared by law firm Sidley Austin that emphasizes that the regulations as written do not violate WTO rules, but as applied would be inconsistent with the Technical Barriers To Trade agreement.

Regulations Require Pre-Approval

The EU rules prohibit several classes of health claims and mandate an affirmative statement on food, aspects of the regulation with which CRN does not take issue, according to the Sidley Austin memo.

However, EFSA requires the claims be substantiated by “generally accepted scientific evidence” and that the health claims be in a list of authorized claims to remain or be introduced to the EU market.

Although regulations say EFSA should consider the totality of evidence, the agency is not, Hathcock maintains.

In a briefing document for stakeholders, EFSA said it would consider a claim to be substantiated only if it met three criteria, including if “a cause and effect relationship is established between the consumption of the food/constituent and the claimed effects,” the Sidley Austin memo says.

“Impossible Standard”

Additionally, the agency expects data of the quality that would be published in a peer-reviewed journal (Also see "EFSA Guidance Seeks High-Quality Data In Health Claim Applications" - Pink Sheet, 27 August, 2007.).

“Our beef with that, so to speak, is that evidence-based nutrition is inherently different from evidence-based medicine in that there is no such thing as a true control group for nutrition,” Hathcock added.

There are no true placebo groups when studying nutritionals, Hathcock said, noting it is unethical to deprive test subjects of a necessary nutrient and that many people already have most nutrients in their systems.

Even if a firm had an unlimited budget or found a way to work around the ethical issues, “it simply is not technically feasible” to study nutrient consumption over several decades, he added.

“It’s just not doable,” he said. “They seem to be setting up an impossible standard.”

EFSA has rejected 95% of proposed claims, the report says. The agency has released decisions in waves, with the final batch of approval results expected shortly (Also see "News In Brief" - Pink Sheet, 18 April, 2011., In Brief).

“More Trade-Restrictive Than Necessary”

The Technical Barriers To Trade Agreement Article 2.2 is the WTO agreement at issue, the Sidley Austin attorneys write. It provides that WTO members shall ensure that technical regulations do not create unnecessary obstacles to international trade and “shall not be more trade-restrictive than necessary to fulfill a legitimate objective.”

EFSA claims regulation results in an unnecessary obstacle to international trade because it is more trade restrictive than necessary to fulfill its objectives of increasing legal security for economic operators, ensuring fair competition and promoting and protecting innovation, the memo says. The EU could “satisfy the same objectives with alternative, less trade-restrictive measures,” like permitting the use of claims for which there is support, even when that support is “not unequivocal,” the attorneys say.

The obstacles to trade are high, the memo notes. The regulations impact up to $379 million (€260 million at June 8 exchange rates) of trade and lead to decreases in revenue of 25% or more, according to the report. Packaging changes would add $424 million (€291 million) in costs.

If a WTO member believes another member is violating the agreement, it may initiate dispute settlement proceedings, the memo says. If a panel found the claims regulation violates the agreement, “then the EU would be required to withdraw or modify the measure, or face the possibility of authorized trade retaliation” by the member that initiated the complaint, the memo adds.

Claims, Country By Country

Nordic Naturals, a U.S. company that sells its omega-3 supplements in several European companies, seeks approval for its claims country by country rather than going through the EFSA process.

“As much as Europe seems to be unified, it is certainly not unified as far as supplements are concerned,” International Sales Manager Jean-Philippe Sidaner said in an e-mail.

Laws and regulations differ by country, as do cultural differences that could impact labeling, he added.

Although there is no cost for product registration in the U.S. – unless the firm seeks legal assistance in dealing with federal agencies – laws and regulations “tend to be tighter and more expensive” in foreign markets, Sidaner said.

“It is at this point not detrimental to Nordic Naturals but could definitely deter smaller companies,” he added.

Costs are similarly high as firms attempt to navigate the EFSA approval, stakeholders said early last year (Also see "EFSA Guidance Seeks High-Quality Data In Health Claim Applications" - Pink Sheet, 27 August, 2007.).

Stakeholders have noted particularly the impact on smaller firms (Also see "EU Natural Health Product Laws Sprout Obstacles For Smaller Companies" - Pink Sheet, 10 November, 2008.).

Nutrient Limits Also At Issue

Additionally, CRN expressed concerns in its comments to ITA that an EU-wide rule on the maximum levels of vitamins and minerals allowed in products has not yet been released.

“There is some kind of political hang-up in the process.” – CRN’s Hathcock on EU-wide adoption of nutrient maximums

The failure to act has allowed each country to enact its own regulations, and, because countries use RDA levels rather than risk assessment, many high-potency U.S. products are kept out of European markets, Hathcock said.

The comment period on the regulations closed and comments were posted on the commission’s website in 2006. CRN is aware the regulations have been in “private draft form within the commission staff” for the last several years, he added.

“There is some kind of political hang-up in the process,” Hathcock said.

Codex Alimentarius guidelines adopted in 2005 demand the maximums be based on risk assessment, he said. Failing to recognize Codex regulations as the standard for international food regulation is a violation of WTO and EU agreements, he notes in the written comments.

By Carolyn B. Phenicie

EU Claims Approval Process Violates World Trade Organization Rules – CRN

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