ECJ strikes down German amino acid restrictions
The ECJ’s ruling will mean a major shift in how Germany sets rules for ingredients such as amino acids, but stops short of making the EU the final authority on such rules.
German law on foodstuffs and animal feed – the Lebensmittel- und Futtermittelgesetzbuch (LFGB) – currently offers only temporary derogations of up to three years on the use of amino acids, which can only be renewed three times.
In 2006 Queisser Pharma applied for a derogation for the use of L-histidine in a supplement, claiming at the same time there was no need for a licence, as L-histidine could not be harmful to human health.
The German authorities denied this application in 2012, and following a number of appeals the case reached the ECJ. Queisser based its case on the claim that Germany’s code was overly strict.
EU law trumps national law
The Court agreed with this, ruling: “[Articles 6 and 7 of Regulation (EC) No 178/2002] must be interpreted as precluding such national legislation, where that legislation lays down that the derogations to the prohibition covered by it may only be granted for a specific period even in cases where the safety of a substance is established.”
Katia Merten-Lentz, partner at law firm Keller and Heckman, said the case would now go back to the German court: “The national debate will be reopened, meaning both parties will have the opportunity to comment on the European ruling.
“The European Court of Justice’s ruling is not the end of the discussion – the court has just given some clues, a decision tree, to the national court to find a solution,” she added, saying she would expect the German court to rule on the case within the next six months.
On the implications for Germany, Luca Bucchini, MD at Hylobates Consulting, said: “They will have to modify their legislation to bring it in line with EU law: no temporary derogations, but permanent risk based rules for amino acids in food supplements and food.
“The German court will have to check that German authorities have not identified risks for human health for most amino acids, as the ECJ suspects. Regardless, Germany has to change at least the temporary nature of derogations,” he added.
Merten-Lentz agreed, saying the German law did not abide by the EU’s precautionary principle: “If a food supplement is really dangerous, it should be forbidden immediately. But if a food supplement is not dangerous, why is it forbidden but with an exception? It doesn’t make sense on a regulatory basis – if it’s dangerous it should be forbidden, if it’s not dangerous, it should be fully authorised.”
Bucchini said it is likely Germany will carry out a risk assessment of amino acids and then set permanent regulations – but suggested this could take some time, as the German legislative process is “not swift”.
No EU rules, but harder to restrict ingredients
“Where the judgment is perhaps disappointing from an industry's perspective is that it does not imply that rules on amino acids shall be established at EU level, based on an assessment by EFSA,” he said.
“That would have been great progress, and may still happen if Germany decides that it is the simpler solution to their legislative problem. Instead the Court found that EU law does not lead automatically to that conclusion,” Bucchini added, noting there was a risk of member states creating different sets of rules on amino acids.
But he said the Court’s ruling meant Germany and other member states would now need to use risk-assessments and fact-based decision-making when restricting the use of ingredients.
“Since many member mtates have the habit to prohibit or limit substances with no scientific basis, the ruling makes their life a bit less easy: there is no excuse, even for local products, to have severe restrictions with no factual evidence,” said Bucchini.
Queisser Pharma itself already succeeded in securing a derogation to use L-histidine, after the German authorities reversed their decision in 2015.
