Draft guidance spells out article 13.4 health claim potential

The article has been highlighted as a means for rejected article 13.1 generic health claims to be bolstered, refined and resubmitted, and the draft document details how such submissions should proceed.

The draft guidance – produced by a member state – points out that applications should be made by “food operators”,​ which are than entered into the health claim process by member states.

It highlights that the article – written into the regulation to account for any amendments that may occur to any list of published article 13.1 claims – is relevant only to article 13.1 claims, and not disease and children’s development claims.

It clarifies also that emerging and proprietary science claims under article 13.5 may not be resubmitted in article 13.5.

Only claims that do not, “rely on newly developed scientific evidence” ​can be resubmitted.

But the draft guidance states article 13.4 is relevant for: “An application which aims at modifying a generic claim currently being assessed by EFSA…” ​as well as: “An application concerning a claim negatively evaluated by EFSA in the context of Article 13(3) [adoption of Community list], but which may benefit from the further assessment procedure proposed by the European Commission.”​

The draft document then details how an application should proceed under article 13.4, including reasons for initial EFSA rejection; description of new data to be submitted; the status of the claim in other European and international jurisdictions along with typical dossier requirements such as characterization of substances and measurement of beneficial effects.

Recently,​Patrick Coppens, the secretary general of Belgian trade group, the European Responsible Nutrition Alliance (ERNA), said he expected that there was a lot data that had not been submitted due to the vagaries of the article 13.1 process, and which could be added to adjusted claims now that certain aspects of the regulation’s requirements had become clearer.

The full text of the 2006 nutrition and health claims regulation can be found here​ .