The Institute for Agriculture and Trade Policy (IATP) Europe appreciates this opportunity to comment on the Draft. IATP, a U.S. headquartered non-profit, non-governmental organization founded in 1986, opened the IATP Europe office in Berlin in 2017. IATP has participated in the Transatlantic Consumer Dialogue (TACD) since 2000 and, since 2016, has been the U.S. co-chair of the TACD Food Policy Committee. TACD presented resolutions on transatlantic cooperation in chemicals regulation, including nanomaterials, to the European Commission in 2013 and 2016. IATP is one of seven NGOs and a labor union that in 2015 released a “Policy for Nanomaterials in Food and Food Packaging” addressed to companies employing nanomaterials. In 2012, IATP submitted comments to the draft Food and Drug Administration Guidance for Industry on “significant new manufacturing changes,” including those of nanotechnology, applied to food and food additives.
Overview: Comment on the Guidance Summary
The legal status of this draft Guidance is contradictory. Here (lines 148-150) compliance with the Guidance is a "must." Elsewhere (e.g. 356-358) compliance is voluntary, i.e. "should," as with the U.S. Food and Drug Administration (FDA) Guidance on nanomaterials in food and feed, e.g: “FDA continues to welcome consultations with industry as an approach to ensuring that food developed using new technologies will be safe,” (at 15). NGO testing of food products with nanomaterials, (e.g. nano-hydroxyapatite in infant formula). and nano titanium dioxide in candy and pastry glazes, suggests that voluntary consultations with FDA have been absent or inadequate to secure industry cooperation. IATP urges EFSA not to emulate FDA's voluntary approach. Applicants to commercialize food and feed products with nanomaterials must demonstrate their compliance with the EFSA Guidance. The EFSA Management Board must make clear in a cover note to the Guidance that mandatory compliance with the Guidance is authorized by the 2018 revision to the Novel Food Regulation. Even though the 2018 revision enables "generic authorizations," rather than applicant specific ones, manufacturers of nanotechnology-enabled food and feed still must comply with the Guidance to comply with the pre-market safety assessments required by the Novel Food law.
The study EFSA commissioned in 2014 shows that 55 nanomaterials were incorporated into foods, food supplements or food packaging already commercialized or intended to be commercialized in the Member States (lines 388-392). In May 2017, EFSA, other Commission agencies and Member States officials were beginning to discuss standardization of nanomaterial measurements and the reliability of those measurement results. It appears that European food manufacturers commercialized novel foods with nanomaterials in advance of the 2018 revision of the Novel Foods Regulation, which appears to retroactively legalize that commerce. Nevertheless, EFSA must have the scientific capacity and legal authority to document publicly that "the scientific appropriateness of the [analytic] methods used are substantiated by the applicants" (lines 405-406). Absent that capacity and transparency of pre-market safety assessment, the legal concept of "generic authorizations" in the 2018 revision of the Novel Food Regulation will be read by consumer and environmental organizations as a regulatory loophole designed to expedite commerce, not to protect consumers or the environment. In the absence of the regulation of food and agri-nanotechnology, consumer organizations have had to use their scarce resources to detect nanomaterials in unlabeled food and cosmetic products.
Nanoscience is the basis for a broad technological platform whose applications have many benefits. If EFSA, Member States and the food/feed industry do not wish nanotechnology to become the "new GMO," they must cooperate to transparently document applicant compliance with the Guidance. They must not replicate with nanotechnology the unhappy U.S. history of voluntary industry consultations and heavily-redacted commercialization applications for GMOs.
The full letter can be read in the PDF below.