ECHA proposes adding 11 substances to REACH Authorization List.

Last week, the European Chemicals Agency (ECHA) announced that it is considering adding 11 substances to the Authorization List, also known as Annex XIV of REACH. The agency is soliciting comments on its draft recommendation, including “comments on the priority of the substances, their uses, possible exemptions from the authorisation requirement and on the proposed transitional arrangements.” In addition, the European Commission is separately accepting comments on the socioeconomic impact of the inclusion of these substances on the Authorization List.

The substances and their common uses, according to ECHA, are:

  • Dihexyl phthalate and 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear (plasticiser in PVC);
  • HHPA and MHHPA (hardener for epoxy resins);
  • Trixylyl phosphate (in lubricants, hydraulic fluids and plastics production);
  • Two boron compounds: sodium perborate; perboric acid, sodium salt and sodium peroxometaborate (in detergents and bleaching products);
  • Four lead compounds: orange lead (lead tetroxide); lead monoxide (lead oxide); tetralead trioxide sulphate and pentalead tetraoxide sulphate (batteries and rubber production, in adsorbents)

Comments will be accepted through February 17, 2016.

Under REACH, substances on the Authorization List are assigned a “sunset date,” after which the substance can only be placed on the market or used if a company has applied for and received an authorization for a specific use. ECHA regularly prioritizes substances from the “Candidate List” and makes recommendations for additions to the Authorization List, including use conditions, application deadlines, and sunset dates. The 11 substances are all proposed to have application deadlines of between 18 and 24 months, with recommended sunset dates 18 months after.

Last week’s recommendations are the agency’s seventh round of recommendations, and include four lead substances that were included in ECHA’s 2014 draft recommendations, but which were not part of the final recommendation submitted to the Commission in July 2015.

After considering public comments, the Member State Committee will prepare an opinion on the agency’s draft recommendation. ECHA will then develop its final recommendation and submit it to the European Commission, which will decide whether to include the substances on the Authorization List and on the conditions applicable for each substance.

FDA seeks input on “natural” food labels.

Last week, the U.S. Food and Drug Administration (FDA) announced that it is seeking comments and information on the use of the term “natural” in food labeling. The move is in response to three citizen petitions, from industry stakeholders, requesting that the agency define “natural” for food labeling and one citizen petition, from Consumers Union, asking for a prohibition on the term. The FDA also stated that it is working with the U.S. Department of Agriculture (USDA) to examine “natural” labeling for meat, poultry, and egg products.

The last time the FDA considered establishing a definition for “natural” in food labeling was 1991, when it published a proposed rule on labeling and sought comment on whether the agency “should establish a meaningful definition for ‘natural’ so that this term would have a common consumer understanding, and whether it should prohibit ‘natural’ claims entirely on the grounds that they are false or misleading.” FDA declined to define “natural” by rulemaking in 1993, but has continued to maintain its policy that labeling a food as “natural” means that “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food.” Critically, the FDA’s policy does not address methods of food production (like genetic engineering or pesticide use) or processing and manufacturing (like pasteurization), nor whether “natural” describes any nutritional or health benefit.

The three petitions to the FDA regarding “natural” labeling all seek guidance on whether “natural” can apply to certain methods of food production, processing, and manufacturing. Two of the petitioners requested better harmonization with the USDA’s Food Safety Inspection Service standards. The Consumers Union petition, seeking a prohibition on “natural” food labeling, argues that “natural” is “vague and misleading,” citing a Consumer Reports National Research Center survey. That survey “suggests that nearly two-thirds of U.S. consumers are currently misled by use of the term ‘natural’ on certain food labels and nearly 90 percent expect it to ‘mean much more than it does.’”

The FDA has posed several specific questions to commenters on when “natural” labeling is misleading to consumers, including input on application to food production, processing, and manufacturing practices, as well as a request for consumer perception data on confusion with terms like “healthy” and “organic.” The agency is accepting comments through February 10, 2016, via docket number FDA-2014-N-1207.