Weekly Compliance Digest – REACH Data-Sharing, FDA Food Contact Substances

January 15, 2016 By
In this edition of the Weekly Compliance Digest, we cover a new regulation clarifying data-sharing principles under the EU’s REACH regulation on chemicals, and a final rule from the U.S. FDA that amends food additive regulations.

Regulation (EU) 2016/9 on joint submission of data and data-sharing

What is it?

The European Commission published an Implementing Regulation on January 6, 2016 that defines more clearly what the terms “fair, transparent and non-discriminatory” mean for data-sharing within the EU REACH Regulation on chemicals. Under REACH, companies that have registration obligations for substances are required to share information about the substances being manufactured, imported, placed on the market and used in the EU. The objectives of this requirement are to: 1) Reduce costs for registrants of the same substance, and 2) avoid unnecessary testing on vertebrate animals. For example, if information is available, REACH requires studies involving vertebrate animal testing to be shared between registrants in order to prevent duplicate tests. The main mechanism for data-sharing is the Substance Information Exchange Forum (SIEF) that brings together multiple registrants of the same substance.

Who is affected?

The regulation applies to companies that meet all of the following three conditions:

  • The company is either:
    • A chemical or article manufacturer or distributor based in the EU.
    • An EU company that imports chemicals or articles into the EU.
    • A chemical or article manufacturer from anywhere in the world that exports products into the EU.
  • The company has REACH registration obligations for a substance found in chemical products or articles.
  • The company is a member of a SIEF because it is part of a joint registration of a substance with other companies.

What are the requirements?

The regulation aims to make data-sharing agreements in SIEFs clear and comprehensive. It includes the following provisions mentioned in a press release from ECHA:

  • Potential registrants joining a SIEF are given the right to request a breakdown of the study and administrative costs that make up the price for the joint registration.
  • Registrants are only required to share the costs of information they need to submit to the Agency. For example, they don’t need to pay for data that goes beyond the requirements for their tonnage band.
  • Registrants are required to estimate the total number of potential registrants for a substance and future additional information requirements, and take these into account when agreeing on the cost-sharing model.
  • Registrants are required to set up a reimbursement mechanism as part of the cost-sharing model. This mechanism should consider potential future registrants and registration requirements, and include a method of reimbursement to each co-registrant once a new registrant joins the agreement.

What is next?

The Implementing Regulation was published in the Official Journal of the European Union on January 6, 2016. It enters into force on January 26, 2016.

ECHA will be given a stronger role in getting companies to submit a joint registration when there are multiple registrants for the same substance. The new REACH-IT, to be launched in late spring 2016, will not allow registrations outside of joint submissions. In addition, ECHA will update its IT tools, related guidance documents and other support material to reflect the changes.

FDA Indirect Food Additives: Paper and Paperboard Components

What is it?

On January 4, 2016, the FDA published a final rule amending the food additive regulations to no longer provide for the use of three specific perfluoroalkyl ethyl containing food-contact substances (FCSs) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods. The FDA says new data is available regarding the toxicity of substances structurally similar to these compounds that demonstrate there is no longer a reasonable certainty of no harm from the food-contact use of these FCSs. The rule was published in response to a petition filed by the Natural Resources Defense Council, the Center for Food Safety, the Breast Cancer Fund, the Center for Environmental Health, Clean Water Action, the Center for Science in the Public Interest, Children’s Environmental Health Network, Environmental Working Group, and Improving Kids’ Environment.

Who is affected?

Companies in the Food and Beverage industry and the Food Service industry, as well as companies that manufacture food packaging items and materials to the aforementioned companies.

What are the requirements?

The final rule prohibits the use of the following three chemicals in food containers and packaging that are resistant to oil and water, such as pizza boxes and microwave popcorn bags:

  • Diethanolamine salts of mono- and bis (1 H, 1 H, 2 H, 2 H perfluoroalkyl) phosphates where the alkyl group is even-numbered in the range C8-C18 and the salts have a fluorine content of 52.4% to 54.4% as determined on a solids basis.
  • Pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20-alkyl)thio] derivatives, compounds with diethanolamine (CAS Reg. No. 71608-61-2).
  • Perfluoroalkyl substituted phosphate ester acids, ammonium salts formed by the reaction of 2,2-bis[([gamma], [omega]-perfluoro C4-20 alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and ammonium hydroxide.

What is next?

The final rule was published in the Federal Register on January 4, 2016, and became effective as of that date. Electronic or written objections, and requests for a hearing can be submitted by February 3, 2016.

Visit Enablon Insights again next Friday for a brand new Weekly Compliance Digest!

Categories: EHS

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