Chemical Regulatory Updates – Latest Global Changes

Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers; Final Rule; Response to Objection; Confirmation of Effective Date

Distribution date: 14 November 2024

The Food and Drug Administration (FDA or we) is responding to the objection that we received from the Environmental Defense Fund, Breast Cancer Prevention Partners, Environmental Protection Network, Environmental Working Group, and Healthy Babies Bright Futures on the final rule that amended the food additive regulations to no longer provide for the use of 25 plasticizers that the petition identified as ortho-phthalates because these food additive uses have been permanently abandoned. After reviewing the objection, FDA has concluded that the objection does not provide a basis for modifying FDA’s final rule amending the food additive regulations.DATES: The effective date of 20 May 2022, for the final rule published on 20 May 2022 (87 FR 31080), is confirmed.

Products Covered: Polycarboxylic acids, their anhydrides, halides, peroxides and peroxyacids; their halogenated, sulphonated, nitrated or nitrosated derivatives (HS code(s): 2917); Food technology (ICS code(s): 67)

Regulation Type: Addendum to Regular Notification

Food additives Food safety Human health Adoption/publication/entry into force of reg.

Environmental Defense Fund, et al.; Response to Objections and Requests for a Public Hearing; Notification; Response to Objections and Denial of Public Hearing Requests

Distribution date: 14 November 2024

The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by the Environmental Defense Fund, Learning Disabilities Association of America, Center for Food Safety, Center for Environmental Health, Center for Science in the Public Interest, Breast Cancer Prevention Partners, Defend our Health, and Alaska Community Action on Toxics on the denial of a food additive petition (FAP 6B4815) requesting that we revoke specified regulations to no longer provide for the food contact use of 28 ortho-phthalates. We are overruling the objections and denying the requests for a public hearing.

Products Covered: ICS Code(s): 67. Food contact substances

Regulation Type: Addendum to Regular Notification

Packaging Food safety Human health Adoption/publication/entry into force of reg. Contaminants

Application for reassessment an approval – APP204694 application to reassess chlorpyrifos. Staff Assessment Report: Application to reassess chlorpyrifos and chlorpyrifos containing substances.

Distribution date: 13 November 2024 | Final date for Comment: 12 February 2025

The EPA is proposing to revoke the approvals for all chlorpyrifos containing substances.The approvals under the Hazardous Substances and New Organisms Act 1996 for the import and manufacture for release for chlorpyrifos and chlorpyrifos containing substances are proposed to be revoked. It is proposed that there are non-negligible risks to the environment and to human health. These risks cannot be sufficiently mitigated through restrictions, to a point where the benefits would outweigh these risks. The EPA therefore proposes that the approvals should be revoked with a 6 month phase out period from the date of decision. Additional restrictions on the use of chlorpyrifos containing substances are proposed over the period of the restriction. The assessment of risks, benefits and the proposed revocation of the approvals are detailed in the application and staff assessment report. Similar regulatory action has been undertaken by other regulators internationally, with chlorpyrifos not permitted for use in Canada and the European Union, and significant restriction in Australia. We also note that chlorpyrifos is proposed to be listed for elimination under the Stockholm Convention.

Products Covered: Pesticides containing the active ingredient chlorpyrifos