FDA Issues Draft Guidance for MoCRA Facility Registration and Product Listing

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The U.S. Food and Drug Administration (FDA) has released draft guidance, Draft Guidance for Industry: Registration and Listing of Product Facilities and Products, on the new regulatory requirements established in the Modernization of Cosmetics Regulation Act (MoCRA).  Among other provisions, MoCRA added section 607 to the Federal Food, Drug, and Cosmetics Act (FFDCA), requiring cosmetic product facility registration and cosmetic product listing.  The draft document details key registration and product listing requirements, including who must submit, what information is required, when registration and listings must be submitted, and how the FDA intends to accept registration and listing information.

All persons who own or operate a facility engaged in the manufacture or processing of a cosmetic product for distribution in the U.S. must register their facility.  Under MoCRA, a cosmetic product “means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”  FFDCA section 607(a)(1) provides two exceptions regarding who must register.  The first exception is for small businesses that have average gross annual sales of less than $1 million in the previous three years, unless they manufacture or process cosmetics that regularly come in contact with the mucus membrane of the eye, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours (and are not meant to be removed by the customer).  The second exemption is for facilities subject to the drugs and devices requirements under chapter V of the FFDCA, unless they also manufacture cosmetics that are not subject to the drug and device requirements.  The same exemptions apply for submission of product listing information.

Facility registration requirements are outlined in sections 607(a) and (b) of the FFDCA.  The requirements for facility registration include all brand names under which the cosmetic products manufactured or processed in the facility are sold and the product categories for each cosmetic product manufactured or processed in the facility.  Registrations must be submitted by December 29, 2023, for facilities that were manufacturing or processing cosmetic products on December 29, 2022.  Facilities that began manufacturing or processing after December 29, 2022, must register within 60 days of first engaging in that activity or by February 27, 2024, whichever date is later.  Registrations must be updated within 60 days of any changes to the registration information and must be renewed biennially.

Product listing requirements are outlined in FFDCA section 607(c) and include the facility registration number for each facility where the cosmetic product is manufactured or processed, its applicable cosmetic category or categories, and a list of product ingredients (including fragrances, flavors, or colors).  Listings must be submitted by December 29, 2023, for products that were marketed on December 29, 2022.  Products that were first marketed after December 29, 2022, must be listed within 120 days of marketing the product, or within 120 days of December 29, 2023, whichever date is later.  Any updates to the listing must be made annually.

Importantly, FDA clarified that any prior registrations through the Agency’s voluntary cosmetics registration programs will not be transferred to the new system; submitters will have to re-submit this information.

According to FDA, an electronic submission portal should be open for submissions beginning in October 2023, although a paper submission form is also available.

EU, U.S. TTIP negotiators discuss reducing chemical costs, regulating cosmetics.

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Last week, U.S. and European Union (EU) negotiators held a second round of Transatlantic Trade and Investment Partnership (TTIP) discussions. During the week-long talks, negotiators examined how to reduce regulatory and industry costs for chemicals.

According to U.S. TTIP chief negotiator Dan Mullaney, a range of tools are available to reduce costs for chemicals and other sectors.  Ignacio Garcia Bercero, the EU’s chief negotiator, said specific ideas for cost reduction include harmonization of labeling requirements and better cooperation between the EPA and ECHA in performing risk assessment and exchanging data to avoid unnecessary testing. Bercero said the European and U.S. negotiating teams also discussed regulatory compatibility for cosmetics. Negotiators considered the feasibility of achieving “greater convergence” between the positive and negative lists of cosmetic ingredients in the EU and the U.S., which may be difficult since the U.S. allows certain cosmetic ingredients that are prohibited in the EU, said Bercero.

Meanwhile, NGOs have continued to express concerns over the lack of transparency in TTIP negotiations. Spokespeople from the European Consumer Organization (BEUC) and Friends of the Earth Europe said that open negotiations are necessary to ensure that the trade deal does not undermine or eliminate existing consumer legislation in the EU, as well as U.S. states like California with stricter chemical legislation. Both groups want access to the negotiating texts and regular consultations before and after each negotiating round. In response to NGO concerns, both Mullaney and Bercero said that talks on regulatory convergence in the chemical sector will not affect the level of protection or legislation under REACH or TSCA. The EPA has also stated that it does not believe TTIP negotiations will influence the agency’s “risk-based approach to chemicals management.”

The next round of TTIP negotiations will take place in Washington, D.C., between December 16 and 20.

New EU Cosmetics Regulation To Take Effect in July 2013.

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On July 11, 2013, the new European Union (EU) cosmetics Regulation (EC 1223/2009) will fully replace the existing cosmetics Directive (76/768/EEC) that has applied since July 27, 1976.  Unlike the previous EU cosmetics Directive, the self-executing Regulation unifies the cosmetics requirements of the European Economic Area (EEA) into a single law and eliminates ambiguities that may occur among EU member states during the enforcement process. The new Regulation, which applies to all EU cosmetics companies, is intended to ensure that consumers’ health is protected and that they are well informed by monitoring the composition and labeling of cosmetic products.

The Regulation is focused on simplifying procedures, streamlining terminology, and strengthening certain elements of the regulatory framework for cosmetics. The main changes it introduces include:

  • creating a new, electronic, centralized system that will replace the current national competent authority notification process
  • clarifying the format and content of the product information file (PIF) to be used in conducting a product safety assessment; particularly, the PIF must include data to support any claims made about a product
  • narrowing the “exceptional cases” when substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMRs) can be used
  • requiring the presence of nanomaterials in cosmetic ingredients be clearly indicated by the word “nano” in brackets
  • requiring cosmetics companies to designate a legal or natural person within the EU—known as a “responsible person”—whose role will be to ensure certain safety requirements for each cosmetics product introduced on the market

The Regulation also continues the previously established ban on animal testing, which came into full force through the Cosmetics Directive on March 11, 2013. Although the inclusion of the ban has been applauded by many consumers and animal welfare groups, it has also raised some concerns in the cosmetics industry about the potential negative impact on innovation due to the inability to fully test new ingredients as well as potential conflicts arising from the testing requirements imposed by other regulations. The European Commission has posted an impact assessment [PDF] online that discusses the various effects of the ban.

Notable milestone reached by the Regulation en route to becoming applicable, exclusively, to cosmetics placed on the EU market include: prohibiting use of CMR 1A/1B/2 substances in cosmetics, although certain CMR 2 substances may be exempted by the EU Scientific Committee of Consumer Safety (SCCS) after assessment; submission of all cosmetics through the new centralized notification system; commencing the  notification process  for nanomaterials already on the market.  All cosmetics are expected to be fully compliant with the new Regulation by July 11, 2013.