Biocidal Products Regulation Enters Into Force in EU.

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The Biocidal Products Regulation (BPR; Regulation (EU) 528/2012), which repeals and replaces the Biocidal Products Directive (BPD, 98/8/EC), entered into force on September 1, 2013. The BPR retains the legal framework established by the BPD, including the two-tier approval system for biocidal substances, but also introduces a number of new provisions, such as those relating to treated articles and food contact materials containing biocides.

In order to prepare applicants for the new changes, ECHA recently published priority guidance on applying information requirements for biocidal active substances (Annex II) and biocidal products (Annex III). The head of ECHA’s biocides unit, Hugues Kenigswald, says that there are a number of further documents in development that will complement it. However, applicants can begin submitting biocidal and technical equivalence dossiers immediately.

Unless they are included in ECHA’s list of approved active substance suppliers, all manufacturers or importers of active substances contained in biocidal products must submit a dossier before placing products on the market. Applicants can prepare a dossier by using the first versions of BPR submission tools, the Iuclid report generator software and the R4BP3 register for biocidal products. The ECHA has published guidance for using these tools on their website.

Some in the industry worry that the submission process, particularly the Iuclid software, will be too complex for companies. Yet overall, industry is expected to benefit from the Regulation, which will allow industry to request an EU-wide authorization for biocidal products, thereby removing national barriers to trade. This simplified and more efficient product authorization, along with data sharing and information requirements, is estimated to save industry € 2.7 billion over a period of 10 years. However, Mr. Kenigswald did express concern as to whether member states will have enough resources to provide the support needed to make the BPR an effective Regulation.

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.