#EURegulation Archivi | Carmen Sorice Regulatory Affairs Guidati dalla Conoscenza, Sostenuti dalla Qualità, Impegnati nella Sicurezza. Tue, 13 Oct 2026 08:25:21 +0000 en-US hourly 1 https://wordpress.org/?v=7.1.4 https://carmensorice.com/wp-content/uploads/2023/10/cropped-Carmen-Sorice-Regolatory-Affarirs-32x32.png #EURegulation Archivi | Carmen Sorice Regulatory Affairs 32 32 New EFSA assessment on styrene https://carmensorice.com/en/blog-en/new-efsa-assessment-on-styrene/ Sat, 18 Jan 2025 06:54:01 +0000 https://carmensorice.com/news-carmen-en/new-efsa-assessment-on-styrene/ L'articolo New EFSA assessment on styrene proviene da Carmen Sorice Regulatory Affairs.

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The European Food Safety Authority (EFSA) Panel on food contact materials (FCM) has issued a draft opinion stating that there is no scientific evidence to demonstrate the genotoxicity of styrene following oral exposure and that the use of styrene in the production of FCM with a specific migration limit (SML) of 40 µg/kg of food does not pose a health risk.

EFSA has recently carried out a new assessment of the public health risks of styrene, a substance used in plastic FCM, currently regulated in Regulation (EU) 10/2011 on plastics without a specific migration limit (SML) or other use restrictions.
In 2019, the International Agency for Research on Cancer (IARC) published a monograph classifying styrene and its main metabolite, styrene-7,8-oxide (SO), as “probably carcinogenic to humans”. As this classification could influence the inclusion of styrene in the Plastics Regulation, the European Commission asked EFSA to assess whether the evidence presented by IARC could impact the safety of using styrene in food contact materials.

In September 2020 EFSA, with a first assessment, concluded that concerns about the genotoxicity of styrene following oral exposure could not be excluded and that further data were needed to accurately assess its safety in FCM.
Considering the uncertainty about genotoxicity, the absence of an SML and the high potential for styrene to migrate into food from FCM, the European Commission proposed a draft measure setting an SML for styrene of 40 ppb, based on the tolerable daily intake (TDI) suggested by the World Health Organization (WHO) for styrene in drinking water.
The European Commission subsequently requested EFSA to review the potential genotoxicity of styrene following oral exposure and its safety for use in plastic FCM with an SML of 40 ppb.
As the WHO TDI predates the new scientific information emerging from the 2019 IARC classification and EFSA opinion in 2020, EFSA conducted a new assessment to determine whether the 40 ppb limit for styrene in food was adequate to ensure safety, evaluating, among others, the studies reported in the 2019 IARC monograph.

EFSA concluded that the reviewed studies did not show evidence of genotoxic effects of styrene following physiological exposures, including oral exposure.
For substances for which no genotoxic effects have been found, EFSA’s Note for Guidance for FCM states that an SML of up to 50 µg/kg food would not pose a health risk. Therefore, the use of styrene in the production of FCM with a migration limit set at 40 µg/kg food does not pose a health risk to consumers.

EFSA invited interested parties to submit comments on the draft opinion by 28 January 2025.

L'articolo New EFSA assessment on styrene proviene da Carmen Sorice Regulatory Affairs.

]]> EU opens consultation on the draft of 18th amendment to Regulation 10/2011 on plastic materials https://carmensorice.com/en/news-en/eu-opens-consultation-on-the-draft-of-the-18th-amendment-to-regulation-10-2011-on-plastic-materials/ Fri, 15 Mar 2024 14:28:39 +0000 https://carmensorice.com/?p=2444 L'articolo EU opens consultation on the draft of 18th amendment to Regulation 10/2011 on plastic materials proviene da Carmen Sorice Regulatory Affairs.

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On March 13, 2024 the European Commission opened the public consultation on the draft of a new regulation which will update Regulation (EU) no. 10/2011 on plastic materials intended for contact with food.
This legislative measure was necessary in particular to align with Regulation (EU) 2022/1616 on recycled plastics and Regulation (EU) No. 528/2012 on biocidal products

Main updates of the new regulation

The main changes brought by the new regulation will concern:

  • Clarifications regarding the purity requirements of authorized substances and rules for the use of authorized natural materials.
  • Indications on the reprocessing of plastic materials (processing waste and scraps).
  • Integration into Regulation (EC) no. 2023/2006 on good manufacturing practices for MOCA, rules on quality control and management of waste and processing scraps.
  • Elimination of article 7 (provisional list) and revision of the exemptions for substances not included in the Union list for biocidal products already authorized in Regulation (EU) 528/2012 for food contact (PT4), for use as additives for plastic materials.
  • Review of migration testing rules for multi-material multilayer fcm: application of migration limits when the plastic material is the layer in contact with food.
  • Review of tests and labelling for articles intended for repeated use.
  • Review of the declaration of compliance with the addition of new points for indications on recycled plastics and the possible reprocessing of plastic material.
Clear plastic containers with pulses and pasta

Transitional Provisions

The new update provides for an 18-month transition period to facilitate the adaptation of the industries involved.

Consultation and Publication

The Commission opened the public consultation from 13 March to 10 April 2024, inviting all interested parties to actively participate in the definition of this new legislative measure.
The adoption of the new Regulation is scheduled for the second quarter of 2024.

Coloured plastic containers filled with food

L'articolo EU opens consultation on the draft of 18th amendment to Regulation 10/2011 on plastic materials proviene da Carmen Sorice Regulatory Affairs.

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