Archives

April 26, 2024

EC Communication Defines Principles on Limiting Most Harmful Chemicals to Essential Uses

On April 22, 2024, the European Commission (EC) announced that it adopted a “Communication from the Commission: Guiding criteria and principles for the essential use concept in EU legislation dealing with chemicals.” The press release states that “[t]he overall aim of this concept is to achieve higher regulatory efficiency and predictability for authorities, investors and industry for a faster phase-out of the most harmful substances in non-essential uses, while allowing more time for the...
March 28, 2024

EC Publishes Communication on Biotechnology and Biomanufacturing, Announces Targeted Actions

The European Commission (EC) announced on March 20, 2024, that it has proposed a series of targeted actions to boost biotechnology and biomanufacturing in the European Union (EU). The EC states that its March 20, 2024, Communication on Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU “identifies the challenges and barriers and proposes to tackle them, in line with the Communication on the long-term competitiveness of the EU.” According to the...
April 27, 2023

Council of the EU Approves Conclusions on the Opportunities of the Bioeconomy

By Lynn L. Bergeson and Carla N. Hutton   On April 25, 2023, the Council of the European Union (EU) announced that it approved the conclusions on the opportunities of the bioeconomy in light of current challenges, with special emphasis on rural areas. Using biomass to produce food, materials, and energy can help boost rural communities, increase competitiveness, and combat many of the challenges facing the EU. According to the press release, in their conclusions,...
February 27, 2023

EC Appeals European General Court Decision Annulling the Harmonized Classification and Labeling of Titanium Dioxide

On February 14, 2023, the European Commission (EC) appealed the November 23, 2022, decision of the European General Court that annuls the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. As reported in our December 6, 2022, memorandum, the court concluded that the EC “made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based and,...
July 18, 2022

EC Requests Scientific Opinion on Titanium Dioxide in Cosmetic Products

The Scientific Committee on Consumer Safety (SCCS) announced on June 22, 2022, that the European Commission (EC) asked that it reassess the safety of titanium dioxide with a focus on genotoxicity and exposure via the inhalation and oral route (lip care, lipstick, toothpaste, loose powder, hair spray) “since the currently available scientific evidence supports an overall lack of dermal absorption” of titanium dioxide particles. The request notes that titanium dioxide is authorized...
June 10, 2022

EC Revises Definition of Nanomaterials

On June 10, 2022, the European Commission (EC) announced that it is clarifying the definition of nanomaterials in a new Recommendation that supports a coherent European Union (EU) regulatory framework for nanomaterials, helping to align legislation across all sectors. The EC states that the new definition should be used in EU and national legislation, policy, and research programs. The Recommendation states: ‘Nanomaterial’ means a natural, incidental or manufactured...
April 1, 2022

EC’s Public Consultation on Targeted Revision of the Cosmetic Products Regulation Includes Review of Nanomaterial Definition

The European Commission (EC) has begun a public consultation on how the Cosmetic Products Regulation could be improved to ensure human health and the functioning of the internal market. According to the EC, the identified shortcomings include “the lack of coherence between legislations on the definition of nanomaterials.” The EC notes that its October 2020 Chemicals Strategy for Sustainability outlines its goal to protect better the public and the environment against...
March 23, 2022

EC Requests SCCS for a Scientific Opinion on “Hydroxyapatite (Nano)”

On March 17, 2022, the European Commission (EC) requested that the Scientific Committee on Consumer Safety (SCCS) prepare a scientific opinion on “hydroxyapatite (nano).” As reported in our April 13, 2021, blog item, SCCS issued a final opinion in 2021 stating that having considered the data provided, and other relevant information available in scientific literature, it “cannot conclude on the safety of the hydroxyapatite composed of rod-shaped nanoparticles for use in oral-care...
February 15, 2022

EC Notifies WTO of Draft Amendment to Cosmetics Regulation to Prohibit Certain Nanomaterials

The European Commission (EC) notified the World Trade Organization (WTO) on February 11, 2022, of a draft amendment to the Cosmetics Regulation regarding the use of certain nanomaterials in cosmetics products. The EC states that the amendment is required to enact the prohibition to use in cosmetic products certain nanomaterials for which the Scientific Committee on Consumer Safety (SCCS) identified a basis of concern. The draft amendment would revise Annex II to the Cosmetics Regulation (list...
January 28, 2022

EC Committee Statement on Emerging Health and Environmental Issues Includes Nanotechnology Organics and Conversion of Micro to Nano Plastics in the Environment

On January 21, 2022, the European Commission’s (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published a second statement on emerging health and environmental issues. SCHEER members have identified nine emerging issues in the non-food area as having a potential impact on human health and/or the environment in the future and have given them overall prioritization scores (*, 1, 2, or 3, where * is uncertain and three is high). The emerging issues...
January 14, 2022

EC Adopts Ban on Use of Titanium Dioxide (E171) as a Food Additive

The European Commission (EC) announced on January 14, 2022, that it adopted a ban on the use of titanium dioxide (E171) as a food additive. The ban will apply after a six-month transition period, and beginning summer 2022, this additive should no longer be added to food products. According to the EC, titanium dioxide “is used to impart white colour to many foods, from baked goods and sandwich spreads to soups, sauces, salad dressing and food supplements.” The...
December 17, 2021

EC Denies Authorization of Titanium Dioxide (E171) as a Feed Additive for All Animal Species, Requires Products Be Withdrawn from the Market in 2022

The European Commission (EC) published a regulation on November 30, 2021, in the Official Journal of the European Union that denies the authorization of titanium dioxide (E171) as an additive in animal nutrition, in the additive category “sensory additives,” and in the functional group “colourants: substances that add or restore colour in feedingstuffs.” Under the regulation, existing stocks of the additive must be withdrawn from the market by March 20, 2022....
October 13, 2021

EC Standing Committee Approves EC Proposal to Ban Use of Titanium Dioxide (E171) as a Food Additive

The European Commission (EC) announced on October 8, 2021, that the Standing Committee on Plants, Animals, Food and Feed approved the EC’s proposal to ban the use of titanium dioxide (E171) as a food additive. The EC states that its proposal “is based on a scientific opinion by the European Food Safety Authority, which concluded that E171 could no longer be considered as safe when used as a food additive, in particular due to the fact that concerns regarding...
September 10, 2021

SCHEER Questions Whether Draft EQSs for Silver and Its Compounds Should Address Silver Nanomaterials

On September 7, 2021, the European Commission (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) posted a preliminary opinion on “Draft Environmental Quality Standards for Priority Substances under the Water Framework Directive” for silver and its compounds. The Water Framework Directive requires the EC to identify priority substances among those presenting significant risk to or via the aquatic environment and to set environmental quality standards (EQS) for...
August 30, 2021

EC Analyzing Responses to Targeted Stakeholder Consultation Concerning Review of Recommendation on the Definition of a Nanomaterial

As reported in our May 7, 2021, blog item, the European Commission (EC) held a targeted stakeholder consultation as part of its review of the Recommendation on the definition of a nanomaterial. The EC held the consultation to update, test, and verify the preliminary findings of its review, gathering further evidence and feedback from a wide range of stakeholders who have a role in application of the harmonized regulatory definition of nanomaterial in the European Union (EU)....
July 29, 2021

France Seeks More Protective European Definition of Nanomaterials

As reported in our May 7, 2021, blog item, the European Commission (EC) recently held a targeted stakeholder consultation to update, test, and verify the preliminary findings of its review of the 2011 Recommendation on the definition of a nanomaterial. According to a July 23, 2021, news item posted by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES), in its response to the consultation, ANSES maintained that the changes proposed by the EC...
July 28, 2021

EC Publishes Report on Use of Nanomaterials in Cosmetics and Review of Cosmetics Regulation Regarding Nanomaterials

Pursuant to Article 16 (10) and (11) of Regulation (EC) No 1223/2009 (Cosmetics Regulation), the European Commission (EC) is required to submit to the European Parliament and the Council an annual status report on the use of nanomaterials in cosmetic products and to review the Regulation’s provisions concerning nanomaterials. The July 22, 2021, report includes the following main findings: The report states that aligning the nanomaterial definition in the Cosmetics Regulation with a...
July 6, 2021

EC Requests Scientific Opinion on Fullerenes and Hydroxylated Fullerenes

The European Commission (EC) has requested a scientific opinion from the Scientific Committee for Consumer Safety (SCCS) on fullerenes and hydroxylated fullerenes. According to the request, the EC has received 19 notifications under Article 16 of the Cosmetics Regulation for cosmetic products containing fullerenes and hydroxylated fullerenes. The request states that these ingredients “are reported in CosIng database with the function of ‘antimicrobial’ and ‘skin...
July 1, 2021

Council of the EU Adopts Conclusions on Chemicals to Offer Political Guidance on Sustainable EU Chemicals Policy Strategy

On June 26, 2019, the Council of the European Union (EU) announced that it adopted conclusions on chemicals intended to “offer political guidance on the development of a sustainable EU chemicals policy strategy.”  The June 26, 2019, press release notes that the conclusions address in particular the topics of Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, endocrine disruptors, nanomaterials, and pharmaceuticals.  According to the...
July 1, 2021

EC Committee Needs More Data to Assess Safety of the Nanomaterials Gold, Colloidal Gold, and Surface Modified Gold

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published a final opinion on June 28, 2021, on gold (nano), colloidal gold (nano), gold thioethylamino hyaluronic acid (nano), and acetyl heptapeptide-9 colloidal gold (nano). The EC asked SCCS whether the nanomaterials gold, colloidal gold, gold thioethylamino hyaluronic acid, and acetyl heptapeptide-9 colloidal gold are safe when used in leave-on skin cosmetic products according to the maximum concentrations and...