Europe Regulatory News

The European Chemicals Agency (ECHA) and the European Food and Safety Authority (EFSA) announced on May 10, 2022, that an ongoing assessment of the health and environmental risks of glyphosate will be...

The European Chemicals Agency (ECHA) and the European Food and Safety Authority (EFSA) announced on May 10, 2022, that an ongoing assessment of the health and environmental risks of glyphosate will be delayed. Glyphosate-based herbicides are the most widely used weedkiller in agriculture.

Under EU Regulation 1107/2009, concerning the placing of plant protection products on the market, active substances must secure approval from the European institutions before they can be used in plant protection products. Said approval is limited in duration  to a maximum of 10 years, although it can be renewed if requested. Both the initial approval and subsequent renewals are decided upon after a process where the Member States and the European Food and Safety Authority review the existing evidence on the substance’s health and environmental impacts.

Currently, glyphosate is undergoing procedures for the renewal of its approval under the plant protection products regulation (for which EFSA is the relevant EU agency), and for its harmonized classification under Regulation 1272/2008, on classification, labelling and packaging of substances and mixtures (handled by ECHA). The current approval for glyphosate under the plant protection products regulation will expire on 15 December 2022. However, the public consultations run by both agencies have seen very high levels of participation which – together with additional information provided by the applicants for the renewal – have added a significant amount of information to the dossier. 

This additional information will be thoroughly considered by the Assessment Group on Glyphosate (AGG), composed of four EU Member States (France, Hungary, the Netherlands, and Sweden). Therefore, EFSA and ECHA are postponing their findings to have enough time to assess the contributions submitted. The revised timeline for the remaining steps in the re-evaluation process and publishing of the assessment is July 2023. 

In light of the above, it is expected that the European Commission will expand the current approval until a decision can be reached based on EFSA’s recommendations. 
 

The European Commission updates the glossary of ingredient names commonly used in cosmetics production. This was done to correct the names of ingredients that were written incorrectly while some were ...

The European Commission updates the glossary of ingredient names commonly used in cosmetics production. This was done to correct the names of ingredients that were written incorrectly while some were updated to comply with the recent changes made in the Personal Care Product Council’s (PCPC’s) International Nomenclature of Cosmetic Ingredients (Inci) list. 

To this effect, companies have to ensure that the chemicals listed on their cosmetic products’ labels comply with the new list. The deadline to do this is April 29, 2023. This is a part of the EU’s vision and strategy for sustainability, which has started by changing certain regulations like this.

 You can access the glossary of the common ingredients’ names here.

The European Chemicals Agency (ECHA), together with the Member States reviewed a group of 148 bisphenols, of which 38 bisphenols have potential reprotoxic or hormonal effects. Bisphenols are common...

The European Chemicals Agency (ECHA), together with the Member States reviewed a group of 148 bisphenols, of which 38 bisphenols have potential reprotoxic or hormonal effects.

Bisphenols are commonly known as endocrine disrupters for human health and the environment. Endocrine disrupters are slow to break down in the environment and it causes adverse effects on human health. According to ECHA, bisphenols are mostly used in manufacturing polymers or polymer resins, thermal paper, adhesives, textiles, and paper.

Since bisphenols are widely used, the recommendation is to enact a group restriction as the best way to manage the risks posed by the 30 bisphenols. Before now, three bisphenols have been identified as Substances of Very High Concern (SVHC). These chemicals are bisphenol A, bisphenol B, and 2,2-bis(4'-hydroxyphenyl)-4-methylpentane. For other group members in bisphenol, there is a need to generate more data before confirming the endocrine-disrupting and reprotoxic properties.

On May 2, 2022, the European Union released a draft to amend Annex XVII to Regulation (EC) No 1907/2006. The new amendment mainly concerns articles in which production includes the use of formaldehyde...

On May 2, 2022, the European Union released a draft to amend Annex XVII to Regulation (EC) No 1907/2006. The new amendment mainly concerns articles in which production includes the use of formaldehyde or formaldehyde-releasing substances that releases the substance into indoor air in concentrations beyond the limit. It also refers to road vehicles that have formaldehyde or formaldehyde-releasing substances added in their productions in which concentration in the vehicles’ interiors is higher than the allowed limit.

The new amendment specifies the limit for wood-based articles and furniture at 0.062mg/m³ and other articles at 0.08mg/m^3. For road vehicles, the restriction is set at 0,062mg/m³. Therefore, concerned products beyond the stipulated concentration limit cannot be placed on the market.

The new restriction is expected to come into force 36 months after its entry (for concerned articles) and 48 months after entry into force for road vehicles.

According to the American Cancer Society, Formaldehyde is an organic compound, a colourless gas with a strong smell used in producing building materials, household products and vehicles. The common way to be exposed to the substance is through inhalation which studies have shown to cause cancer in humans. The main aim of the new restriction is to reduce exposure to formaldehyde and protect the general public from such exposure.

The proposed date of adoption is the last quarter of 2022 and the proposed date of entry into force will be 20 days from its publication in the EU official journal. All comments are expected 60 days (July 1, 2022) from its notification (May 2, 2022).

Exports and products involved with perfluorooctanoic acid (PFOA), its salt forms, and PFOA-related compounds are banned after the European Commission makes addition to Annex V of the Prior Informed Co...

Exports and products involved with perfluorooctanoic acid (PFOA), its salt forms, and PFOA-related compounds are banned after the European Commission makes addition to Annex V of the Prior Informed Consent (PIC) Regulation. Echoing the Stockholm Convention on Persistent Organic Pollutants (POPs), the entry of the chemicals is monitored and this further urges parties concerned to prohibit exports that contain such substances.

In Annex I of the PIC Regulation, export notification requirements for 22 chemicals are at the same time addressed. The regulated range includes 15 pesticides, 7 industrial chemicals, and all substances that contain benzene as a constituent at concentrations above 0.1% weight by weight. Imports of restricted chemicals under the effect of the PIC Regulation were seen to have decreased by 20% over the same period, though the number of substances exported was reported higher than in the previous year according to the European Chemicals Agency (ECHA).

The PIC Regulation amendments were published on April 20, 2022, and will enter into force on July 1, 2022, after which the EU exporters will have to specify their intention of exporting the chemicals listed and receive explicit consent from the import destination before exports take place.

On May 3, 2022, the European Parliament voted on a European Commission proposal to tighten the limits for the presence of Persistent Organic Pollutants (POPs) in waste. The proposal was earlier adopte...

On May 3, 2022, the European Parliament voted on a European Commission proposal to tighten the limits for the presence of Persistent Organic Pollutants (POPs) in waste. The proposal was earlier adopted by the European Commission.

The presence of POPs in waste is a barrier to the development of a circular economy, one of the major objectives of the European Green Deal.

The Commission proposal was presented on 28 October 2021. It would amend Annexes IV and V to Regulation (EU) 2019/1021 on persistent organic pollutants, introducing limits for the presence of the following POPs in waste:

• perfluorooctanoic acid (PFOA) and its salts and related compounds – found in waterproof textiles and fire-fighting foams;
• dicofol – a pesticide, previously used in agriculture;
• pentachlorophenol, its salts, and esters – found in treated wood and textiles

Additionally, it would tighten maximum limits for some POPs already included in the Regulation.

While the Parliament agrees with the overall approach of the Commission’s proposal, it is suggesting more strict maximum limits in order to achieve the vision set out under the European Green Deal’s Zero Pollution Action Plan and Chemicals Strategy for Sustainability.  

Parliament is also proposing that the Commission assess whether it would be convenient to amend EU waste legislation to recognize that waste exceeding the thresholds of the POPs Regulation is hazardous waste.

Negotiations between Parliament and the Council of the EU, representing the Member States, will now begin. Both institutions must agree on a final text, which will then become law.

A leading European research institute, Oeko-Institut opened a consultation to exempt lead restriction under the EU RoHS Directive for medical devices’ production. The expectation is to develop lead-...

A leading European research institute, Oeko-Institut opened a consultation to exempt lead restriction under the EU RoHS Directive for medical devices’ production. The expectation is to develop lead-free alternatives, which have been delayed due to the COVID-19 pandemic.

Representing the European Commission, the institute is assessing the application for use of lead in polyvinyl chloride (PVC) as a thermal stabiliser. Also, it is a base material used in amperometric, potentiometric and conductometric electrochemical sensors, all present in medical devices.

Previously, the EU gave an exemption on the restriction of hazardous substances (RoHS) in electrical and electronic equipment. This exemption expired in March and this new exemption is expected to remain for two years.

This decision was made in consideration of the delay that hospitals experience in using medical devices for patients, mainly to analyse creatinine and blood urea nitrogen in whole blood.

To comment on this consultation, you have till May 19 after which a decision might be made. You can view the exemption request here.