Europe Regulatory News

The European Chemicals Agency (ECHA), on behalf of the European Commission (EC), is running its fifth project under the Instrument for Pre-Accession Assistance (IPA). These projects are targeted a...

The European Chemicals Agency (ECHA), on behalf of the European Commission (EC), is running its fifth project under the Instrument for Pre-Accession Assistance (IPA). These projects are targeted at assisting European Union (EU) candidate countries to prepare for the obligations of EU membership, in this context specifically regarding chemical safety regulations. They have the overall aim to equip candidate countries with the knowledge necessary to fully participate in the implementation of EU chemicals policy and, in the responsibilities that ECHA shares with MSCAs.

Since 2009, ECHA has implemented four IPA projects focused on explanatory and training events for the authorities of Montenegro and Serbia. The Agency's main goal is to provide technical support to develop these countries’ understanding of ECHA's regulatory activities and facilitate the alignment of their national legislations with the EU regulatory framework.

To increase the impact of ECHA’s general support activities (such as site visits, specific training and participation in ECHA events), the Agency has contracted an in-depth assessment of the legal and institutional capacities of both countries.

The main challenges lie with the limited financial, human and IT resources currently available for the accession countries to implement and enforce the REACH, CLP, BPR and PIC regulations. The study recommends strengthening the administrative capacity of the national authorities, ensuring enough financial resources to implement and enforce the legislation, facilitating cooperation with academia as well as increasing communication activities and IT capacity. 

The national plans outline several actions for Montenegro and Serbia as well as EU Member States and ECHA ahead of a future membership. ECHA stands ready to continue supporting the countries through training and capacity building on risk assessment, IT security and tools, and enforcement.

Last update: 2021-03-31

  Biocidal Products Committee(BPC) is a committee of ECHA which forms opinions on the BPR process and each member state appoints one member fo...

Biocidal Products Committee(BPC) is a committee of ECHA which forms opinions on the BPR process and each member state appoints one member for BPC. Members of BPC meet regularly to discuss and the agenda for those meetings are published 21 days before the meeting.  

In the meeting, BPC proposes not to approve four silver compounds saying that the risks for human health, the product-type 4 (food and feed area) are:

• silver zinc zeolite;
• silver zeolite;
• silver copper zeolite; and
• silver sodium hydrogen zirconium phosphate.

Those substances can be found in kitchen utensils since they are all used to prevent cross-contamination. Also, silver copper zeolite and silver sodium hydrogen zirconium phosphate can be found not only in kitchen utensils but also in water because carbon water filters contain silver zinc zeolite and silver zeolite to prevent bacterial growth and when people use that filtered water to cook or drink, they can be exposed. Consequently, All substances have both commercial and non-commercial applications.  

It is concluded that those substances can’t be used as a disinfectant in food and feed area. For the first time, BPC made a decision considering all the exposure to a substance from many sources not only the use in question.  

Last update: 2021-03-31

The European Commission announced the EU Chemicals Strategy for Sustainability on 14th October 2020, as a key commitment policy to the European Green Deal. The ambition of the European Green Deal ...

The European Commission announced the EU Chemicals Strategy for Sustainability on 14th October 2020, as a key commitment policy to the European Green Deal. The ambition of the European Green Deal is to ensure climate neutrality and circular economy by 2050. The chemical strategy is considered one of the most important parts of the Deal, since it ensures safer environment and health. The strategy is anticipated to have a very large impact on chemical industries related to the EU market.

The European Commission recognises the importance of chemicals for better and higher living standards, however given the hazardous properties of chemicals it has been considered of importance to implement further actions in making chemicals safer and more sustainable. The Strategy’s goals can be divided into two groups:

The goals for increased protection of health and environment, which among others include:

- Phasing out harmful substances form consumer products

- Substituting substances of concern in all products,

- Ensure information access on chemical content and its safe use for producers and consumers.

Goals that boost innovation for safer and more sustainable chemicals, which among others include:

• A financial support in ensuring safe and sustainable-by-design chemicals,
• increase enforcement of EU regulations,
• Simplification and accessibility of EU legal framework by the ‘One substance one assessment' process for the risk and hazard assessment of chemicals
• playing a leading role globally by championing and promoting high standards and not exporting chemicals banned in the EU.

At the Chemical Watch conference “Global Chemicals Management towards 2030 and beyond”, the ECHA Executive Director Bjorn Hansen described the Chemical Strategy as “welcomed by ECHA”. Hansen states that the strategy is anticipated to eliminate regulatory information barriers and enhance the reuse of data collected under different regulations. Furthermore, a more harmonized chemical’s database is expected to greatly facilitate the research processes for scientists in Europe. According to Hansen the Chemical Strategy 2030 is intended to review, revise, and clearly articulate the existing policies and enhance efficiency within the chemical regulatory framework.

The ambitious chemical strategy might lead to a “reopening” of the EU REACH. Some central European countries have expressed their worry regarding the potential “reopening”. Their main concern is that excessive amendments to REACH regulation, in relation to the Chemical Strategy, may lead to pressure on the industries. There are more than 50 action plans laid out to be taken before 2024, as a part of the implementation of the strategy. An introduction of new hazard classes for the CLP Regulation is, for example, expected to be implemented already this year (2021).

The final conclusions regarding the strategy’s implementation are, however, expected to be clarified in March at the next Environment Council meeting. The general support of the strategy by the member states nevertheless predicts a general smooth implementation of the strategy.

Update: 2021-01-29

ECHA has added two new substances to the Candidate List of substances of very high concern (SVHCs) for authorization on 19 January 2021. Now the list contains 211 substances in total. These two...

ECHA has added two new substances to the Candidate List of substances of very high concern (SVHCs) for authorization on 19 January 2021. Now the list contains 211 substances in total.

These two substances were added to the Candidate List as they are toxic for reproduction and hence may adversely affect fertility and cause developmental toxicity in offspring. Both the substances are used in products like inks or toners and also used to produce plastics and rubber tires.

ECHA suggests companies notify ECHA under the Waste Framework Directive (SCIP) if their products contain substances of very high concern.

For further details, kindly contact us on sk@reach-onlyrep.eu

Update: 2021-01-19

FCMs regulations are fast-moving to improve the protection of public health. Food contact materials (FCMs) refer to all materials and articles intended to come into contact with food, for example,...

FCMs regulations are fast-moving to improve the protection of public health. Food contact materials (FCMs) refer to all materials and articles intended to come into contact with food, for example, packaging and containers, machinery to process food, kitchenware, tableware. In recent years, the safety of FCMs has become an issue and one of the major concerns is that chemicals can migrate from the materials into food and may adversely affect consumer health or/and influence the quality of the food. In responding to these concerns, EU and other countries have initiated FCMs regulations and the materials/articles must be manufactured in compliance with these regulations.

On 29th April 2020 the European Food Safety Authority adopted a scientific opinion that assigns salicylic acid, styrene and lauric acid, vinyl ester as high priority candidates for re-evaluation. This scientific opinion was issued upon the request of the European Commission to review the substances without a specific migration limit (SLM) in the Plastic Regulation (EU) No 10/2011. These substances were covered by the generic SML of 60 mg/kg of food, but with Regulation (EU) 2016/1416 this SLM was removed. Of these, 179 substances were placed into the low priority group, 102 were into medium priority group and 3 mentioned above into the high priority group for future re-examination of individual chemical. Existing hazard assessments for each chemical on carcinogenicity / mutagenicity / reprotoxicity, bioaccumulation and endocrine disruptor properties were considered for the prioritization procedure. 

On 20th May 2020, the European Commission issued new Farm to Fork Strategy, stating; “The Commission will revise the FCMs legislation to improve food safety and public (in particular in reducing the use of hazardous chemicals), support the use of innovative and sustainable packaging solutions using environmentally-friendly, re-usable and recyclable materials, and contribute to food waste reduction,” The Commission plans to publish the revision in the 4th quarter of 2022.

On 3rd September 2020, the European Union (EU) published Regulation (EU) 2020/1245 to amend and correct Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food. The 15th amendment added new substances to table 1 of Annex I and introduce several changes to Regulation (EU) 10/2011. The significant changes are summarized in table 1 below. The new law has entered into force as of September 23, 2020. In accordance with the transitional provision, plastic materials and articles that were placed on the EU market before March 23, 2021, and that comply with Regulation (EU) 10/2011 as applicable before the entry into force of this amendment may continue to be placed on the EU market until September 23, 2022 and remain on the market until the exhaustion of stocks.

Table 1. Summary of 15th amendment of the Regulation (EU) 10/2011

On 14 September 2020, Denmark notified the WTO Committee on Technical Barriers to Trade of its enactment of an Executive order on safety requirement for toys. The purpose of the executive order is to ...

On 14 September 2020, Denmark notified the WTO Committee on Technical Barriers to Trade of its enactment of an Executive order on safety requirement for toys. The purpose of the executive order is to transpose into Danish law Directive 2019/1922/UE modifying migration limits for aluminium and Directive 2019/1929/UE laying out limit values for formaldehyde.

The two aforementioned Directives amend Directive 2009/48 on the safety of toys in the following manner:

• In point 13 of part III of Annex II to Directive 2009/48/EC (migration limits for toys and components not to be exceeded):

• In Appendix C to Annex II to Directive 2009/48/EC (Specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth) the following entry is added:

EU Member States are required to transpose Directive 2019/1922 by 19 May 2021 and Directive 2019/1929 by 20 May 2021.

On 8 September 2020 the EU Commission notified the WTO Committee on TBT following the publication of a draft Directive amending Directive 2009/48/EC as regards specific limit values for aniline in toy...

On 8 September 2020 the EU Commission notified the WTO Committee on TBT following the publication of a draft Directive amending Directive 2009/48/EC as regards specific limit values for aniline in toys.

In Appendix C to Annex II to Directive 2009/48/EC (Specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth) the following entry is added: