What’s happening with regard to chemical regulations internationally? Here are some updates we’ve prepared for you for April 2022.
EU Parliament adopts environmental objectives until 2030
5 April 2022
The European Parliament has adopted the eighth European Union Environment Action Programme (EAP) that will guide the EU’s environmental policy until 2030 and ensure its alignment with the European Green Deal.
The latest EAP sets the following priority objectives to be achieved by 2030:
See the European Parliament’s press release for more information and further references.
Titanium dioxide (TiO2) – regulatory updates
Titanium dioxide (TiO2), a frequently used substance, is no longer authorized as a food additive but is temporarily allowed for use in medicinal products. This is stipulated in the European Commission’s Regulation (EU) 2022/63 published on 14 January 2022.
Impact on food Industry
Food produced according to the rules applicable before 7 February 2022 can continue to be placed on the market until 7 August 2022. The products can remain on the market after this date until the date of minimum durability or expiry date.
Impact on pharmaceutical industry
Within three years of the date of entry into force of Regulation (EU) 2022/63, the Commission shall review the need to maintain titanium dioxide on the list of food additives for exclusive use as a colorant in medicinal products, or to remove it from this list.
This review should be based on an updated assessment of the European Medicines Agency (EMA) to be performed before 1 April 2024.
Where replacement of titanium dioxide in medicinal products has not taken place or been initiated within this period, only objective verifiable reasons related to the lack of feasibility of its replacement should be considered.
Titanium dioxide is subject to harmonised classification and labelling as a Category 2 carcinogen. The legislation was published on 18 February 2020, and the harmonised classification and labelling has applied since 1 October 2021.
The regulation classifies titanium dioxide as a suspected carcinogen by inhalation and applies to respirable TiO2 particles (containing 1% or more of particles with aerodynamic diameter ≤ 10 μm).
Further regulatory action is under review. ECHA has released a guide for the classification and labelling of titanium dioxide.
Please get in touch with the H2 Compliance chemical team to discuss this subject further.
Identification of substances of very high concern
Consultation period: 04/03/2022 to 19/04/2022
Recommendation for inclusion in the authorisation list
- 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers
- Diisohexyl phthalate
- Orthoboric acid, sodium salt
Consultation period: 02/02/2022 to 02/05/2022
Legislative Review: ‘Chemicals legislation – revision of REACH Regulation to help achieve a toxic-free environment’
Consultation period: 20 January 2022 – 15 April 2022
Legislative Review: public consultation of the review of the RoHS Directive
Consultation period: 10 March 2022 to 2 June 2022