Chemical compliance… what’s happening?

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

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:

• climate change mitigation to attain the 2030 greenhouse gas emission reduction target
• adaptation to climate change
• advancing towards a wellbeing economy that gives back to the planet more than it takes
• pursuing zero-pollution, including in relation to harmful chemicals
• protecting, preserving and restoring biodiversity, and
• significantly reducing key environmental pressures related to the EU’s material and consumption footprints including through EU 2030 reduction targets.

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.

Ongoing consultations

REACH

Identification of substances of very high concern

Substances: 1

• N-(hydroxymethyl)acrylamide

Consultation period: 04/03/2022 to 19/04/2022

Recommendation for inclusion in the authorisation list

Substances: 8

• 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers
• 2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone
• 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one
• Diisohexyl phthalate
• Ethylenediamine
• Glutaral
• Lead
• 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

RoHS Directive

Legislative Review: public consultation of the review of the RoHS Directive

Consultation period: 10 March 2022 to 2 June 2022