Europe
Highlights from ECHA
R4BP 3.26 release
On April 29th, R4BP 3.26 was released.
Best practice and known issues in SPC IUCLID preparation
The ECHA website reports the best practices and issues on SPC IUCLID transition.
Following the launch of SPC IUCLID in February 2024, ECHA has been collecting feedback on issues that require clarification. The summary document is available here; it lists
the issues encountered and provides potential solutions or additional explanations where necessary.
This document may be helpful if you are experiencing issues with the preparation or amendment of an SPC in IUCLID. It is intended for both industry and authority users.
VEGA and other in-silico tools developed by Istituto di Richerche Famacologiche Mario Negri
ECHA has released training on VEGA and other in-silico tools developed by the Istituto di Richerche Famacologiche Mario Negri (Milan, Italy). The training presents QSAR models and read-across tools to predict chemical properties and toxicity.
Highlights from Coordination group (CG)
CG-54_e_c: Use of the term “as required” for the application frequency
Last April the document GC-54_e_c was published in the Public part of the GC.
For product authorisation, the use/application frequency (“Number and timing of application”) has to be provided in the SPC and the PAR.
The application frequency, e.g. expressed in applications per day, determines how often the product is applied and is a crucial input parameter especially for human exposure assessment. The exposure is calculated based on a certain number and a certain amount of applications per time, which should reflect realistic worst-case assumptions, and which is a relevant input parameter for systemic health exposure and risk assessment.
The term ‘as required’ provides neither helpful information for the user, nor use instructions for safe application.
Thus, the term ‘as required (or similar terms, e.g. ‘daily use’) for determination of typical number of applications per day, shall be no more accepted by the member states without further justification.
Highlights from European Commission
Nitrogen generated from ambient air is in Annex I to Regulation (EU) No 528/2012, in Category 2.
On May the 6th the COMMISSION DELEGATED REGULATION (EU) 2024/1290 was published. It will enter into force on May the 26th.
Applications for product authorisations of nitrogen generated from ambient air, will benefit from a simplified authorisation and shall include evidence that exposure of the user and the general public to a hypoxic atmosphere is avoided and, where appropriate, the necessary measures are taken.
Further extension of the duration of the work programme for the systematic examination of all existing biocidal active substances
On May the 22nd the COMMISSION DELEGATED REGULATION (EU) 2024/1398 was published.
It amends Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards a further extension of the duration of the work programme for the systematic examination of all existing biocidal active substances.
Article 1 says:
In Article 89(1), first subparagraph, of Regulation (EU) No 528/2012, the first sentence is replaced by the following:
‘The Commission shall carry on with the work programme for the systematic examination of all existing active substances commenced in accordance with Article 16(2) of Directive 98/8/EC with the aim of achieving it by 31 December 2030.’
United Kingdom
The UK Government, Welsh Government, Scottish Government and the Northern Ireland Executive are all committed to tackling plastic pollution and its impact on the environment, economy and health. Across the UK, they have introduced bans on a range of unnecessary single-use plastic items among them they proposed a ban on the manufacture, supply and sale of wet wipes containing plastic.
The government has listened to stakeholders to recognise the size of the wet wipes manufacturing industry in the UK. With this in mind, and in line with other recent single-use plastic bans, they have decided not to include manufacture as part of the ban.
Manufacturers in the UK will be able to continue to export wet wipes containing plastic to other countries who do not have the same restrictions but will not be able to supply and sell these in the UK (unless for exempted purposes).
After the ban there will be an 18-month transition period to allow manufacturers adequate time to transition to producing plastic-free wet wipes. The transition period should mitigate economic impacts of the ban, including job losses, and prevent excess stocks of wet wipes containing plastic from being incinerated or landfilled.
The government anticipates legislation to be in place across the UK by the end of 2024.
The intention to ban wet wipes containing plastic, has been expressed in various government strategies, so most manufacturers have commenced the transition to producing plastic-free wet wipes already.
Definition of a ‘wet wipe containing plastic’
For the purposes of the ban, a wet wipe will be defined as the following:
“A wet wipe is a non-woven piece of fabric which has been soaked and stored in liquid and which is not designed or intended to be re-used, including but not limited to baby wipes, cosmetic wipes, moist toilet tissues, personal hygiene wipes and wipe-based cleaning products.”
For the purposes of this ban, in England, Scotland and Northern Ireland ‘plastic’ will be defined using the UK REACH definition. This is consistent with the definition used in legislation for other single-use plastic bans.
In Wales, the legislation will use the existing definition included in the Environmental Protection (Single-use Plastic Products) (Wales) Act 2023, which is based on the UK REACH definition.
Under the UK REACH definition of plastic, along with the supporting guidance on monomers and polymers, viscose, lyocell and cotton are not plastic.
The UK REACH definition of plastic includes plastics that are bio-based, biodegradable or compostable. This includes materials such as polyhydroxyalkanoate (PHA) and polylactic acid (PLA). There is currently a lack of evidence these materials consistently break down in real world environments.
Exemptions for industrial and medical purposes
The government acknowledges that for some uses, plastic free alternatives are either unsuitable or unavailable. On this basis an exemption will be provided for the supply and sale of wet wipes containing plastic for industrial and medical purposes.
The full details of these exemptions will be included in regulations and set out in more detail in guidance.
Next steps
UK Government, Welsh Government, Scottish Government and the Northern Ireland Executive will proceed with legislating for the proposed ban as soon as practical.
Each administration will be introducing regulations via their respective legislative mechanisms. Where required, an economic impact assessment will be published alongside this. More detailed guidance for businesses and enforcement officers will be published in due course.
A full review of the ban (including on the scope, range of exemptions and materials included) will be undertaken periodically.
