ChemRegs Newsletter – June 2020
Illegal and ineffective Hand Sanitisers
Several countries have reported that the COVID-19 pandemic has led to an increased number of non-compliant (hand) disinfectants on the market.
The increased demand for disinfectants to fight the COVID-19 pandemic and the granting of health emergency permits and derogations have attracted many new producers and suppliers to the market. These companies are not always aware of the applicable legal frameworks in place, and although many act in good faith and use all the available help offered by the various agencies and national authorities, some appear to be taking advantage of the situation.
Cases have been recorded of disinfectants that do not have the required authorisation or permit, or lack the correct hazard labelling. Many countries also indicated that they found products that were claiming to be disinfectants but which had a formulation that could not be sufficiently effective against viruses – e.g. due to insufficient concentrations of active substances with virucidal activity that stops the spread of viruses.
This is partly due to manufacturers trying out new mixtures e.g lowering the concentrations of ethanol or isopropanol, due to the shortage of these key ingredients. Other ingredients have been substituted, including methanol, which has a weak ability to kill viruses when compared to other alcohols, but is extremely toxic and can cause blindness and even death if ingested. Methanol is also absorbed through the skin and can result in toxic levels, especially in children.
Some internet shops import products from third countries and then try to sell them for inappropriate uses e.g products intended for disinfecting surfaces are marketed as hand sanitisers, even though the two products have different ethanol levels.
National enforcement authorities are therefore taking action and are performing market inspections, including controls of online sales, to avoid ineffective products marketed to consumers as disinfectants being used against COVID-19. Enforcement actions include fines and the withdrawal of the products from the market.
It is therefore very important to understand the legal requirements before producing/importing and placing hand gels or hand sanitisers on the market.
In the UK you can get more information from the HSE at https://www.hse.gov.uk/coronavirus/hand-sanitiser/index.htm
Other News
New version of CLP Labelling Guidance and draft revision of SDS Guidance
ECHA has published Version 4.1 (May 2020) of the Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008.
This has been updated via fast track to implement the amendment of the legal text due to Commission Delegated Regulation 2020/11 of 29 October 2019 on information relating to emergency health response (Poison Centres). In particular:
- Clarification of labelling requirements with regards to the UFI code in standard situations (in section 4.8.1.1);
- Clarification of labelling requirements with regards to the UFI code in particular cases of fold-out labels, tie-on tags or outer packaging (section 5.3.1);
- Minor changes and clarification in the labelling examples concerning mixtures (section 6).
ECHA has also submitted draft Version 4.0 of the Guidance on the compilation of safety data sheets to be reviewed before publishing. This new version is an update of the guidance to take into account the revised Annex II of REACH that will apply from January 2021. See our December 2019 Newsletter for more information on the new requirements of Annex II.
All current ECHA guidance documents are available on the ECHA website at: https://echa.europa.eu/support/guidance.
For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk