In this feature Caroline Raine discusses the coronavirus (COVID-19) and the dispensations that may be allowed to help to support the chemical industry.
The coronavirus (COVID-19) is fast spreading and is providing daily challenges to the supply chain. Medical supplies, hand sanitiser, loo roll and groceries are all in high demand! The government is working hard to help keep goods moving and getting to us.
European Chemicals Agency
The European Chemicals Agency (ECHA) has vowed to support EU-wide action against COVID-19. Working with the European Commission, ECHA promises to support Member States and industry in addressing disinfectant shortages and will also extend some of its deadlines to help chemicals companies.
Bjorn Hansen, ECHA’s Executive Director says: “It is essential to ensure that there are enough disinfectants available for health professionals and European citizens. The main limiting factor seems to be the availability of active substances used in these biocidal products — in particular isopropanol, 1-propanol and ethanol. We are working, together with the Commission, on special arrangements to help Member States and companies get more disinfectants on the market as soon as possible.”
ECHA have extended deadlines, payment terms have been extended by in some cases 2 months. Draft decisions will open for comment for an extra 30 days. Companies that have deadlines falling between March and May will have them extended by 2 months.
Article 55 of the BPR
Article 55 of the Biocidal Products Regulation (BPR) allows Member States to make available on the market products that are not authorised in accordance with the BPR. This is acceptable for a short period of time during cases of danger to public health, animal health or the environment which cannot be contained by other means.
Article 55 states:
Derogation from the requirements
By way of derogation from Articles 17 and 19, a competent authority may permit, for a period not exceeding 180 days, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use under the supervision of the competent authority, if such a measure is necessary because of a danger to public health, animal health or the environment which cannot be contained by other means.
The competent authority referred to in the first subparagraph shall, without delay, inform the other competent authorities and the Commission of its action and the justification for it. The competent authority shall, without delay, inform the other competent authorities and the Commission of the revocation of such action.
On receipt of a reasoned request from the competent authority, the Commission shall, without delay and by means of implementing acts, decide whether, and under what conditions, the action taken by that competent authority may be extended, for a period not exceeding 550 days. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).
By way of derogation from point (a) of Article 19(1) and until an active substance is approved, competent authorities and the Commission may authorise, for a period not exceeding three years, a biocidal product containing a new active substance.
Such a provisional authorisation may be issued only if, after dossiers have been evaluated in accordance with Article 8, the evaluating competent authority has submitted a recommendation for approval of the new active substance and the competent authorities which received the application for the provisional authorisation or, in the case of a provisional Union authorisation, the Agency, consider that the biocidal product is expected to comply with points (b), (c) and (d) of Article 19(1) taking into account the factors set out in Article 19(2).
If the Commission decides not to approve the new active substance, the competent authorities which granted the provisional authorisation or the Commission shall cancel that authorisation.
Where a decision on the approval of the new active substance has not yet been adopted by the Commission when the period of three years expires, the competent authorities which granted the provisional authorisation, or the Commission, may extend the provisional authorisation for a period not exceeding one year, provided that there are good reasons to believe that the active substance will satisfy the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2). Competent authorities which extend the provisional authorisation shall inform the other competent authorities and the Commission of such action.
By way of derogation from point (a) of Article 19(1), the Commission may, by means of implementing acts, allow a Member State to authorise a biocidal product containing a non-approved active substance if it is satisfied that that active substance is essential for the protection of cultural heritage and that no appropriate alternatives are available. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 82(2). A Member State wishing to obtain such a derogation shall apply to the Commission, providing due justification.
This derogation has been used by Germany. The German Federal Agency for Chemicals is temporarily allowing hand disinfectants containing 2-propanol which are not authorised to be placed on the market. The derogation is valid until the 31 August 2020 but is restricted to hand disinfectants with a specific formula as recommended by the World Health Organisation (WHO).
Many companies that don’t normally make alcohol-based hand gels are starting to make them to help with the demand. Many of them are breweries and distilleries. BrewDog, Leith Gin, Verdant Spirits and Pernod Ricard are all helping to manufacture hand gels. As is Anheuser-Busch, best known for Budweiser. And many distilleries are making hand sanitizer with their alcohol and are providing it free.
The Department for Transport (DfT) is also working hard to ensure that the regulations are not preventing anyone from doing their jobs.
The UK has countersigned Multilateral Agreement M324 concerning driver training certificates in accordance with 188.8.131.52.2 of ADR and safety adviser certificates in accordance with 184.108.40.206 of ADR.
This allows those ADR drivers and DGSAs whose qualifications expire between the 1 March 2020 and the 1 November 2020 to remain valid until the 30 November 2020.
Drivers hours have also been extended through a temporary relaxation of the enforcement of the drivers’ hours rules. This is for drivers who deliver essential items to retailers those involved in the delivery of food, non-food (personal care and household paper and cleaning) and over the counter pharmaceuticals. It is valid from Wednesday 18 March 2020 to 23:59 on Thursday 16 April 2020.
This relaxation applies solely to drivers involved in the supply of food and other essential products to supermarkets. This includes the movement of such goods from importers, manufactures and suppliers to distribution centres. It does not apply to drivers undertaking deliveries directly to consumers.
COVID-19 is real and is spreading.
The authorities are working hard to ensure that the regulations are not preventing essential goods getting to those who need it most.
We must continue to play our part by following government guidance.
Last reviewed 24 March 2020