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. While the demand for loo roll and groceries seems to be more stable, the demand for medical supplies and hand sanitizer along with personal protective equipment remains high! 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.
Flexibility is being given to contributions to consultations related to REACH restrictions, and many are being assessed on a case-by-case basis.
ECHA have provided a series of questions and answers for companies placing disinfectants on the market, along with recommendations for compositional requirements for three active substances to be used in disinfectants. Also, technical equivalence assessments for propan-1-ol and propan-2-ol.
Under the Prior Informed Consent (PIC) Regulation companies have been given an additional two months to provide details on their 2019 imports and exports of chemicals. This must be sent by the end of May 2020. And ECHA are supporting EU countries to export disinfectants to non-EU countries.
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 was first 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). Since Germany many other Member States have also introduced this derogation. National derogations from the normal authorisation procedure may be granted for a period not exceeding 180 days. An extension may be granted, for a period not exceeding 550 days.
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.
A practical guide to help industry during the COVID-19 pandemic has been published. The guide helps companies that manufacture and supply disinfectants as was created by the Cross-Industry Alliance. Members of the Cross-Industry Alliance include A.I.S.E. (International Association for Soaps, Detergents and Maintenance Products), EBPF (the European Biocidal Products Forum, a sector group of CEFIC) and FECC (the European Association of Chemical Distributors).
The guide sets out the main procedures for fast-tracking the availability of disinfectants in order to help fight the pandemic.
Appendix 1 provides an overview of national measures (either under the Article 55 of BPR and/or national laws) that have been adopted in various European countries.
Appendix 2 lists all the active substances approved or under review for PT1 and PT2 at EU level. Further checks by companies with regards to the efficacy against encapsulated viruses, such as corona viruses should however be conducted.
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 18.104.22.168.2 of ADR and safety adviser certificates in accordance with 22.214.171.124 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.
During the COVID-19 outbreak it has been identified that it is difficult for drivers to maintain their Driver CPC periodic training and so The Department for Transport (DfT) has therefore put in place temporary changes to professional driver qualification requirements.
All professional lorry and bus drivers whose Driver Qualification Card (DQC) expire during the period 1 March 2020 to 30 September 2020 can continue driving, they can benefit from an exemption. All drivers should continue to carry their expired DQC during this period.
The UK Civil Aviation Authority (CAA) has provided a temporary exemption from the recurrent training requirements under the Air Navigation (Dangerous Goods) Regulation 2002. They have also approved remote examinations for Category 1 and Category 6 online training courses, using one-to-one online invigilation.
The International Air Trade Association (IATA) have published guidance for operators on COVID-19, specifically around the transport of alcohol-based hand sanitiser. Alcohol-based hand sanitiser is acceptable under the provisions of 126.96.36.199, however, it should be noted that where passengers or crew wish to have the hand sanitiser in their carry-on baggage that the limit of 100 mL or equivalent per item for liquids and gels in accordance with the aviation security provisions applies.
The total net quantity of all such articles carried by each passenger or crew member must not exceed 2 kg or 2 L and the net quantity of each single article must not exceed 0.5 kg or 0.5 L. Release valves on aerosols must be protected by a cap or other suitable means to prevent inadvertent release of the contents.
The Health and Safety Executive (HSE) has produced lots of guidance to support companies, this guidance is wide ranging from the derogations in place through to support in the workplace. There is guidance to protect workers who remained at work throughout the pandemic as well as advice for those returning to work.
Returning to work challenges
For companies keen to get employees back into the workplace they face many challenges, risk assessments must be carried out. Personal Protective Equipment is in short supply. Social distancing will be difficult in many work environments not to mention the fact that whilst so many businesses have been in shut down mode, water systems have been stagnant and so the risk legionella is now very high.
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.
Companies must carry out risk assessments before reopening offices. Taking into account the high risk of legionella due to stagnant water systems.
Last reviewed 20 May 2020