COVID-19 Regulatory Developments: Update 7
The outbreak of the COVID-19 pandemic has resulted in countries adapting their regulatory landscape to accommodate and mitigate the unprecedented disruptions to companies and individuals. Through regular updates, Compliance & Risks will closely monitor the situation and inform our clients of the latest global regulatory developments in relation to COVID-19 relevant to their topics, along with updates on items which may be of interest outside our topics.
Regulators across the globe are working relentlessly to curb the outbreak of COVID-19. Various European and International Authorities, including UNECE and the Intergovernmental Organization for International Carriage by Rail (OTIF) have taken measures to reduce pressures on businesses by granting special derogation, deadline extensions and deferring the expiry date of certain certificates. Our regulatory news feed is constantly updated to take into account the escalating number of measures related to COVID-19.
In Colombia, a Safety Protocol has been released for companies involved in the manufacturing industry. This Protocol aims to guide the manufacturing industry on the appropriate measures to be taken in order to decrease the transmission risk of COVID-19 in their activities. This Protocol was issued in addition to the general national safety protocol provided in Resolution No. 666/2020.
This Protocol provides general measures to be taken by all companies involved in manufacturing products within Colombia. Specific measures are provided for those involved in the manufacturing of textiles, chemicals and EEE products. The measures included in the Protocol are largely procedural and organizational in nature and cover equipment, staff, product handling, and distribution, among other aspects.
REACH and Chemicals Management
The European Chemicals Agency has issued a number of deadline extensions, starting with the deferral of deadlines to complete technical completeness checks of registration dossiers. Companies that initially failed to provide a complete registration and had a final deadline to submit information to ECHA between March and May 2020, will have an additional two months to finalize their submissions. Similarly, the start of completeness checks of chemical safety reports has been postponed until October 2020.
Companies who have submitted confidentiality claims in accordance with the REACH Regulation and were required to provide further information between March and May 2020 will also benefit from an additional two months to submit the requested information to the Agency.
Additionally, an extension of 30 days has been granted to companies receiving draft decisions from ECHA under the REACH Regulation. The additional 30 days will apply to submission of comments on draft decisions issued as a result of a testing proposal examination under Article 40 of REACH Regulation, compliance check (Article 41), follow-up to dossier evaluation (Article 42(1)) and substances evaluation (Article 46). All deadline extensions can be consulted here.
Transport of Dangerous Goods
In light of COVID-19, OTIF released a series of Multilateral Special Agreements postponing the expiry date of periodic inspections and tests of tanks, UN multiple-element gas containers and pressure receptacles for the carriage of gases. It has been decided that all periodic or intermediate inspections of tanks, the validity of which ends between 1 March 2020 and 1 August 2020, will remain valid until 30 August 2020. The validity period of certain certificates issued under the Regulation concerning the International Carriage of Dangerous Goods by Rail (RID) has also been extended until 30 November 2020. This primarily concerns safety adviser certificates for the transport of dangerous goods that expire between 1 March 2020 and 1 November 2020. The validity of these certificates shall be extended by five years starting from the date of their original date of expiry if their holders have passed an examination in accordance with 188.8.131.52.2 of RID before 1 December 2020.
COVID-19 also prompted the UNECE to extend certain deadlines for periodic inspections and controls of gas containers including multiple-element gas containers, tank and portable tank under the ADR (European Agreement Concerning the International Carriage of Dangerous Goods by Road). Perhaps less than expected was the decision to exempt the collect of certain sanitizers, hydro-alcoholic gels and solutions from the provision of ADR. The exemption is subject to specific packaging requirements and only concerns products covered by the following UN number:
- UN 1170, Ethanol or Ethanol in solution, class 3, packing group II or III
- UN 1219, Isopropyl alcohol, class 3, packing group II
- UN 1987, Alcohol n.o.s., Class 3, Packing Group II or III
- UN 1993, Flammable Liquid n.o.s., Class 3, Packing Group II or III
The validity period of all ADR Driver Training Certificates has been extended until 30 November 2020. These certificates will be renewed for five years if the driver furnishes proof of participation in refresher training and has passed an examination before December 1, 2020. For further information, please consult UNECE’s Multilateral Agreement M324. Against this momentum, the Ministry of Transport of the Russian Federation confirmed that certificates, which were due to expire between 1 March and 1 November 2020, will remain valid until 30 November 2020.
The Peruvian Ministry of Energy and Mines announced an extension to the enforcement deadline for the submission of certificates of conformity for products listed in paragraphs c, d, e, f and g of Article 1.1 of Supreme Decree No. 009-2019-EM. The new compliance deadline for the submission of conformity certificates is now 24 September 2020. The extension of deadline only applies to the following products:
- Refrigeration appliances for domestic use
- Household clothes washers
- Domestic drum dryers
- Air conditioning equipment
- Instant water heaters for domestic use, which run on gaseous fuels
Occupational Health and Safety
In Germany, the Federal Ministry of Labor and Social Affairs (BMAS) published SARS-CoV-2 Occupational Safety and Health Standard (SARS-CoV-2-Arbeitsschutzstandard). The important points of the Standard include the requirement to maintain physical distancing of 1.5m between each employee and establish transparent partitions in workplaces and other places frequented by the public. Practical organizational measures are recommended to ensure adequate safe distancing and deal with suspected cases of COVID-19. The recommendations suggest the number of individuals in work areas and communal facilities must be reduced by measures to spread utilization over time (staggered working and break times, or if necessary, shift working), strict care of the storage and cleaning of PPE and work clothing, and the reduction of outside access. The standard also contains provisions to assist employers with implementing remote working policies, and requires infection controls for building sites, farms, field service staff and delivery services.
EU level guidance is also available to help employers assess and develop preventive measures to achieve a safe ‘return to work’ following the relaxation of lockdown restrictions.
Developments for medical supplies
To meet the global demand for medical supplies, the EU Commission has reached decisions on harmonized standards for medical devices under the Medical Device Directive and Directives on active implantable medical devices and in-vitro diagnostic medical devices. Compliance with harmonized standards confers presumption of conformity with legislative requirements and facilitates unhindered market access for PPE products that ensure a high degree of safety. A list of harmonized standards can be accessed via the following links:
Latvia has clarified its procedure for issuing export authorization for Ethyl Alcohol. In a Ministerial Order dated 25 April 2020, the Minister of Economics clarified that merchants who have a valid authorization issued by the State Revenue Service for the purchase of ethyl alcohol for the manufacturing of disinfectants shall provide the Ministry with information on the missing amount of ethyl alcohol for the next two weeks. Merchants who have an approved permit for the operation of an approved warehouse shall submit an application to the Ministry of Economics prior to exporting ethyl alcohol outside the country. The application shall contain: the code of the ethyl alcohol in conformity with the Combined Nomenclature of the EU, the quantity intended to be exported, the country of destination, contact details of the person to which the authorization will be directed, and a copy of the contract for the supply of ethyl alcohol.
Recognizing that many Canadian entities and industries not currently regulated by Health Canada have expressed an interest in providing additional or alternative sources of ethanol, Health Canada issued an Interim Guide to Producing Ethanol for Use in Alcohol-Based Hand Sanitizers. This document provides insightful information on the use of ethanol as an ingredient in alcohol-based hand sanitizers sold in Canada. The Interim Guide covers aspects relating to:
- Acceptable quality levels
- Recommended formulation
- Non-medicinal ingredients (NMI)
- Substitutions of formulas
- Use of alcohol other than that of the USP
- Implications of Excise Duties
- Obtaining an approved license, registration or formulation under the Excise Act…
- End of the interim approach
This Guide is a follow-on to the Guide on Health Canada’s interim expedited licensing approach for the production and distribution of alcohol-based hand sanitizers. The purpose of this guide is to assist companies that intend to manufacture, package, label and/or distribute alcohol-based hand sanitizers in response to the current shortage, by offering a simplified and accelerated route for obtaining the required authorizations. Further information is available here.
The U.S. Customs and Border Protection has updated its guidelines in accordance with a Presidential Memorandum, in which scarce personal protective equipment (PPE) exported outside the country can be reassigned for domestic purposes. Pursuant to the temporary final rule, the export of the following PPE is subject to prior authorization by the Federal Emergency Management Agency (FEMA):
- N-95 Filtering Facepiece Respirators
- Other Filtering Facepiece Respirators (N99, N100, R95, R99, R100, or P95, P99, P100)
- Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges
- PPE surgical masks
- PPE gloves or surgical gloves
No shipments of such designated materials may leave the United States without explicit approval by FEMA. Exemptions are provided for certain materials explicitly listed here. For certain exemptions duly specified, FEMA requires a letter of attestation to be submitted via the document imaging system (DIS). The exporter, shipper (or their agents) of goods eligible for the exemption should present the letter via DIS, on company letterhead, signed by a responsible company official. The letter must include the following:
- A description of which exemption(s) the exporter is claiming
- Details regarding the shipment that are sufficient for the CBP and FEMA officials to determine whether the shipment falls under the claimed exemption(s), including the required information identified in the Federal Register notice published on 21 April 2020
- A statement that the provided information is true and accurate to the best of the exporter’s knowledge, and that the exporter is aware that false information is subject to prosecution under the DPA, as outlined in the allocation order
Peru has released a series of targeted standards for personal protective equipment:
- Resolución Directoral Nº 006-2020
- Resolución Directoral N° 003-2020
- Resolución Ministerial Nº 239-2020