COVID-19 Regulatory Developments: Update 11

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.

Ecodesign and Energy Efficiency

The European Commission has introduced temporary flexibility in the application of recent EU Energy labeling Regulations imposing new labeling requirements for electronic displays, household washing machines, household washer-dryers, refrigerating appliances and household dishwashers (Delegated Regulations (EU) 2019/2013; (EU) 2019/2014; (EU) 2019/2016 and (EU) 2019/2017).

Per these Regulations, suppliers must provide a rescaled label for all products they place on the market and enter the parameters of the new product information sheet in the product database by 1 November 2020. Regulation (EU) 2019/1782 on ecodesign requirements for external power supplies is effective since 1 April 2020. This legislation similarly requires provisions of new nameplates for all products placed on the market as of 1 April 2020.

Manufacturers are facing difficulties to produce or provide rescaled labels or new nameplates due to reduced workforce and increased stockpiling as a result of shop closures during COVID-19. Amid this concern, the Commission has allowed market surveillance authorities to monitor compliance on an ongoing basis with no link to the above-mentioned specific dates to comply with ecodesign requirements for external power supplies and energy labeling requirements for products placed on the market as of 1 November 2020. However, the Commission stresses that, in any event, all current labels in shops will have to be exchanged for rescaled labels from 1 to 15 March 2021, in accordance with Article 11(13) of Regulation (EU) 2017/1369 setting out a general framework for energy labeling 

Electromagnetic Compatibility – Wireless

In a Circular dated 18 May 2020, the Indonesian Directorate General of Post and Telecommunications clarified the certification process for telecommunication devices, with a particular emphasis on test reports, during COVID-19. The Circular contains useful information for those applicants who wish to obtain new certificates for their devices or renew their existing certification. The Circular recalls that “every telecommunication device that is made, assembled, or imported into the territory of Indonesia must be certified”. Already certified devices will need to undergo the recertification process every three years after the expiry of the initial certificate’s effective date. New applications must be duly supported by test result reports or test reports. Where the provision of a full test report is not possible, applicants may submit partial test results (e.g. EMC or RF) provided the results are accompanied by a sufficiently stamped letter stating the applicant’s ability to complete the test report required no later than six months from the effective date of this Circular.

This Circular entered into force on 18 May 2020. It will remain in force until the Indonesian authorities lift the restrictions imposed by the emergency status of COVID-19.

EH&S: Occupational Health and Safety

As noted in our previous update, the European Commission developed a proposal to add SARS-Cov-2 to the list of biological agents that are known to infect humans under Annex III of Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work. This proposal has now become final with the adoption of Directive (EU) 2020/739 of 3 June 2020. The new Directive recalls that the deadline to transpose former Directive (EU) 2019/1833 is 20 November 2021. Commission Directive 2019/18332 added a large number of biological agents to the list of Annex III, including the Severe Acute Respiratory Syndrome-related coronavirus (SARS-virus) and the Middle East Respiratory Syndrome coronavirus (MERS-virus).

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Directive 2020/739 by 24 November 2020.

A Senate Bill was introduced in the United States to protect workers from occupational exposure to COVID-19. The ‘COVID-19 Every Worker Protection Act’ requires that, no later than seven days after the enactment of the Act, the Occupational Safety and Health Administration promulgate an emergency temporary standard to protect employees from occupational exposure to COVID-19. The standard will apply to employees in the health care sector, paramedic and emergency medical exposures and other employees who are at risk of such exposure.

In a similar approach, Peru also developed a legislation proposal to recognize COVID-19 as an occupational disease for qualified jobs that are considered as representing high risk or very high risks of exposure. At first glance, the recognition of COVID-19 as an occupational disease would only concern front-line workers in the health care sector. The presumption of occupational disease means that the worker no longer has the burden to prove a causal relationship between his/her occupational activities and contraction of the disease. The burden is de facto shifted to the employer to prove that the worker’s condition does not result from a work-related exposure. This Bill specifies that failure to implement the control and prevention measures provided for in Resolution No. 329-2020 MINSA approving Technical Standard on Guidelines for the Health Surveillance of Workers at Risk of Exposure to COVID-19 will entail administrative and civil responsibilities of the employer towards the infected employee.

Automotive

On 25 May 2020, the EU Parliament and EU Council approved the EU Commission’s Proposal for a Regulation laying down specific and temporary measures in view of COVID-19 concerning the validity of certain certificates, licences and authorizations, and the postponement of certain periodic checks and training in certain areas of transport legislation. The new Regulation 2020/698 entered into force on 28 May 2020 with application as of 4 June 2020.

As discussed in our 8th COVID-19 Regulatory Developments Update, the text was initially proposed by the European Commission on 28 April 2020. The final text is similar to the original version. It intends to relieve the transport sector from regulatory and administrative barriers by extending deadlines for renewing certificates under certain transport legislation including Directive 2014/45 on periodic roadworthiness tests for motor vehicles and their trailers, and Directive 2003/59/EC related to the qualification and periodic training of drivers of certain road vehicles for the carriage of goods or passengers. With respect to the latter EU directive, it extends for a period of seven months the validity of driver qualification as well as time limits for the completion, by the holder of a certificate of professional competence (CPC), of periodic training which would otherwise expire between February and 31 August 2020. The Regulation is not limited to transport by road and supports the aviation, rail, maritime, inland navigation sector. 

Note that France, Netherlands, Finland, Croatia, Lithuania, Slovakia have decided not to apply certain provisions related to the extension of time limits for the validity roadworthiness certificates (i.e. time limits specified in Article 5(1) and 5(2), Regulation 2020/698). Sweden, Cyprus, Greece, Romania, Luxembourg, Austria. Bulgaria, Malta, Poland and Denmark also notified their intention not to apply certain provisions of Regulation 2020/698. Please consult the Member States’ notices below for further information:

• France, Netherlands, Finland, Croatia, Lithuania, Slovakia
• Sweden, Cyprus, Greece, Romania, Luxembourg, Austria, Bulgaria, Malta
• Poland, Denmark

Medical Supplies and Personal Protective Equipment

The European Commission recently issued a new guidance document to help interested parties verify whether medical devices and personal protective equipment are lawfully placed on the EU market. The guidance recalls a number of key principles under the Medical Device Directive and Regulation on Personal Protective Equipment. Among other things, the Commission has been keen to recall that in order to lawfully place a medical device or PPE on the EU market, the product must bear the CE mark and be accompanied by a Declaration of Conformity issued by the manufacturer. It further clarifies when the intervention of a notified body is required and the legal value of test reports, and recalls the basic characteristics of a valid declaration of conformity and certificates issued by recognized notified bodies (e.g. EC or EU type-examination certificate, a design-examination certificate or a quality management system certificate). Perhaps most importantly, it briefly synthesizes recent derogations introduced by the EU to permit the placing of PPE/medical devices in the context of COVID-19.

On 1 June 2020, the U.S. Federal Food and Drug Administration updated its guidance policy on the preparation of certain hand-sanitizer products during the health emergency. The update reflects new available data on fuel ethanol produced via fermentation and distillation processes and sets out interim limits for impurities such as methanol, acetal, and acetaldehyde that can be tolerated in ethanol for a relatively short period of time. FDA clarified that fuel or technical grade ethanol that does not meet the requirements of the United States Pharmacopeia and Food Chemical Codex may be considered for use in hand sanitizer only if fuel or technical grade ethanol does not contain gasoline or its component, and if the specified interim limits for impurities are not exceeded (i.e. Methanol: NMT 630 ppm; Benzene: NMT 2ppm; Acetaldehyde: NMT 50ppm; Acetal (1,1-diethoxyethane): NMT 50 ppm; Sum of all other impurities NMT 300 ppm). Other interim limits are formulated for acetone (4, 4000 ppm), ethyl acetate (2,200 ppm), amyl alcohol (4, 100ppm) and 1-propanol (1, 000 ppm). N-butanol and other specific substances are also subject to interim levels.  

In Finland, the Agency for Safety and Chemicals (Tukes) announced the continuation, until the end of 2020, of the derogation from the authorization procedure for the use of ethanol in disinfectants. Ethanol produced by manufacturers of ethanol who are not approved by the European Chemicals Agency may be used in hand sanitizer as an exception, provided the ethanol has been produced in Finland or another EU Member State.

The Philippines Food and Drug Administration issued an updated list of notified hand sanitizers and rubbing alcohol products with effect from 3 June 2020.

On 4 June 2020, the Latvia Ministry for Health published a new Order (Order No. 124) which repeals Order No. 68 on the restrictions of exporting of medical products.

In order to assist manufacturers to comply with their obligations under EU law, the Environment Administration of Luxembourg has compiled a list of EU regulatory requirements for hand-sanitizers.

Argentina released a number of critical Resolutions with respect to PPE such as N95 respirators, non-surgical/surgical chinstraps and other medical supplies. Resolution 144/2020 limits the commercialization of N95 and, or, surgical or TRI-CAPA chinstraps to healthcare professionals and personnel of healthcare services. It also sets out a maximum price of forty pesos per unit for the distribution of these items during the period of health emergency.