Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.

By Lynn L. Bergeson

On May 12, 2021, from 3:30 p.m. to 5:00 p.m. (EDT), the European Commission (EC) Helpdesk will host a webinar on appropriate Intellectual Property (IP) rights for biotechnology inventions.  The 60-minute webinar will provide an overview of:

  • Relevant IP rights;
  • Product development IP context;
  • IP specifics in biotechnology;
  • IP portfolio development; and
  • IP portfolio management.

The webinar is free of charge, but registration is required.  Additional information is available here.


 

By Lynn L. Bergeson

Under Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Chemicals and Polymers). The amount of the fee is dependent on the annual sales in Canada for the notifier, the specific Schedule being submitted, and other services being requested (e.g., confidential search on the Domestic Substances List (DSL) or Non-Domestic Substances List (NDSL) or masked name application). As of April 1, 2019, Environment and Climate Change Canada (ECCC) modifies NSN fees annually based on the country’s Consumer Price Index (CPI). Based on a decrease in Canada’s CPI over the past 12 months, fees for NSN submissions will decrease by 0.2% starting April 1, 2021. ECCC has posted a revised fees table, effective April 1, 2021, to March 31, 2022.


 

By Lynn L. Bergeson

Under Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Chemicals and Polymers). The amount of the fee is dependent on the annual sales in Canada for the notifier, the specific Schedule being submitted, and other services being requested (e.g., confidential search on the Domestic Substances List (DSL) or Non-Domestic Substances List (NDSL) or masked name application). As of April 1, 2019, Environment and Climate Change Canada (ECCC) modifies NSN fees annually based on the country’s Consumer Price Index (CPI). Based on a decrease in Canada’s CPI over the past 12 months, fees for NSN submissions will decrease by 0.2% starting April 1, 2021. ECCC has posted a revised fee table, effective April 1, 2021, to March 31, 2022.

Tags: Canada, NSN, Fees

 

By Lynn L. Bergeson 

On February 23, 2021, the European Agency for Safety and Health at Work (EU-OSHA) announced that in association with other relevant Directorates-General (DG) of the European Commission (EC), DG Environment has opened a call for applications to select members for an expert group, the High-Level Roundtable on Implementation of the Chemicals Strategy for Sustainability. According to EU-OSHA, the expert group’s mission “is to set the Chemicals Strategy for Sustainability objectives and monitor its implementation in dialogue with the stakeholders concerned.” Specific tasks include contributing to identifying and addressing social, economic, and cultural barriers to the transition toward safe and sustainable chemicals. The expert group will act as a core group of ambassadors to facilitate discussions and promote this transition in the economy and society, developing a regular exchange of views, experiences, and good practices between the EC and stakeholders on the main objectives of the Strategy, namely:

  • Innovating for safe and sustainable chemicals, including for materials and products;
     
  • Addressing pressing environmental and health concerns;
     
  • Simplifying and consolidating the legal framework;
     
  • Providing a comprehensive knowledge base on chemicals; and
     
  • Setting the example for global sound management of chemicals.

The expert group will consist of up to 32 members, with a maximum of:

  • The member state holding the Presidency of the Council of the European Union;
     
  • Ten third-sector organizations in the following areas: health protection, environmental protection, human rights, animal protection, consumer rights, and workers’ rights;
     
  • Eight scientific organizations, academia, and research institutes providing a suitable balance between expertise in fundamental research, applied research, and training/education;
     
  • Ten industries, including small- and medium-sized enterprises (SME) or associations of enterprises, including an adequate representation of frontrunners in the production and use of safe and sustainable chemicals. Those should include chemical industries, downstream users (from different sectors), and retailers; and
     
  • Three international organizations -- the Organization for Economic Cooperation and Development (OECD), the World Health Organization (WHO), and the United Nations Environment Program (UNEP).

Interested organizations are invited to submit their applications before March 18, 2021.


 

By Lynn L. Bergeson 

The United Kingdom (UK) completed its withdrawal from the EU on December 31, 2020, and, as of January 1, 2021, is a “third country” from the EU perspective. Companies worldwide must be aware of the significant implications for compliance under the following newly established independent chemical regulatory regimes: the Great Britain (England, Scotland, and Wales) (GB) Biocidal Products Regulation (GB BPR); the GB Classification, Labeling, and Packaging Regulation (GB CLP); the GB Prior Informed Consent (PIC) Regulation (GB PIC); Regulation (EC) 1107/2009 concerning plant protection products (PPP); and the UK REACH Regulation. On February 5, 2021, the UK Health and Safety Executive (HSE) provided a brief overview of the new chemical regulatory regimes and links to resources available online. Further information is available in The Acta Group’s, B&C’s affiliate, February 9, 2021, memorandum.

Tags: UK, UK REACH

 

By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On December 19, 2020, the Government of Canada’s Department of the Environment published a proposed rule titled Clean Fuel Regulations. The proposed rule addresses Canada’s concerns in achieving its net-zero emissions by 2050 under the Paris Agreement. In an effort to reduce the largest sources of greenhouse gases (GHG), the Clean Fuel Regulations would require liquid fossil fuel primary suppliers to reduce the carbon intensity (CI) of the liquid fossil fuels they produce in and import into Canada from 2016 CI levels by 2.4 g of CO2/megajoule (MJ) in 2022, increasing to 12 g of CO2/MJ in 2030. The proposed rule would also establish a credit market whereby the annual CI reduction requirement could be met via three main categories of credit-creating actions:

  • Actions that reduce the CI of the fossil fuel throughout its life cycle;
  • Supplying low-carbon fuels; and
  • Specified end-use fuel switching in transportation.

The Clean Fuels Regulations would also retain the minimum volumetric requirements of at least five percent low CI fuel content in gasoline and two percent low CI fuel content in diesel fuel and light fuel oil that are currently set out in the federal Renewable Fuels Regulation (RFR). The RFR would be repealed, and parties that are not primary fossil fuel suppliers would be able to participate in the credit market as voluntary credit creators by completing certain actions. Further details are available here.


 

By Lynn L. Bergeson

The government of Manitoba, Canada, is currently working to amend three regulations under the Biofuels Act. The amendments will update Manitoba’s clean fuel standards by increasing the ethanol and renewable fuel content in gasoline. The proposed amendments include:

  • “Ethanol General Regulation is amended to:
     
    • Include the latest fuel standards for ethanol blended gasoline;
       
    • Remove the quarterly reporting requirements of obligated entities; and
       
    • Increase ethanol content from 8.5% to 10%.
       
  • Biodiesel Mandate for Diesel Fuel Regulation is amended to:
     
    • Increase renewable fuel content of diesel from 2% to 5%;
       
    • Adjust the compliance formula to reflect the 5% blending requirement; and
       
    • Adjust the shortfall calculation to reflect the 5% blending requirement, and to increase the penalty amount from $0.45 to $1.50 per litre.
       
  • Biodiesel (General) Regulation is amended to:
     
    • Repeal the definition of “non-commercial licence;
       
    • Include the latest fuel standards for biodiesel and renewable diesel sold or offered for sale in Manitoba;
       
    • Include the latest fuel standards for biodiesel blends eligible under the Biodiesel Mandate;
       
    • Remove the non-commercial biodiesel manufacturing licence class;
       
    • Clarify the conditions required to hold a commercial biodiesel manufacturing licence; and
       
    • Remove references to the non-commercial licence class.”
       

The primary public policy objective of Manitoba’s government is to reduce greenhouse gas (GHG) emissions while increasing renewable fuels use. The regulatory amendments will come into force on January 1, 2021.


 

By Lynn L. Bergeson

On October 8, 2020, the European Commission (EC), under the European Union (EU) State aid rules, approved the prolongation of tax exemptions for biofuels in Sweden. Having exemptions for liquid biofuels from energy and carbon emissions taxation since 2002, Sweden’s scheme aims to increase biofuels use while reducing the fossil fuels use in transport. With EC’s decision, the tax exemption has now been prolonged by one year from January 1, 2021, until December 31, 2021. EC stated that the tax exemptions are not only appropriate, but necessary for stimulating the production and consumption of domestic and imported biofuels in Sweden. In addition, EC found that the Swedish scheme will contribute to the delivery of the EU’s goals in the Paris Agreement and EU’s move towards its 2030 renewables and carbon emissions targets.


 

By Lynn L. Bergeson

The Ministry of Industry and Trade of the Russian Federation formally announced that the May 1, 2020, deadline to submit substances and mixtures to its chemical inventory is extended to August 1, 2020.

Entities exporting products to the Russian Federation should nominate their substances and mixtures to the Russian chemical inventory to ensure continued access to the Russian market. New substance registration is required for substances or mixtures not on the inventory after the nomination process closes.

A company without a legal entity in Russia can appoint an Authorized Representative (AR) to submit information on its behalf and cover importation by its customers in the region. The appointment of an AR and timely submission allow a non-Russian company to maintain an uninterrupted supply chain into the region and support its Russian customers.

More information is available in The Acta Group’s (Acta®) April 2, 2020, memorandum, “Russian Federation Accepting Nominations to New Chemical Inventory,” as well as Acta’s website. Acta’s “Eurasia REACH: Achieving Timely Compliance with New Chemicals Requirements” webinar on May 27, 2020, will provide an overview of the Eurasian Economic Union (EAEU) Technical Regulation (TR) EAEU 041/2017 (Eurasia REACH) and its implementation status, including insights into the Eurasian regional political dynamics and impacts to implementation, and cover the requirements for submitting substances and mixtures to the Russian chemical inventory. Registration for the webinar is still open. Acta assists clients with AR appointment and provides broad-based, hands-on support in the Russian Federation to support its clients’ regulatory compliance and business success.


 

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On April 10, 2020, the European Commission (EC) announced the launch of its new online service that connects crop and food producers with biorefineries. This European Union (EU) project aims to address food waste by enabling crop producers, food processors, and agricultural cooperatives to sell their waste as feedstock for use by two biorefineries in Spain and Italy. The multi-feedstock biorefineries, designed by Agrimax, convert farming and food processing byproducts into compounds that can be used in biobased food packaging as well as in the biobased chemical and agricultural sectors. Agrimax is an EU-funded project focused on the development and demonstration of high-value products from crop and food-processing waste. Its work develops economically competitive routes to the commercialization of the products. The project is expected to end in September 2020; developers hope to make a positive impact in growth of the biobased and agricultural sectors.


 
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