Weekly Compliance Digest – US GHS Deadline, EU Novel Food Regulation

November 27, 2015 By
In this edition of the Weekly Compliance Digest, we bring attention to an upcoming December 1, 2015 deadline for distributors of chemical products in the U.S., and a proposed update to the EU regulation on Novel Food.

U.S. OSHA Hazard Communication Standard 2012 (HCS 2012) – Chemical Distributors

What is it?

OSHA modified its Hazard Communication Standard (HazCom) in 2012 to align with the UN’s Globally Harmonized System of Classification and Labeling of Chemicals (GHS). HazCom 2012 is being implemented through a number of phase-in effective dates. The most important deadline was June 1, 2015 when chemical manufacturers, importers, distributors and employers had to comply with all modified provisions of the final rule. This included the creation of Safety Data Sheets (SDSs) and labels according to the U.S. adaptation of GHS. However, there was an exception regarding labeling requirements for distributors.

Who is affected?

Distributors of hazardous chemicals that are subject to HazCom 2012 labeling requirements. Note that HazCom 2012 does not apply to the following:

  • Hazardous waste defined by the Resource Conservation and Recovery Act (RCRA)
  • Hazardous substances defined by the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA)
  • Tobacco or tobacco products
  • Wood or wood products
  • Articles (i.e. manufactured items)
  • Food or alcoholic beverages
  • Drugs, under certain conditions
  • Cosmetics, under certain conditions
  • Consumer products defined by the Consumer Product Safety Act (CPSA)

Click here for a complete list of exemptions from The University of Chicago’s Environmental Health and Safety staff.

What are the requirements?

As of December 1, 2015, distributors of hazardous chemicals are required to provide a label that conforms with HazCom 2012. The label must include a harmonized signal word, pictogram, and hazard statement for each hazard class and category. Precautionary statements must also be provided. Chemical manufacturers and importers had a similar requirement that had to be met by June 1, 2015.

What is next?

The December 1, 2015 deadline for distributors is the third of four effective dates defined by HazCom 2012. The last effective date is June 1, 2016. By that date, all U.S. employers will need to update alternative workplace labeling and hazard communication program as necessary, and provide additional employee training for newly identified physical or health hazards.
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Proposed Update to EU Regulation on Novel Food

What is it?

The European Parliament and the Council agreed last week on a proposal for an updated novel food regulation. The European Commission (EC) decided to revise the novel food legislation because the current rules date back almost 20 years.

The updated regulation creates a centralized authorization system that aims to give greater certainty for applicants seeking an authorization for novel food, and simplify and speed up the authorization process.

The European Food Safety Authority (EFSA) will conduct a scientific risk assessment for the novel food application, while the Commission will manage the files of each applicant and put forward a proposal for the authorization of a novel food found to be safe.

To facilitate trade of traditional food from non-EU countries, which are considered novel foods in the EU, the new regulation introduces a more appropriate assessment procedure for food new to the EU, the EC says. If the traditional food can historically be demonstrated as being safe and there are no safety concerns raised by EU Member States or EFSA, then it will be allowed to be placed on the market on the basis of a notification from the company.

Data protection provisions are also included in the new regulation.

Who is affected?

Companies that want to bring novel food into the EU market. Novel food is defined as food that has not been consumed to any significant degree in the EU before May 1997 (when the first novel food legislation entered into force). This can be newly developed, innovative food or food produced using new technologies and production processes, as well as food traditionally eaten outside of the EU.

The novel food regulation does not apply to the following:

  • Food additives
  • Flavourings for use in foods
  • Extraction solvents used in the production of foods
  • GMOs for food and feed
  • Foods and/or food ingredients used exclusively in food supplements (new uses in other foods would require an authorisation)

What are the requirements?

The proposed update simply modifies authorization procedures. The requirements remain the same: Companies must receive authorization to be able to bring novel food into the EU market. In order to be authorized for use in the EU, novel food must:

  • Not present a risk to public health.
  • Not be nutritionally disadvantageous when replacing a similar food.
  • Not be misleading to the consumer.
  • Undergo a scientific assessment prior to authorization to ensure their safety. The authorization sets out:
    • Conditions for use
    • Designation as a food/food ingredient
    • Labeling requirements

What is next?

The new regulation has to be formally adopted by the European Parliament and the Council before its publication in the Official Journal of the European Union. The new rules apply two years from the date of entry into force of the new regulation (around end 2017).
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Categories: EHS

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