After three years of negotiations, the European Union is nearing the end of a long process to simplify and harmonize the rules for organic food production and the labeling of organic products. Council Regulation (EC) 834/3007 currently defines the minimum standards for organic products that are produced, manufactured, imported into, sold or traded within the EU, as well as the national inspection and certification systems that ensure that these requirements are met.

However, the past decade has seen a 125% growth in the value of the organic food market, with the amount of land used for organic farming growing at around 400,000 hectares per year. The European Commission has now recognized that the current rules need to be updated to support the long term development of organic production in the EU.   One of the key aims of the new regulations will be to ensure that the EU organic logo offers consumers the same guarantee of quality across Europe, including in respect of products imported from outside the EU.

The new rules will:

  • Create an EU-wide set of rules for all organic producers and products. Any necessary exceptions will be limited in time, regularly assessed and applied to all producers to ensure fair treatment.
    Apply equally to non-EU farmers who export their goods to the EU, phasing out the 60+ different “equivalence” standards currently applying to imported organic foods and levelling the playing field between EU and non-EU producers.
  • Enable farmers to apply for group certification for their products, thereby reducing costs and making it easier to join the organic scheme.
  • Apply to new products like salt, cork and essential oils and enable further products to be added in response to consumer demand.
  • Allow national authorities the discretion to reduce controls and inspections on farms from every year to every two years for producers with no record of non-compliance after three consecutive controls.
  • Reinforce the rules on precautionary measures to avoid accidental contamination by pesticides, giving consumers confidence that no pesticides have been used in the production of organic foods.

Following the European Parliament’s first reading, the proposed regulations will come into force on 1 January 2021, repealing Council Regulation (EC) 834/3007.

Please see here for more information on the new proposals.

On November 16, 2017, the Food and Drug Administration (FDA or the agency) issued a federal register notice soliciting comments on its Draft Guidance for Industry, “Best Practices for Convening a GRAS Panel.”

The Draft Guidance is intended for persons responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (FFDCA) when that person convenes a panel of experts (GRAS panel) to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human or animal food.

Click here to read more.

The UK tax authority HM Revenue and Customs (HMRC) has published draft Regulations setting out further details on the new UK ‘Soft Drinks Industry Levy’, which will apply from 6 April 2018.

The new levy applies to all soft drinks packaged in or imported to the UK that contain added sugar and at least 5 grams of sugar in total (both naturally occurring and added sugar) per 100ml of prepared drink (“chargeable drinks”). A levy of 18p per liter will apply, rising to 24p per liter for chargeable drinks containing 8 grams or more of sugar per 100ml.

Click here to read more. 

The U.S. Food and Drug Administration (“FDA”) recently issued a guidance document entitled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for
Human Food and Animal Food: Guidance for Industry.” This guidance is directed toward participants in “co-manufacturing” agreements in which a brand owner arranges for a second party
(the “co-manufacturer”) to manufacture food on its behalf and, as explained below, will affect contracts between brand owners and co-manufacturers, and brand owners and suppliers.

Click here to read more.

The UK Food Standards Agency (FSA) is consulting on its proposals to amend the Feed Law Code of Practice and Practice Guidance. The Code and Guidance have to be taken into account by local authorities when enforcing feed law requirements in England (there are separate documents for Wales, Scotland and Northern Ireland).

The FSA is developing an innovative “whole system strategy” to feed law control and enforcement. The proposed amendments to the Code and Guidance aim to improve consistency of enforcement and reduce the regulatory burden for feed businesses, while maintaining a high level of public and animal protection.

Click here to read more.


FDA is continuing to release resources intended to assist industry with implementation of the FDA Food Safety Modernization Act (FSMA). This post discusses four such documents that were released recently. First, FDA released Draft Guidance explaining the meaning of the phrase “solely engaged,” which is used in the regulations to establish several exemptions from the Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) rules. Second, FDA finalized its Guidance on current Good Manufacturing Practice (cGMP) requirements for animal food. Third, FDA developed a training program for carriers who are subject to the Sanitary Food Transportation rule. Finally, FDA released a new web page that lists compliance dates for rules that form the foundation of FSMA.

Read more.

The European Commission has published a draft implementing Regulation setting out the proposed official EU list of authorized novel foods.

A ‘novel food’ is a food or ingredient that has not been consumed to a significant degree in the EU prior to 15 May 1997. These include products traditionally eaten outside the EU prior to this date, such as chia seeds, argan oil and noni fruit juice, as well as foods produced using innovative processes, such as UV-treated mushrooms.

Currently, food manufacturers looking to use a novel food or ingredient in their products have to obtain prior authorisation from the first country in the EU in which the food/ingredient will be marketed. That authorization applies across the EU but is personal to the applicant, so other companies wishing to use the same food/ingredient have to apply for a separate authorization.

Click here to read more. 

This post originally appeared on Hogan Lovells Focus on Regulation.

Initial responses to the European Commission’s public consultation on how to make the EU food supply chain fairer suggest that, bar retailers, the majority of significant stakeholders (including Member States, farmer groups, agricultural organizations and NGOs) are in favor of action at EU level to increase fairness and balance in the food supply chain.

The EU-wide consultation has so far received record numbers of contributions. It was prompted by concerns that differences in bargaining power between farmers and SMEs and their economically stronger commercial partners has resulted in unfairness and unequal distribution of value across the chain.

The consultation follows the Agricultural Markets Task Force, set up by Commissioner Hogan last January, and seeks input on the necessity and expediency of measures to address the current imbalance. Views are also sought on ways to improve market transparency across the food supply chain and the potential use of value sharing agreements, already used in sectors such as sugar, to ensure that bonuses and losses resulting from evolutions in market prices are shared.

The on-going consultation ends on 17 November 2017. The full consultation document is available here.

This post originally appeared on Hogan Lovells Focus on Regulation blog.

October 25 – 27
Hogan Lovells Office, Beijing, China

The new Preventive Controls for Human Food regulation issued by the U.S. Food and Drug Administration (FDA) under the FDA Food Safety Modernization Act (FSMA) is the most significant change to food regulation since the 1930s.  FDA has started conducting inspections for compliance with the rule, both domestically and internationally.

The rule requires that key food safety management activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls.”  This requirement typically applies even if a company is located outside of the U.S., so long as it manufactures food for U.S. consumption.

Hogan Lovells attorneys Maile Hermida (Partner) and Xin Tao (Associate), both Food Safety Preventive Controls Alliance (FSPCA) lead instructors for this regulation, will present the  training program developed by the FSPCA.  This is the “standardized curriculum” recognized by FDA.  Successfully completing this course is one way to meet the requirement to become “preventive controls qualified individual.”

For more information and to register, click here.

October 31, 2017
12:00pm-1:30pm ET

Listeria monocytogenes bacteria sickens an estimated 1,600 people each year and of those about 260 die. The dangers of Listeria foodborne illness impacting U.S. consumers are very real and the implications of an outbreak can be enormously costly to the food processing industry.

FDA is currently reviewing public comments to the “Draft Guidance to the Industry on Control of Listeria Monocytogenes” which was published in January 2017. The industry can expect final Guidance from FDA soon. The new Guidance coupled with the Preventive Controls for Human Food (PCHF) enforcement is already resulting in a much more targeted approach by FDA with focus on both industry and FDA environmental swabbing. Positive swabs for L. mono. or indicator organisms could trigger aggressive FDA enforcement action.

Join presenters representing FDA, attorneys from Hogan Lovells and an EAS Independent Consultant and internationally known research microbiologist for a webinar focusing on the challenges and new FDA regulatory requirements for the detection and elimination of L. mono. This will provide attendees with leading edge and cross-cutting information on regulatory expectations as well as control mechanisms for L. mono. With this information, the food processing industry can improve existing L. mono. control programs, ultimately benefiting the consuming public. This webinar shares the perspectives of the new FDA enforcement strategy (preventive) from FDA’s view, a microbiologist sharing the latest information about L. mono as well as food industry counsel’s view. It is a “must attend” event for anyone with responsibility for complying with FDA’s new enforcement approach.

What do we know today about the “new” dangers of Listeria? What key monitoring and corrective action measures should the industry pay attention to, adopt and implement and how can we turn today’s risk assessment results into a safer and proactive approach to Listeria control?

Click here for more information and to register.