Rigid regulations - the Food Safety Modernization Act and the EU circular economy

24 May 2016

Amendments to important global regulations and the introduction of new legislation are expected in 2016. Of particular significance are the Food Safety Modernization Act and changes to the EU circular economy, which have far-reaching implications for the industry.

The US Food and Drug Administration's (FDA) Food Safety Modernization Act (FSMA) was signed into law in January 2011, but is only recently that certain facets of the law have been implemented. For instance, FDA is now more equipped to protect public health by strengthening the food-safety system. FDA can focus on preventing problems rather than reacting to them. The act also provides FDA with new powers of enforcement, which aim to achieve higher rates of compliance with prevention and risk-based food-safety standards. The law also gives FDA important tools to apply the same safety standards of domestic foods to imported foods. It also directs FDA to build an integrated, national food-safety system in partnership with state and local authorities.

Building a new food-safety system based on prevention will take time, and FDA is implementing a process to get it completed. The US Congress has established specific dates for the legislation to be fully realised. Some of FDA's new powers will be granted quickly, such as its ability to order companies to recall food. But other powers will take longer to be exercised, as FDA is required to prepare and issue regulations and guidance documents. The annual funding that FDA receives affects how quickly FDA can effectively use this legislation. It is committed to an open process with opportunity for input from all stakeholders.

The following are among FDA's major new authorities and mandates:

  • FDA will demand comprehensive and scientific preventive controls across the food supply chain. Its mandate includes preventive controls for food facilities, such as having a preventive control plan, which evaluates hazards to food safety; specifies preventive steps and controls to minimise or prevent hazards; specifies how the facility will monitor controls to ensure efficiency; maintains routine records of monitoring; specifies what actions the facility will take to correct problems.
  • FDA must establish a scientific, minimum standard for the safe production and harvesting of fruit and vegetables. The standard must consider naturally occurring hazards, and those that may be introduced unintentionally or intentionally. It must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, and animals in the growing area and water.
  • FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of scientific mitigation strategies to prepare and protect the food supply chain at vulnerable points.
  • The FSMA has preventive control standards to improve food safety, but these only work when producers and processors are compliant. FDA will provide oversight, ensure compliance with requirements and respond effectively when problems emerge. The FSMA provides FDA with inspection and compliance capabilities, including inspection frequency, access to producers and processors' records that will be tested by accredited laboratories to ensure that all testing meets the high-quality standards.
  • FDA can recall products, suspend companies, enhance product tracing and demand that additional records are kept for high-risk foods.
  • FDA can demand assistance from federal and state governments to help enforce the act.

EU circular economy

On 2 December 2015, the European Commission implemented a plan for a new circular economy, which will be supported by European structural and investment funds: €650 million from Horizon 2020 (the EU funding programme for research and innovation), and €5.5 billion from the structural funds for waste management and investments at a national level.

The plan aims to lengthen product lifecycles through greater recycling and reuse, which will benefit the environment and the economy. The Commission states that the measures could achieve net savings of €600 billion or 8% of annual turnover for businesses in the EU, and it will reduce annual greenhouse gas emissions by 2-4%.

The proposed legislation has clear targets and provisions for the reduction and management of waste. It includes:

  • simplified definitions and harmonised calculation methods for recycling rates in the EU
  • economic incentives for better product design through producer-responsibility schemes
  • increased reuse and recycling targets for municipal waste to 60% by 2025 and 65% by 2030
  • gradual limitations of municipal landfill waste to 10% by 2030 and a ban on separately collected waste in landfills
  • increased reuse and recycling targets for all packaging waste to 65% by 2025 and 75% by 2030, with additional targets for specific packaging materials such as plastic, wood, glass, paper and cardboard
  • separate collection of biowaste, including biodegradable garden and park waste, and food and kitchen waste from households, restaurants, caterers and retail premises.

Estonia, Greece, Croatia, Latvia, Malta, Romania and Slovakia will be given the option of applying for extensions to meet recycling and landfill targets.

Raw materials and water

The Commission proposal's to reduce municipal waste in landfills to 10% by 2030, combined with the ban on separated landfill waste, suggest that the era of large-scale landfills is over. In addition, recycling targets will be legally binding and will be a challenge for some member states.

There is much to debate about the Commission's package, but the direction is right. There is a demand for better product design, more stringent rules on reuse and recycling, and less landfill waste.


With its publication in the Federal Register in 2012, the new hazard communication standard (HCS) from the Occupational Health and Safety Administration (OHSA) established its alignment with the globally harmonised system (GHS) of classification and labelling of chemicals in the US.

Among the steps listed for full compliance, the most important this year is that containers need to be correctly labelled.

Chemicals will arrive at a facility in containers that have GHS labels. If the labels are damaged, they will need to be replaced. A container holding a hazardous material must, at a minimum, have a label identifying the product and general information about the hazards associated with that material.

In all cases, employees must be fully informed about chemical hazards, although some information may be supplied through means other than labels.

OSHA states that a compliant-hazard-communication programme must provide labelling for workplace chemical containers; identify the person responsible for ensuring all containers are labelled; describe the system to be used for labelling workplace containers; describe alternatives to labelling workplace containers; label chemical containers shipped from a facility; describe the labelling system used for making GHS labels for shipments; and establish procedures for reviewing and updating labelling information.

Changes to the circular economy could result in net savings of €600 billion.

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