The increasing regulation of the food industry in Europe is an inevitable consequence of the EU’s policy of strengthening consumer confidence in food safety and harmonising laws and regulations to ensure the free movement of food and feed.
Reflecting these developments, this guide has been prepared by Freshfields Bruckhaus Deringer and JohnsonDiversey to update food business operators on the regulatory challenges they are likely to face in 2008. It also considers the way in which the new EU food law regime is now operating in practice.
The basis of the EU’s approach to food regulation is:
- the general framework law on food safety (Regulation (EC) 178/2002), which applies product recall and notification obligations;
- a comprehensive package of food hygiene measures, which will play an increasingly significant role in 2008; and
- the new nutrition and health claims regulation coming into force in 2007.
The impact of these measures on the changing landscape of EU food law is considered in this guide.
In addition, we give an overview of the following regulatory trends and developments, which we anticipate will play a major role in 2008:
- regulatory developments in food labelling (including, nutrition and origin labelling);
- variances in regulatory enforcement powers and sanctions throughout the EU;
- public awareness of, and concern about, sustainability issues, such as carbon footprints and food miles;
- action to address ‘obesity’; and
- regulation concerning the use of food improvement agents (food additives, food enzymes and food flavourings).
Food safety – notification and recall
Which new obligations will most affect me?
The general framework law has created new obligations for all businesses in the food chain, from primary producers to retailers.
All food business operators must:
- ensure the safety of food within their businesses at all times;
- not market food that is unsafe; and
- maintain effective tracing systems and records.
How has the definition of ‘unsafe’ food been applied?
Several high-profile cases in 2007 have emphasised that:
- under the new regime, food is ‘unsafe’ if it is considered to be injurious to health or unfit for human consumption;
- safety must be assessed by reference to conditions of use, information provided to the consumer and consumer vulnerability; and
- regulators adopt the precautionary principle as a basis for action. This has allowed intervention where decisions have to be made to protect health but scientific information concerning the risk is inconclusive or incomplete in some way.
Which changes have proved to be significant?
The broad definition of ‘unsafe’ food has, again, been extremely significant in 2007-08. The general framework law obliges food business operators to take reactive steps where they ‘have reason to believe’ that food for which they are responsible is unsafe. These steps include withdrawal, recall and notification to regulators.
These new obligations mean that it is now difficult for companies to characterise a recall as ‘voluntary’, which may have public relations as well as insurance implications.
Key questions when deciding whether to notify a food safety issue include:
- when will a food business operator have reason to believe its food is ‘unsafe’?;
- has the product been ‘placed on the market’?;
- has it left your ‘immediate control’?; and ?? how ‘immediate’ does notification have to be?
Frequently, there is also uncertainty regarding the nature and amount of information that must be notified. This is significant because a regulator who receives information that is incomplete but indicates some risk to public health may feel obliged, on the basis of the precautionary principle, to seek or to implement robust corrective action and to ensure that its counterparts across the EU are informed (through the RASFF network described below).
Increased use of RASFF
RASFF’s prominence increased significantly in 2007 because of the notification obligations under the new regime and the increasing exchange of information by regulators.
RASFF means that, in 2008, product crisis information is even more likely to spread rapidly across the EU and beyond countries where any withdrawal or recall action is taking place.
This has strategic implications for any business involved in a food-related product crisis and requires that a cautious media and consumer information strategy should extend beyond those countries that are subject to the corrective action.
At its most extreme, RASFF can result in the immediate exchange of data among not only all 27 EU Member States but also among the other national regulators that monitor the system (eg in the US, Canada, Japan and Australia).
The food hygiene package
The other major change in EU food law has been the implementation and development of the new food hygiene package.
What is the food hygiene package?
The package is a series of measures intended to create a single, transparent hygiene policy applicable throughout the food chain ‘from the farm to the fork’. Key provisions are set out below:
- The onus is clearly placed on food business operators to ensure that food reaching EU consumers is safe. This applies to all food business operators, including caterers, primary producers (farmers and growers), manufacturers, distributors and retailers.
- All food business operators, except primary producers, must have a HACCP system in place to identify critical points where food safety hazards arise. They must also implement and maintain permanent food safety management procedures to control hazards and regularly verify their usage.
- Effective record keeping is essential.
Is a formal HACCP procedure necessary for all food businesses?
- Events in 2007 have continued to emphasise that HACCP principles must be implemented with flexibility, particularly for small food businesses.
- In particular, discussions continue to take place as to the proposal, issued by the European Commission in 2007, to exempt certain food businesses from the requirement in article 5 of Regulation (EC) No 852/2004 to operate HACCPbased food safety procedures.
- This proposal builds on the recognition that a ‘HACCP-light’ approach may be adopted by smaller businesses, as further explained in the guidance described below. However, an EU better regulation proposal to allow specific exemptions for small food businesses of less than 10 employees has received significant opposition.
Does my business need to be registered?
- All food businesses must be registered before opening.
- Premises of certain types of businesses must be approved rather than registered, including those producing meat and meat products, eggs, milk, dairy products and fish products.
What training must I give my staff?
- Food handlers must receive adequate supervision, instruction and/or training in food hygiene to enable them to handle food safely.
- Those responsible for the development and maintenance of HACCP procedures must have sufficient knowledge and understanding of HACCP to ensure that the procedures are suitable.
Regulation on microbiological criteria for foodstuffs
Regulation (EC) No 2073/2005 (Regulation 2073) on microbiological criteria for foodstuffs has applied since 1 January 2006. It works alongside the elements of the food hygiene package.
It establishes microbiological criteria to be used in assessing the safety of foods, divided into:
- food safety criteria, applicable before the food has left the immediate control of the food business operator and throughout the shelf-life of the products;
- process hygiene criteria for the manufacturing and handling of certain raw materials and foodstuffs; and
- rules for sampling as well as preparing test samples.
Regulation 2073 provides criteria for a number of pathogens, including L. monocytogenes, Salmonella, E. coli and Enterobacter sakazaki. It was amended on 24 October 2007 regarding the use of liquid pepsin for the detection of Trichinella in meat.
Guidance on the food hygiene package
The EU has issued formal guidance documents to help food businesses understand the new legal requirements on the hygiene of foodstuffs, HACCP procedures and principles, and import requirements/new rules on official food controls.
Community and national guides to good practice
In addition, the food hygiene package encourages the development, dissemination and use of guides to good practice for food hygiene or for the application of HACCP principles. There are two types of guides.
- National guides – Member States are continuing to encourage their development and assess them to ensure that their contents are practicable, that they have been developed regarding the general principles of food hygiene of the Codex Alimentarius and that all interested parties have been consulted. National guides complying with these requirements are to be forwarded to the European Commission.
- Community guides – if a Member State or the European Commission considers that there is a need for uniformity, the Commission may develop Community guides on a particular issue.
Although such guides are not legally binding:
- they can be used on a voluntary basis as an aid to compliance with obligations; and
- where a feed or food business is using such a guide, the competent authorities should take it into account during enforcement activity.
The European Commission has also set up a register making the national guides available to Member States and food business operators.
To date, the available guides cover areas as diverse as beekeeping and HACCP systems for use in abattoirs and meat cutting plants.
Regulatory trends for 2008?
The EU continues to recognise that the labelling of foodstuffs is an issue that elicits strong views.
Previously, Commissioner Kyprianou has acknowledged that industry is concerned that there is too much legislation, much of which is inconsistent, while consumer and health organisations argue that more is needed. The European Commission has indicated that the reality is likely to lie somewhere between these two points of view.
This is an area that has been identified as being appropriate for reform regarding both simplification and better regulation. Therefore, the European Commission has also indicated that its strategic goal is to define an approach to labelling that will provide consumers with the necessary information to enable them to make safe, healthy and sustainable choices.
Mandatory nutrition labelling on packs?
Debate in the EU is likely to focus in 2008 on proposals from the European Commission for new regulation about nutrition and origin labelling on packs. Although the final form of the proposal is not yet known, Commissioner Kyprianou has indicated that all national and manufacturer schemes ‘will have to meet specific requirements and be accurate’.
In return, a number of Member State regulators have demanded that the European Commission now come forward with proposals that ‘will strengthen nutrition labelling as a channel for clear, consistent, evidence based information for consumers’. Key questions include the extent to which the European Commission will:
?? allow Member States to adopt or endorse national labelling schemes; and
?? prevent a Member State from blocking the sale of products bearing labelling recognised in a different Member State
Nutrition and health claims
The provision of consumer information is a key part of the EU’s regulatory strategy. As part of this approach, the Nutrition and Health Claims Regulation (the Regulation) came into force in 2007 and will play an increasingly important role in 2008.
- The Regulation governs the advertising, presentation and labelling of foods.
- In particular, it introduces specific criteria for the use of nutrition claims (eg ‘low fat’) and health claims (eg ‘strengthens the body’s defence system’). For example: –– a product claiming to be ‘high in fibre’ has to have at least 6g of fibre per 100g net weight; –– a ‘light’ or ‘reduced fat’ claim can only be made where the product contains at least 30 per cent less fat than a similar ‘full fat’ product; and –– a variety of ‘vague’ health claims, reference to and endorsement by medical practitioners, weight control or slimming claims will be prohibited.
- Certain claims need specific preauthorisation.
- Most controversially, and as a result of scientific advice from EFSA, the European Commission will, by 19 January 2009, fix nutrient profiles based, in particular, on the content of fat, saturates, sugar and salt in a product. The use of nutrition and health claims will be restricted on products deemed to contain excessive levels of a number of these constituents.
Products intended exclusively for consumption by children (other than infant formula products) are now to be considered as claims under article 14 of the Regulation according to guidance recently agreed by the EU.
Member States had until 31 January 2008 to submit health claims to the European Commission who, on the advice of EFSA, will decide if they can be listed. These claims will need to be accompanied by references to the relevant scientific justification and conditions of use. Lists submitted by the Member States will be adopted and included in the Community List by 31 January 2010.
Regulatory enforcement powers and sanctions
One area increasingly likely to receive attention in 2008 is the variances in regulatory enforcement powers and sanctions throughout the EU, which has led to the phenomenon of ‘disharmonised harmony’ in the enforcement of the EU food law regime.
Regulators’ investigative powers are determined at a Member State level and vary considerably across the EU. By way of example, in the UK, the powers include the right to enter and inspect premises, to seize and detain records without notice during ‘dawn raids’ and to conduct interviews with employees under caution. It will usually be an offence for a person to obstruct a regulator in the exercise of these powers and employees may have a positive obligation to assist regulators with their investigations.
A key distinguishing feature throughout the 27 Member States is the extent to which individuals can face sanctions as a result of non-compliance with EU food safety law.
The primary obligations under food safety legislation in the EU fall on food business operators, namely businesses involved in processing, manufacturing, handling or distributing food, including retailers and caterers. But, in certain Member States (including the UK), individual directors and officers of a company (including those purporting to act in such a capacity) may also be personally liable if an offence is committed with their consent or connivance or is attributable to their neglect.
It is therefore critical that food business operators act in a way that maximises their ability to rely on applicable ‘due diligence’ defences wherever possible.
Similarly, sanctions for non-compliance are not harmonised across the EU. For example, failing to initiate withdrawal or recall procedures is punishable:
- in the UK, by a potentially unlimited fine and/or imprisonment for up to two years; and
- in France, by a maximum fine of €75,000 and/or imprisonment for a term not exceeding four years.
Sustainability – carbon footprints and food miles
Increased public awareness of, and concern about, sustainability issues, such as carbon footprints and food miles, is having a dramatic impact on the food industry.
A number of major food companies have recently signed up to schemes to measure the amount of carbon emitted during food production.
This reflects a global trend and could form the basis for other such schemes worldwide or, ultimately, an international scheme. In the meantime, the food industry is left to consider whether lessons learned from the use of competing food safety standards and other labelling schemes suggest it should:
- push for a harmonised template for carbon labelling (especially for air freighted food); or
- adopt company-specific eco-labelling strategies (at the risk of increasing consumer confusion with inconsistent food labelling).
Carbon footprinting highlights the need to analyse product supply chains rigorously before attaching a carbon label to a food product and this will be costly. However, such labelling will create brand promotion and competitive opportunities in 2008.
Food miles may be only one small part of a product’s carbon footprint, but they are under increasing consumer and regulatory scrutiny. The food miles debate is not just about the environment but also the use of sustainable raw materials, supporting local economies and ethical supply chains.
Efforts to ensure sustainability continue to be industry and consumer driven, but the European Commission is discussing whether it should have a role in ‘guiding’ consumers and providing a framework for clarifying what falls under specific ethical claims (with the intention of bringing consistency and clarity for consumers).
In the US, obesity-related litigation has progressed at an alarming speed. Many of the claims have been funded by a plaintiffs’ bar that has made enormous sums in asbestos and tobacco litigation and which is seeking to adapt its earlier tactics to a new set of defendants. By contrast, in the EU, the tendency continues to be that ‘obesity’ issues are regulated rather than litigated.
For example, the EU’s efforts to regulate health and nutrition claims are clearly intended to help consumers navigate towards ‘healthier’ products.
Commissioner Kyprianou has said: ‘The rise of obesity makes improving the diets and physical activity levels of Europeans a top public health priority for the EU in the years ahead. If we don’t act, today’s overweight children will be tomorrow’s heart attack victims.’
Following this statement, the EU adopted in 2007 a White Paper setting out a wide range of proposals on how the EU can tackle nutrition and ‘obesity’ related health issues.
The White Paper emphasises the importance of enabling consumers to make informed choices and calls upon the food industry to work on reformulating recipes, in particular to reduce levels of salt and fats.
The European Commission will monitor the progress and performance of all actors it considers relevant, with a first report due in 2010. It is also expected to collaborate with the World Health Organization to improve surveillance of nutrition and physical activity actions and health status in the EU.
One key issue to be monitored in 2008 is the extent to which the EU will seek to legislate in this area beyond the scope afforded to the Community by the EC Treaty.
Food improvement agents
One of the last acts of 2007 for the European Council was to reach an overall political agreement on a legislative package on food improvement agents (in other words, food additives, food enzymes and food flavourings).
The common position will now be forwarded to the European Parliament for a second reading, in accordance with the co-decision procedure.
The package on food improvement agents aims at harmonising across the board, in accordance with the ‘farm to fork’ concept, the evaluation procedure for authorising food improvement agents.
The aims of the four proposed regulations are as follows:
- A common authorisation procedure for food improvement agents, which establishes a uniform, centralised, efficient and transparent process based on a risk assessment carried out by EFSA.
- That a common list of food additives be established by the committee procedure instead of the co-decision procedure, as provided for in the existing Directive 89/107/EEC. The relevant legislative and technical review covers a dozen types of additives, including antioxidants, preservatives, colours and sweeteners. Additionally, this text imposes the obligation for a request for authorisation concerning additives consisting of genetically modified organisms, in accordance with Regulation (EC) No 1829/2003.
- Introducing for the first time a harmonised EU procedure for the authorisation of food enzymes.
- A new proposal that stipulates the fields of application of EU legislation governing flavourings.