Cleaning up biocides legislation

As the European Commission reviews its biocide legislation and sets Maximum Residue Levels for dual use biocides, Kaarin Goodburn MBE of the Chilled Food Association explains why biocides are vital to assure food hygiene and safety.

Biocides, and specifically biocidally active compounds (biocidal ‘actives’), are chemical substances (or microorganisms) intended to destroy, deter, render harmless or exert a controlling effect on any harmful organism by chemical or biological means.  Examples include disinfectants, preservatives, pesticides, herbicides, fungicides, insecticides and antiseptics.

Biocides play a vital role in assuring the hygiene and safety of food and drink and the food production environment in the field, in food production, in foodservice settings and at home. They may be applied or be present as surface coatings (e.g. metallic ions). Biocidal products targeting bacteria include:

• Disinfectants used to reduce the number of microorganisms. They are classified as low, medium or high-level disinfectants, depending on how many types of microorganisms they kill. Highlevel disinfectants are called chemical sterilants.
• Preservatives added to products, such as food, animal feeds or household products, for the primary purpose of inhibiting the growth of microorganisms. A number of groups of formulated products are used to control hygiene in the food chain. The active chemicals used in detergents and sanitisers are surfactants and biocidal actives.  Other components, such as cationic surfactants, quaternary ammonium compounds and fragrances, also have biocidal activity and can therefore perform a dual role in some formulations.

Food businesses’ safety and hygiene legal obligations

Food Business Operators (FBOs) must comply with the EC General Food Law (178/2002 ^[1]) and assure food safety and hygiene. Ensuring cleanliness of the food production environment is a fundamental requirement of food hygiene legislation and a Critical Control Point (CCP). Chapter V of the EC General Food Hygiene Regulation 852/2004 ^[2]  stipulates that: ‘All articles, fittings and equipment with which food comes into contact are to: (a) be effectively cleaned and, where necessary, disinfected. Cleaning and disinfection are to take place at a frequency sufficient to avoid any risk of contamination…’

Establishing, validating and monitoring the efficacy of cleaning and disinfection is a CCP and therefore is covered by the requirements on FBOs to use HACCP principles (Article 5, 852/2004).

In addition, water must meet the minimum requirements laid down in the so-called Water Quality Directive 98/83/EC [3], i.e. ‘all water used in any food-production undertaking for the manufacture, processing, preservation or marketing of products or substances intended for human consumption unless the competent national authorities are satisfied that the quality of the water cannot affect the wholesomeness of the foodstuff in its finished form.’

The Pennington Reports (1997 and 2009) into two fatal outbreaks of E.coli 0157 highlighted the importance of providing clear information on cleaning and disinfection to food businesses.

Why we need biocides

Cleaning and disinfection is carried out primarily to control pathogens. The Pennington Reports (1997 and 2009) into two fatal outbreaks of E.coli 0157 highlighted the importance of providing clear information on cleaning and disinfection to food businesses:

• At the Fatal Accident Enquiry of the Lanarkshire incident, Sheriff Cox drew attention to the fact that the butcher involved thought that a biodegradable detergent was in fact a bactericide and this ignorance led him to contaminate the whole of his premises and many cooked products with E.coli O157. (1997 report)
• The FSA should remove the confusion that exists among food business operators about what solution(s) should be used to prevent cross-contamination from surfaces and equipment. [Recommendation 6, 2009 report] Although these two fatal outbreaks of E coli O157 were the foci of the Pennington Reports, Listeria monocytogenes causes the greatest number of deaths from foodborne disease in the UK, EU and USA.

Cleaning and disinfection regimes for L. monocytogenes will also control other foodborne vegetative pathogens. L. monocytogenes is particularly challenging because, when it persists in food processing environments, it is often in the form of a biofilm. These biofilms are difficult to eradicate as they protect the organism from environmental stresses. Although the majority of L. monocytogenes are attached to the biofilm, the cells in the upper layer can move around and have been observed to transfer from the biofilms onto food on contact ^[4].

Routine cleaning and sanitation can be effective in preventing the establishment of biofilms. The choice of biocide is determined by a number of factors including the nature of the surface to be treated. Biocides efficacy against various pathogens varies, particularly regarding the efficacy of the initial cleaning step to remove gross debris and protein (Table 1). 

Table 1 - Efficacy of sanitisers v. L. monocytogenes on poorly and properly cleaned surfaces or suspensions

Regulation of biocides

Biocidal actives are primarily regulated through the EU Biocidal Products Regulation (BPR) 528/2012 ^[5]. Those that are approved for food and feed use are referred to as Product Type 4 (PT4) biocidal actives. It is notable that food hygiene legislation is not referred to in this EC diagram (Figure 1). PT4 biocides can be used for direct contact with food in the following applications:

• disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed for humans and animals, and
• to impregnate materials which may enter into contact with food.

Figure1 - Relationships between EU food legislation and the Biocidal Products Regulation

Since biocides are used to assure the safety of drinking (mains) water they can carry over into foods with which they come into contact.  Such water used in contact with foodstuffs or food contact equipment is an indirect addition to food and therefore not covered by PT4 but by other categories. Biocides that are or have ever been used as pesticides are also regulated by EU plant protection products (PPP) legislation 396/2005 ^[6]  which sets Maximum Residue Levels (MRLs) for pesticides in or on food and feed. In the absence of a specific MRL, the default MRL in 396/2005 is 0.01 mg/kg. Other MRLs can be set on the basis of evidence, considering PPP residue aspects only and not hygiene aspects.

MRLs are not safety levels, but relate to best agricultural practice in the use of pesticides. Furthermore, MRLs are set without consideration of dual use materials’ usage to assure hygiene and food safety. The assumption is that their presence only arises from use of the material as a PPP.

Clearly, the positive  benefits of  responsible use of biocides to prevent micro- biological contamination needs to be balanced with the need to set practicable levels.

Clearly, the positive benefits of responsible use of biocides to prevent microbiological contamination needs to be balanced with the need to set practicable levels. The regulatory relationship between biocides, pesticides and disinfectants is shown in Figure 2.

Figure 2 - General, relationship between biocides, pesticides and disinfectants, their usage and regulatory bodies

Quaternary ammonium compounds (quats)

Quats are highly effective against Gram positive organisms, such as Listeria monocytogenes. Quat compounds benzalkonium chloride (BAC) and didecyldimethylammonium chloride (DDAC) were found in 2012 to frequently be present on sampled produce at >0.01ppm, which was the applicable MRL at that time. A temporary MRL of 0.5 ppm was subsequently introduced to facilitate continuing trade and allow time for adaptation of practices to minimise levels. Following this, the MRL was reduced to 0.1 ppm on 12 August 2015. Despite this, there is no legislated reason to cease usage, e.g. on non-food contact surfaces.

Chlorates

Chlorine has been used worldwide to assure the safety of drinking water for more than a century. However, chlorates can be formed from water chlorination and also from hypochlorite used in washwater and on food contact surfaces. Since use of chlorate as a pesticide and direct addition to food was banned EU-wide on 10 May 2010, PPP legislation applies to food and feed where water containing chlorates is used.  

The EC default MRL of 0.01ppm was agreed by EU Member States to be impracticable so MRLs are to be set under 396/2005. No MRLs have been set for chlorate in drinking water in the EU. The World Health Organization, considering both health protection benefits of water chlorination and general disinfection, established a voluntary guideline level for chlorate in drinking water of 0.7 mg/l. 

According to the UK’s Drinking Water Inspectorate, typically water companies keep the level of residual disinfectant in the form of free or combined chlorine to 0.5 mg/l or less, but chlorate can be as high as 1ppm. This is substantially higher than any of the MRLs currently being considered for foods, which are to be consulted on. This is an issue since chlorate is taken up from water by crops’ foliage in particular, which brings into potential conflict the need to irrigate ready to eat crops using clean water to help assure safety and hygiene. 

Regulatory conflict?

Regulatory conflict exists in a number of circumstances:

• Since the presence of biocides in water is not regulated through PPP legislation, carry over of water hygiene biocides into foodstuffs (e.g. through irrigation, washing, use of water as an ingredient) can lead to MRL breaches.
• The use of dual-use biocides purely for hygiene purposes is not recognised, their presence being assumed to be owing to inappropriate use as pesticides. This results in the potential for food hygiene and safety to be compromised unless a balance is struck between using biocides responsibly in agricultural practice whilst protecting human health from a food hygiene perspective.
• Biocidal actives found through the BPR assessment system not to require an MRL would still require a default MRL of 0.01ppm under 396/2005.
• There will be a mixture of BPRapproved and non-approved biocides on the market in the next 3-5 years, which may distort the market.

What does this mean for proposed MRLs for commodities? What about composite products?

In the UK, the Health & Safety Executive (HSE) has taken the stance that MRLs specified in Annex 1 of 396/2005 apply not only to the commodities listed, but also to derivatives thereof and composite products (e.g. cakes, sandwiches, ready meals, desserts). However, this position is not reflected as standard practice throughout the rest of the EU.

What is the desired end point?

The food and biocides industry at UK and EU level is seeking:

1. A clear, rational basis for regulation that will:

• Protect public health by recognising non-PPP use of biocides
• Include full risk assessment of impacts on hygiene including water
• Exclude non-pesticide use of materials from the scope of 396/2005.

2. Clear enforcement guidance and rationale delivering a common Europe-wide interpretation of 396/2005, such that application of MRLs applies to only those commodities listed and not composite foods. 

What is the industry doing?

In the UK the Chilled Food Association is leading the Food & Biocides Industry Group (FBIG), which currently comprises 15 trade and professional organisations from food to fork in both retail and foodservice. In addition to producing a position 
statement ^[7], FBIG has issued freely downloadable guidance ^[8] on Biocides in Cleaning & Disinfection which is available from its members’ websites.

The FBIG guidance addresses:

• Management of cleaning and disinfection
• Principle categories of biocides used in the food industry, their advantages and disadvantages
• Cleaning and disinfection in practice
• How to minimise chlorates
• Risk assessment of biocides remaining on contact surfaces
• Listing of PT4 biocides • CFA’s Produce Washing Protocol
• Hygiene planning and assessment recording templates.

An EU-level biocides and food industry group is actively lobbying the European Commission to achieve the desired end-points including practicable and rational chlorate MRLs. The European industry group comprises biocide industry organisations CeficEBPF and AISE, and for the food industry, FoodDrinkEurope and the European Chilled Food Federation (ECFF). The group’s joint position paper on setting Maximum Levels for biocides in food is included in the FBIG guidance.

FBOs should ensure that they are adhering to the specified usage instructions for biocides

What should individual businesses be doing?

FBOs should ensure that they are adhering to the specified usage instructions for biocides and if in doubt regarding suitability for the specific use should contact their biocide suppliers.

Kaarin Goodburn MBE CSci FIFST is Director of the Chilled Food Association (CFA).  The CFA represents chilled prepared food manufacturers supplying the UK market. P O Box 6434, Kettering NN15 5XT, UK   Tel: +44 1536 514365   Email: cfa@chilledfood.org  Web: www.chilledfood.org

References

1. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32002R0178&from=EN
2. Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs. http://eur-lex.europa.eu/legal-content/AUTO/?uri=CELEX:32004R0852&qid=14...
3. Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. http:// eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0083&from=EN
4. Truelstrup, H.L. et al (2011). Desiccation of adhering and biofilm Listeria monocytogenes on stainless steel: survival and transfer to salmon products. Int J Fd Micro, 146, 88-93.
5. Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. http://eur-lex.europa.eu/legal-content/AUTO/?uri=CELEX:32 012R0528&qid=1469441672513&rid=1
6. Regulation (EC) No 396/2005 of the European Parliament And of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/ EEC. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32005R0396&...
7. FBIG Position Statement on Use of Biocides to Assure Food Hygiene and Safety.  http://www.chilledfood.org/wpcontent/uploads/2016/02/Biocides-UK-industr...
8. Biocides in Cleaning and Disinfection. http://www.chilledfood.org/wp-content/uploads/2016/05/CFA-043-16-Biocide...