Review of the regulatory management of food allergens

3.2 Precautionary labelling

3.2.1 Allergen cross contact

The purpose of precautionary labelling is generally to alert food allergic consumers to the possible presence of an allergen in the product where the allergen was not intentionally added but may have occurred due to cross contact. The cross contact may result in significant or only trace amounts of an allergenic substance that are sporadically introduced to the food products. Cross contact may occur anywhere along the supply chain and/or the production process including the growing and harvesting of crops, storage and transport of food, or via processing equipment at the manufacturing plant.

Whilst the current allergen declaration requirements in the Code do not prohibit the use of precautionary statements such as ‘may contain...’, the Code does not include specific provisions for food labelling in relation to cross contact allergens. To provide additional information to consumers on the possible presence of allergens due to cross-contact food manufacturers started using a variety of precautionary statements such as:

‘may contain…’

‘may contain traces of…’

‘made in the same premises as products containing…’

‘made on the same equipment as products containing...’
Allergic consumers and public health professionals have criticised the food industry for inconsistent and an apparent ‘blanket approach’ to precautionary allergen labelling. Data from consumer surveys indicate that there are a significant percentage of allergic consumers who do not always heed the precautionary statement and therefore may be taking risks by choosing to consume these products.

3.2.2 International regulations

FSANZ is aware that other food regulators are also considering the issue of precautionary labelling.

The Japanese Ministry of Health, Labour and Welfare is the only known agency that, under its Ministerial Ordinance on the Food Sanitation Law Enforcement Regulations, currently forbids the use of ‘may contain’ labelling. However, statements such as ‘made on the same equipment as products containing...’ are deemed acceptable for use.
Precautionary labelling is not currently regulated in the EU and the USA. The Canadian government (Health Canada) is in the process of reviewing its policy on the use of precautionary statements for food allergens. The policy review will focus on identifying specific statements that industry will be allowed to use on labels, as well as conditions that must be met before they are allowed to use these statements.
In August 2008, the USFDA held a public hearing on the use of precautionary labelling of allergens in foods, with the aim of developing a long-term strategy to support manufacturers in using precautionary labelling that is truthful and not misleading, conveys a clear and uniform message, and adequately informs food-allergic consumers and their caregivers. The public hearing was a first step in collecting information on how manufacturers are currently using precautionary labelling, how consumers interpret the different precautionary statements and their perceived usefulness, and what wording is likely to be most effective in communicating to consumers the likelihood that an allergen may be present in the food. The outcomes of the public hearing will support the USFDA in its consideration of various government and industry approaches to develop its precautionary labelling guidelines.

There is no information available in relation to the timelines of the USFDA’s development of precautionary labelling guidelines.

3.2.3 Outcome of stakeholder consultation

Responses to the issues paper released by FSANZ in March 2008 for targeted stakeholder consultation indicated that precautionary labelling and, in particular, the plethora of various statements currently being used, was an area of concern. Consumers may not be able to evaluate the actual risk through these statements alone, and could misinterpret the potential harm that the food in question may cause.

There was support for voluntary, industry based initiatives in this area (see section on Food industry initiatives below), and the comment was made that FSANZ could participate and support the further development of these industry based strategies rather than seek to achieve similar outcomes though mandatory regulation.

3.2.4 Food industry initiatives

The industry guide specifically addresses cross contact allergens through the Voluntary Incidental Trace Allergen Labelling (VITAL) system. VITAL, launched in June 2007, aims to provide a risk-based approach for food manufacturers to use in assessing the impact of cross contact allergens and to guide the use of appropriate allergen advisory labelling (AFGC, 2007). The Allergen Bureau continues to further develop VITAL and provide training to food manufacturers on its application.
VITAL uses a decision tree and action level grid, which identifies three action levels, to determine the need for precautionary labelling. The VITAL action levels are:

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  Action Level 1 – Green Zone – precautionary labelling is not required for the allergen under evaluation.
  

• 
  Action Level 2 – Yellow Zone – precautionary labelling is required for the allergen under evaluation, using the recommended precautionary statement ‘may be present: xxx’ where ‘xxx’ lists each of the cross contact allergens present at VITAL action level 2. The precautionary statement ‘may be present’ is to be used only in conjunction with VITAL.
  

• 
  Action Level 3 – Red Zone – significant levels of the allergen are likely to be present in the food; therefore, listing the allergen in the ingredient list is required.
  

The VITAL Action Levels are based on the principle that there is a lower limit of allergenic food which triggers an allergic reaction. The VITAL levels use currently available information, from the published literature, on the lowest observed adverse effect levels (LOAELS). Research is continuing, mainly in Europe, to improve the quality and quantity of data in this area of clinical testing for the purpose of establishing threshold levels for allergenic foods. The VITAL system is to be periodically reviewed to ensure it remains up to date, with the first review currently underway.

The Allergen Bureau has also developed a product information form (PIF) for use by companies to collect information about the origins of ingredients, including their composition and the presence of allergens, amongst other information. The allergen information contained in the PIF can be incorporated into the VITAL decision tree to assist in determining the appropriate VITAL action level.
The Allergen Bureau provides training on the use of the VITAL system and PIF to the food industry. FSANZ, through its participation in meetings and conferences, remains aware of industry efforts and progress in this area. The New Zealand Food and Grocery Council (NZFGC) endorses industry initiatives implemented by the AFGC in Australia regarding the management of allergens in the food processing environment, and makes the ‘Food industry guide to allergen management and labelling’ (AFGC, 2007) available via its website.

3.2.5 Consumer research

Consumer research (2003 and 2008) collected data on consumers’ views and behaviours towards food allergen labelling requirements, including the use of precautionary labelling statements. Both surveys indicated that the extensive use of precautionary labelling presents a difficulty to allergic consumers and their carers. A main concern was that precautionary statements were overused, possibly by manufacturers ’when in doubt’. The overuse of precautionary statements may cause allergic consumers to unnecessarily restrict their food choices, and undermines the impact of the statement. Studies have shown that food allergic consumers may ignore product precautionary statements as a result of an increase in use of such statements (Hefle et al., 2007; Lemon-Mule et al.’ 2007). A further concern was that due to the ambiguous wording of many precautionary statements such as ‘may contain...’, such statements carry with them a level of uncertainty such that consumers cannot be assured one way or the other about the presence of the allergen.

The most recent consumer research (FSANZ, 2009) also indicated that consumer understanding and behaviour in response to precautionary labelling varied widely depending on the statement. Questionnaire respondents were presented with the following precautionary statements:
'may contain traces of...'

'made in the same premises as...'

'made on the same equipment as...'

'may be present'

The final statement 'may be present' was not included in the original benchmark survey questionnaire, but was added to the follow-on survey questionnaire following its introduction via the industry based initiative VITAL.

For all four statements, between one third and one half of respondents considered them to be ‘not very useful’. These results represented an improvement since 2003, where over one half of respondents considered the first two statements to be ‘not very useful’. In both surveys, the statement ‘made on the same equipment as...’ was considered the most useful, with 46% and 34% of respondents considering this statement to be very useful in 2003 and 2008, respectively.

In terms of avoidance, in both surveys, most respondents would either always avoid or sometimes avoid products featuring these statements. The likelihood of always avoiding the product varied somewhat, depending on the statement type, with 66% and 47% of respondents always avoiding a product labelled with ‘made on the same equipment as...’ according to the 2003 and 2008 surveys, respectively.
The highest level of avoidance occurred in response to the precautionary statement ‘may be present’ which is recommended in the AFGC Guideline (AFGC, 2007). Sixty percent of respondents reported always avoiding a product labelled with 'may be present'.

The statement ‘may be present’ is recommended in the AFGC Guideline in conjunction with the application of the VITAL system.

This is an interesting result given the recent introduction of VITAL and this particular statement. This result appears to be a spontaneous reaction by consumers to the wording of the statement and may not relate to the level of consumer awareness of the VITAL system that underpins the use of the ‘may be present’ statement. The survey did not provide respondents with any information regarding the VITAL system, nor was any prior knowledge and awareness of this system among respondents assumed. However, this is a promising start as it indicates that the choice of wording of the statement itself appears to have an instinctive effect on consumers compelling them to avoid the product.
In relation to the various precautionary statements, it appears that consumers are assigning differential levels of risk to differently worded precautionary statements, in the absence of further information. The statement ‘made on the same equipment as...’ was considered the most useful, possibly because it is less ambiguous than the other statements evaluated, and it describes an actual processing step where cross contact with allergens may occur. However, allergic consumers are less likely to avoid products with this statement than products with ‘may be present’ statement.

3.2.6 Label monitoring surveys

FSANZ label monitoring surveys

Label monitoring surveys have been commissioned by FSANZ since 2002 to assess how food manufacturers are managing key labelling requirements set out in the Code. Correct labelling is a key objective of the Food Standards Australia New Zealand Act 1991 to ensure consumers have adequate information to help them make informed choices.

The results of these surveys have assisted FSANZ in assessing the effectiveness of current labelling regulatory measures and also provide evidence to inform future decisions on labelling laws, as part of the standards development process.

Food label monitoring surveys undertaken by FSANZ in 2002/2003 (Phase 1) and 2005/2006 (Phase 2) examined the use of precautionary labelling statements as part of allergen labelling requirements.

A plethora of statements was reported, with the most common statement being ‘may contain traces of...’. Other commonly used statements included ‘may contain X traces’, ‘this product may contain traces of...’, ‘may contain...’, and ‘manufactured on equipment that also produces products containing...’. Analysis of the most recent (Phase 2, 2005/2006) indicates that precautionary labelling statements were present on 28% of labels assessed.

The table below provides a breakdown of the different wordings used for precautionary statements.

Percentage of labels	Wording of Precautionary Statements
59%	‘ May Contain Traces’
7%	‘May Contain...’ (Note the word traces is not used)
29%	‘Made/manufactured in equipment/factory/facility that also packs/comes into contact with...’
5%	Other

It should be noted that the Phase 2 survey was undertaken in 2005-2006, prior to the launch of the food industry guidance on precautionary labelling.

FSANZ allergen label monitoring survey
The allergen label monitoring survey undertaken in 2009 examined the use of precautionary labelling statements against the labelling recommendations set out in the industry guide. Precautionary labelling statements were present in 48% of labels (88 of 182 labels) collected and covered all of the major food allergens, noting that in this survey, labels were selected on the basis of there being either an allergen declared in the ingredient list; an allergen summary statement; or a precautionary statement.
Thirty-five different precautionary statements were recorded, representing variations of the statements given in the table below.

Percentage of labels	Wording of Precautionary Statements
41%	‘may contain traces of...’
15%	‘may be present’
13%	‘made/manufactured on equipment/machinery that also processes...’
9%	‘made in a facility/plant that also processes products with/containing...’
9%	‘may contain...’
13%	other

Note that the industry recommended wording ‘may be present’ was used on 15% of labels with precautionary statements.

Allergen Bureau labelling review survey 2009
The labelling review survey undertaken by the Allergen Bureau in 2009 examined allergen related information on 340 packaged food products. Results were similar to those obtained in the FSANZ mini allergen label monitoring survey also conducted in 2009. In this survey, precautionary labelling statements were present on 47% of sampled products. Thirty-four different precautionary statements were recorded, with the most frequently used precautionary statements shown in the table below.

Percentage of labels	Wording of Precautionary Statements
38%	‘may contain traces of...’
7%	‘may be present’
22%	‘manufactured/made on equipment/production line that also processes...’
6%	‘may contain...’
1%	‘contains traces of’
26%	other

The industry recommended precautionary statement ‘may be present’ was used on 7% of labels with precautionary statements.

In summary, the results of label monitoring surveys examining the use of precautionary labelling statements indicate that the use of a broad range of statements continues. At this time, uptake of the recommended wording ‘may be present’, appears to be limited. This is understandable as the management of allergens by food manufacturers to reduce the need for precautionary labelling is a complex task and the industry initiative is still at an early stage of implementation.
The VITAL system involves a series of technical steps including assessment of the likely sources of allergens from raw materials and the processing environment, evaluation of the amount of allergen present, determining the ability to reduce the allergenic material from all contributing sources as well as ongoing monitoring and verification. The Allergen Bureau is committed to improving precautionary labelling practices across the industry. The Allergen Bureau has made recommendations for future work to increase the number of food manufacturers following the industry guide.
While this voluntary system is underway in Australia and New Zealand, there remains a gap with regards to imported foods, where the same or equivalent measures are not adopted by the country of export.

3.3.1 Conclusions

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  The use of clear terminology and easily understood names for ingredients assists allergic consumers in recognising products they need to avoid.
  

• 
  Despite improvement in consumers’ ability to recognise ingredients of concern where the source allergen is not declared by name, a percentage of allergic consumers fail to do so. However, data from the label monitoring surveys indicate that declaration of the source of allergenic ingredients is widely practiced by the food industry on a voluntary basis, as recommended by the peak industry body the AFGC and endorsed by the NZFGC.
  

• 
  In general, regulatory requirements and additional voluntary declarations provide adequate information to allergic consumers to assist them in identifying ingredients of concern. Based on the consumer survey of 2009, 5% of respondents reported they have suffered an allergic reaction due to unlabelled or incorrectly labelled food.
  

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  Allergic consumers and their carers have an expectation that precautionary labelling should be truthful and not misleading, and provide accurate, clear and consistent information about the potential presence of food allergens.
  

FSANZ recognises that the potential for cross contact allergens is inherent to the food production and processing environment. A desirable outcome is to improve the precautionary labelling such that it maximises food choices for allergic consumers without compromising safety.

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  Precautionary labelling is recognised internationally as a difficult area to regulate. The science needed to answer relevant questions and to underpin decisions, such as allergen thresholds and the reliability of detection methods, is not available or is incomplete. Research is continuing to improve the evidence base and to establish robust risk assessment methodology in this area.
  

• 
  The food industry is committed to improving the management of food allergens along the supply chain and in the manufacturing environment. A voluntary approach to precautionary labelling is endorsed by industry peak bodies in Australia and New Zealand.
  

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  The initiative by the food industry to improve the management of cross contact allergens and the use of precautionary labelling is currently underway. FSANZ recognises the commitment by the food industry to improving the use of precautionary labelling through the development and adoption of strategies to minimise cross contact. The adoption and consistent application of these tools has the potential to address the issue of precautionary labelling without the requirement for mandatory regulation in this area.
  

• 
  The effectiveness of the voluntary system could be enhanced further by information programs for consumers on the correct use and meaning of the recommended precautionary labelling statement
  

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  While the application of the VITAL system is expected to improve the use of precautionary labelling for food products made in Australia and New Zealand, a gap remains with regards to imported foods, where similar voluntary measures are not adopted by the country of export.
  

3.3.2 Recommendations

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  FSANZ to continue working with industry to support a voluntary system to improve the use of precautionary labelling through management of allergen cross contact.
  

In collaboration with the food industry, FSANZ to put in place a label monitoring program specifically designed to track improvements in allergen labelling practices with a particular focus on ‘source’ and precautionary labelling. The data gained would allow FSANZ to track the effectiveness of voluntary practices and would assist the industry in achieving its goal to provide accurate, useful information to allergic consumers.

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  FSANZ will consider the outcomes of reviews currently underway by overseas regulatory authorities on precautionary labelling.