Since the discovery by Swedish scientists that acrylamide is formed during browning processes in foods containing starch, the industry and the Legislator must concern themselves with this topic, because acrylamide was and is classified as carcinogenic.
In a cooperation between industry, scientists and the authorities, signal values were developed in the following years. These were intended to oblige manufacturers to take action if they were exceeded, but said nothing about whether they were fit for human consumption. The German baking sector was able to deal with these signal values very well: there is no other product in which acrylamide levels are as low as they are in bread and baked goods.
The 2015 risk assessment
A new risk assessment by the European Food Safety Authority (EFSA) raised the stakes on the topic of acrylamide in the summer of 2015. EFSA, the EU’s highest body on food safety, now classified acrylamide as “potentially carcinogenic”. However, since there are no reliable human studies on the risk of cancer, EFSA applied the precautionary principle: acrylamide was to be handled in future according to the ALARA principle (As Low As Reasonably Achievable).
Initially, this gave the EU Commission a reason for a further decrease in the signal values, which were to be reduced from 150 µg/kg for soft bread to 80 µg/kg across the board. This could have led to an increase in transgressions for rye baked products, which form more acrylamide than wheat products. The German Plant Bakers Association achieved a split of the values into 80 µg/kg for “Wheat-based soft bread” and 150 µg/kg for “Soft bread based on other types of cereals”.
However, consideration was also given to formulating a proper EU Regulation on acrylamide that would promote the systematic reduction of acrylamide and was intended to introduce a sampling regime for acrylamide. Until then, regulation took place based on EU Commission recommendations.
Regulation 2017/2158
After several draft versions, in part with considerable changes to their content, the “Commission Regulation (EU) 2017/2158 of 20th November 2017 establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food” was published in the EU Official Journal. The Regulation is on the one hand a continuation of the Commission’s recommendations, but on the other it also contains new and hitherto unknown approaches.
The Regulation’s title already indicates that its topic relates to minimization measures for acrylamide and acrylamide guideline values. One point that is important in practice is not mentioned in the title, namely an obligation for the industry to take samples, analyze them and to record the results. This point has practical importance, because this obligation is differentiated by the Legislator according to business size, and so are the minimization measures that are to be adopted. It can be roughly summarized thus: big businesses must do more. This differentiation is enshrined in Article 2 of the Regulation. A criticism that must already be raised at this point is that Article 2 is difficult to understand, and is hard to read due to numerous references to the Annexes. An even more serious problem, however, are the many undefined legal terms which Article 2 contains or to which it refers. The three Sections of the Article require the following comments:
Article 2, Paragraph 1
“Food business operators which produce and place on the market foodstuffs listed in Article 1(2) shall apply mitigation measures provided for in Annex I.”
Applicability: Effectively, this obligation applies to all companies except small artisan businesses, see further remarks on this subject below.
Obligations:
Essentially, this creates two groups of obligations:
1. Minimization/mitigation measures pursuant to Annex I of the Regulation must be checked and documented.
2. Sampling, analysis and recording must be carried out for this purpose (Annex III).
1. The first group of obligations in Annex I consists of minimization measures which the sectors compiled in so-called Codes of Practices at that time. The measures for Bread and Fine Bakery Wares are applicable to the baked goods sector.
In the case of minimization measures, a check must be made in the business as to whether these measures can or cannot be implemented. The main question that plays a role in this respect is whether there is a negative change in the organoleptic pro-
perties or required product design of the baked goods. For example, if in principle a bread can be less browned in order to generate less acrylamide, but the baker discovers that he is no longer able to obtain the product he wants to manufacture, there is no compulsion to carry out the measure.
Written records must be kept about all the minimization measures.
2. The second group of obligations (obligation to take samples, analyze and keep records) is comprehensively described in Article 4 and Annex III of the Regulation. It follows from this that food business operators must design and carry out their sample-taking and analysis programs on their own responsibility. The samples being taken have to be representative and must represent the product types manufactured in the business operation. The business operator must decide exactly where the dividing line between different product types is to be drawn. The wording of the legislative text on this point is: “A ‘product type’ includes groups of products with the same or similar ingredients, recipe design, process design and/or process controls where these have a potential influence on acrylamide levels in the finished products.” Thus in concrete terms, the baker can also define similar products, e.g. various rye mixed breads, as a single product type and can sample them collectively.
As a basic principle when taking samples, the focus should be on products that have shown a potential to exceed the guideline values. Moreover, sampling should take place in a risk-based way, i.e. the food business operator can use his own risk assessment as the basis for the sampling and analysis plan for acrylamide.
In the case of products with a known, well-controlled acrylamide content, samples should be taken once a year, and more often for products with the potential to exceed limits. (Annex III, Paragraph III.)
Finally, business operators have an obligation to make the results of the analyses available to the authorities every year “on request”. (Annex III, Paragraph V)
Article 2, Paragraph 3
“Food business operators referred to in paragraph 2 which operate in facilities under direct control and that are operating under one trademark or commercial license, as a part of, or franchise of, a larger, interconnected operation and under the instructions of the food business operator that centrally supplies the foodstuffs referred to in Article 1(2), shall apply additional mitigation measures set out in Part B of Annex II.”
Applicability: In the first place, without wanting to go too deeply into the complicated wording, it can be said that this Paragraph is intended to cover chain and franchise companies.
Obligations: The obligations applying to these business operations are the same as for operations under Article 2, Paragraph 1: checking and documenting minimization measures and the duty to keep records. There is an additional obligation to comply with Annex II, Part B. However, this Annex only says:
1. General requirement FBOs (Food Business Operators) shall accept products referred to in Article 1(2) only from FBOs that have implemented all mitigation measures set out in Annex I. (…)
3. Bakery products FBOs shall monitor the level of acrylamide in finished products to verify that the mitigation measures are effective in keeping acrylamide levels below the benchmark level.
It remains open how Point 1 is to be monitored. Acrylamide content monitoring as required in Point 3 already takes place according to the obligation groups mentioned above, so there are doubts as to which new duties Annex II, Part B is intended to contribute.
Article 2, Paragraph 2
“By way of derogation from paragraph 1, food business operators producing foodstuffs listed in Article 1(2), which perform retail activities, and/or directly supply only local retail establishments shall apply mitigation measures provided for in Part A of Annex II.”
This ruling affects small artisan businesses. (fordifferenciation, see below)
Obligations:
1. Minimization measures according to Annex II, Part A
This contains a catalogue of minimization measures that is more restricted compared to Annex I, but which overlaps with the latter in many respects. In particular, the maintenance of product quality is of topmost priority here again, and is a precondition for introducing minimization measures.
2. Restricted documentation of minimization measures
According to Article 4, Paragraph 6, small businesses need only be in a position to produce documentary proofs of these minimization measures, but need not carry out thorough documentation. There is no duty to take and analyze samples
Differenciation
In particular, the exact differenciation between small artisan businesses and the other businesses mentioned in Article 2 is difficult in practice. This is mainly due to the fact that the Legislator has not described exactly which businesses belong to one category or to the other. All that is certain is the Legislator’s wish not to impose disproportionately large monitoring burdens on small businesses.
For this reason, immediately after the Regulation was published, the Commission prepared a so-called Guidance (“Guideline”). This Guideline interprets the Regulation, but without itselfbeing legally binding, and the measures are noncommittal. Nevertheless, in practice many administrative bodies and businesses will align themselves to these measures.
The Guidance mentions numerous possible criteriae to differentiate between “small” and “large” business operations:
+ The EU SME definition
Small and medium-sized enterprises (SMEs / micro and small enterprises) should be included among companies in accordance with Article 2, Paragraph 2. According to EU Commission Recommendation 2003/361, a company is an SME if it employs fewer than 250 (not more than 249) persons and has an annual turnover not exceeding EUR 50 million and/or an annual balance sheet total not exceeding EUR 43 million.
+ “Local” businesses
The definition of exactly what constitutes a local business is supposed to be specified at national level, but a catchment area of 100 km is suggested as a possible indication.
+ Additional criteriae include the ratio between turnover in consumer business and delivery to other local businesses, only occasional/seasonal supplying, the number of local businesses supplied to, and other criteria which the competent authorities consider to be relevant.
+ Membership of an association
The sector’s membership in a particular European sector association is also seen as a possible classification indicator. However, this criterion has so little discriminatory power that its validity must be called into doubt. An example is the German Plant Bakers Association: it is represented on EU level via the AIBI, the International Association of Plant Bakers. AIBI members are in turn classified in the Guidance among the businesses that are in accordance with Article 2, Paragraph 1. However, the German Plant Bakers Association also represents numerous branch bakeries of various sizes whose allocation to Article 2, Paragraph 1 is not self-evident. Paragraph 3 or Paragraph 2 may also be applicable to these businesses, depending on their size and organization form. On the other hand, no bakery business that can be classified as a chain or franchise business is represented in the Association Serving Europe, which is allegedly definitive for Paragraph 3.
Guidance values
When dealing with the Acrylamide Regulation, an understanding of the guidance values for acrylamide is of decisive importance. The following guidance values are defined in the Regulation:
Soft bread µg/kg
a) Wheat-based bread 50
b) Soft bread other than wheat-based bread 100
Cookies and waffles/wafers 350
Crackers, except potato-based crackers 400
Crispbread 350
Lebkuchen 800
Products similar to other products in this category 300
Analytical methods
Regarding the level of the guidance values it may be noted that it is questionable whether, at least in the case of “wheat-based bread”, th low value of 50 µg/kg makes sense in practicesince it is already close to the analytical detection limit. Although modern analytical methods are technically able to measure values of 10 µg of acrylamide, the measurement inaccuracy in this region is very large, and thus the occurrence of false positive findings is likely. Due to this uncertainty, as a rule even the Max-Rubner-Institute1 does not take any account of measured values below 50 µg/kg. Many quality assurance departments in bakeries even state that a considerable proportion of the positive analyses above 50 µg/kg are attributable to measurement inaccuracies and fluctuations in sample preparation.
Significance of the Guidance Values
The Legislator has stressed on several occasions, in both the legislative text and in the Guidance, that the Guidance Values – like the signal values that previously existed – are not legal limits / maximum values. Thus the Definition of Terms in Article 3, Paragraph 2 says:
“ ‘Benchmark levels’ means performance indicators used to verify the effectiveness of the mitigation measures and are based on experience and the occurrence of acrylamide in broad food categories.”
The context is stated in even greater detail in Recital 10 of the Regulation:
“It is acknowledged that the specified food categories are in certain cases broad and that for specific foods within such a broad food category there may be specific production, geographic or seasonal conditions or product characteristics for which it is not possible to achieve the benchmark levels despite the application of all mitigation measures. In such situations, the food business operator should be able to show the evidence that he applied the relevant mitigation measures.”
Thus an exceedance of Guidance Values does not in any way result in a product becoming unmarketable, but initially only triggers further obligations to investigate, and to provide proof if necessary.
Guidance Values as “quasi-legal limits”: an aberration
A regrettable trend in recent years is that stakeholders in both the food retail and consumer protection organizations tend to regard signal and guidance values as “quasi-legal limits”. Transgression can then lead to delisting in retail, or to downgrading in the context of product tests in the case of consumer protection groups. Neither of these is appropriate, since the guidance values – as explained above – say nothing about the quality or health acceptability of a food. Nevertheless, this emphasizes the great practical importance of appropriate guidance values forbakery wares.
Classification of specific products
Firstly, the Acrylamide Regulation creates “roughly defined” product groups in the baked goods area (e.g. “Soft Bread”), but secondly goes into great detail for certain baked products (e.g. Crispbread or Lebkuchen). In view of the great diversity of products, especially in the range of German baked goods, the question that arises repeatedly is where any given bakery wares are to be classified in this system. The following legal sources may play a role in this respect:
The text of the Regulation
In the first place, the Regulation itself can be consulted with regard to classification. For example, the relatively broad product group comprising “Soft wheat-based bread” covers the lion’s share of these baked goods, but, as already mentioned, the descriptions “Cookies and waffles/wafers”, “Crackers”, “Crispbread” or “Lebkuchen” are very specific.
Guidance
The content of the above-mentioned Guidance accompanying the Acrylamide Regulation is also important. At least a few indications about the possible interpretation of the product groups are given here. Pumpernickel2 may be quoted as an important example in this respect. According to the first draft version of the Guidance, this was still said to be classifiable as “Soft bread”. After an intervention by our association, it has now received its own guidance value of 300 µg/kg, which allows sufficient latitude for this special product.
Monitoring recommendation
Finally, after the release of the Guidance, the Commission formulated a Draft Commission Recommendation regarding the monitoring of acrylamide in certain foods (Document SANTÉ/10710/2018). This draft has direct effects on the understanding of the Guidance Value. However, at the time of publication it was available only as a draft version in English and not in other languages.
In its Annex, the draft recommendation names certain foods for which it was not yet possible to specify an acrylamide guidance value due to the lack of a sufficient data base. The Commission recommends these foods for monitoring by the authorities and industry. The Annex includes the following products in the Baked Goods area:
Bakery products (Baked goods)
+ Rolls (hamburger rolls, whole wheat rolls, milk rolls, …)
+ Pita bread, Mexican tortillas
+ Croissants
+ Doughnuts
+ Specialty bread (such as pumpernickel bread, ciabatta with olives, onion bread, ….)
+ Pancakes
+ Crisp cookies from a thin strip of dough and deep fried
+ Churros
This Draft Recommendation requires several comments:
1. No guidance values for products in the monitoring document
The German Federal Ministry for Food and Agriculture (BMEL) has made it clear that the products named in the Monitoring Recommendation are currently not subject to any guidance value for acrylamide. Dr. Annette Rexroth, responsible in the Ministry for the subject of acrylamide, formulated this as follows in a letter accompanying the Monitoring Recommendation:
“Currently, the question remains open which guidance values are to be specified for these products in the future. Therefore, the guidance values in Annex IV of Regulation (EU) 2017/2158 should not apply to the foods named in the Recommendation. I have notified the competent authorities in the German Länder (federal states) accordingly.”
In the opinion of the German Plant Bakers Association, this legal view is appropriate and welcome indeed. Temporarily excluding from the guidance value regime product groups that remain unclear defuses the somewhat heated debate about the “true” guidance value. Simultaneously, it gives industry and state institutions time to collect more data on the basis of which to define a guidance value that can be complied with in practice.
2. Bread rolls
With this in mind, it is logical that the bread rolls product group in its entirety is subject to the Recommendation, and thus not to the Regulation’s guidance values. This was previously not the case: the Acrylamide Recommendations lumped bread and rolls together in a single product group. That is inappropriate, because although bread rolls are similar to bread in many respects, they have a considerably larger specific surface. The surface of rolls is where the greatest formation of acrylamide takes place. Therefore there is a need to check whether more latitude is needed for bread rolls of all kinds.
3. “Specialty Bread”
The sheer endless variety of bread products is taken into account by including Specialty breads in the Monitoring Recommendation. This creates an opportunity to establish clarity for all products outside of the special categories named by the Regulation itself, without for the time being any need to fear the Damocles sword of an unclear guidance value assignment. Bakeries should use this opportunity, and should build up series of analyses for baked goods suspected of forming more acrylamide.
4. Sampling croissants and doughnuts is unnecessary
Finally, it is not comprehensible why the Commission includes croissants and doughnuts in the product group for monitoring, since the unanimous experience among bakers is that these two products have never yet been susceptible to acrylamide formation. The German Plant Bakers Association explicitly opposed this inclusion, both in relation to formulating the Guidance and regarding this Recommendation, but was ignored up to now. In our view, sampling these two products is unnecessary and generates superfluous costs.
Whether the present draft of the Monitoring Recommendation for acrylamide will undergo further changes remains to be seen.
Legal limits for “baby food”
In February 2019, the “Working Group on Environmental and Industrial Contaminants in Food” of the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) discussed initial proposals for maximum levels of acrylamide in foods for infants and young children. The consultation paper contains proposals for maximum acrylamide levels in biscuits and rusks for infants and young children (150 μg/kg) and in baby foods, processed cereal based foods for infants and young children excluding
biscuits and rusks (50 μg/kg). Thus “real” legal limits for acrylamide are being discussed, albeit only in the limited area of foods for infants and young children.
Summary and outlook
Although the Legislator has now issued a Regulation, this is by no means a satisfactory solution for the subject of acrylamide. This is for several reasons.Firstly, the Regulation itself is complicated and partially not very clearly worded, whereupon the Commission found itself compelled to tack on a Guidance as an interpretation aid. By doing this, the Commission followed the bad example of other Regulations which, as it were, had to be explained by an Appendix and “somehow” made fit for purpose. This is not only poor legislative drafting, but also creates legal uncertainty which is hard to endure, because everyone who is subject to the legislation – bakers just as much as the food supervision agency – must gather together the truth for themselves between the law and the interpretation aids. Consequently, this solves neither the question of who must take acrylamide samples and how many, nor the question as to which baked products are subject to which guidance values. Admittedly: both sets of questions have a variance range and need a certain amount of practical leeway, but slightly more orientation from the Legislator would have been desirable. After all, it involves considerable commercial expenses (analysis costs, reference value categorization, risk of delisting/downgrading).
The criteriae by which the Legislator will shape the next act in the acrylamide drama remain to be seen, namely establishing “real” legal limits. This has been scheduled for the period after the next Review, i.e. the next revision of the Acrylamide Regulation in about 2 years. Against this background, it is extremely important for industry to collect analysis data, especially in the case of products whose acrylamide content has still not yet undergone much research. As far as possible, these results should be collected together in a monitoring exercise throughout the sector, to be able to join forces politically to push through guidance values that are appropriate in actual practice.
Author
Alexander Meyer-Kretschmer,
Attorney-at-Law, Managing Director of the German Plant Bakers Association, focusing on food law
[email protected]
