Food Federation Germany represents the whole food sector in Germany and comments on the Food and Feed Omnibus with reference to the extensive comments made by FoodDrinkEurope (see Annex) that we contributed to and fully support. Our key asks are to extend the scope of the Omnibus Regulation beyond the scope now foreseen to ensure that key obstacles to innovation and competitiveness are covered. We also request that key better regulation instruments such as systematic impact assessments, systematic assessments of bureaucratic burden, systematic assessments of enforceability and of enforcement of legislation in member states as well as more systematic application of key legislative principles such as proportionality and subsidiarity are applied. The same holds true for the systematic application of the SME test to all legislation, also all implementing legislative acts. Much of the burden that hinders competitiveness and innovativeness of food businesses stems from pieces of legislation that have been established woithout prior impact assessment or which should have been evaluated a long time ago. One example is the Transparency Regulation (EU) 2019/1381 that creates massive administrative burden and slowed down authorisation procedures massively without delivering on consumer trust as it was meant to. The requirements regarding notification of studies, protection of confidentiality of data, and the ineffectiveness of the pre-submission advice for applicants cause substantial administrative burden and delays in the process. The validation of an application, with a legal deadline of 30 days, now takes on average 7 months, and the whole decision process has doubled to more than 3 years since 2021. Regulation (EC) No. 1924/2006 should have been evaluated by January 2013, hence almost 13 years ago. The Regulation is probably the single most restrictive legislation affecting innovation in the food area and the most difficult to enforce. Its pre-market authorisation procedure for all health claims made on food has never been subject to an impact assessment. The Regulation has effectively prevented the authorisation of health claims on foods - ever since the adoption of the first list of authorized health claims in 2012, only about one health claim has been authorized per year. Establishing an effectively unsurmountable obstacle to communication healthe effects of foods is not in anywayy justifiable. For more examples and all detailed legislation to be looked at we refer to the comments by FoodDrinkEurope in the Annex on 16 pages of tables and examples. Whilst the the call for evidence paper published by DG SANTE addresses important issues that should be covered, it certainly does not cover all or even the most relevant obstacles to innovation and competitivenes in the area of food and feed law. And finally, "Implementation" by member states should be an integral part of the omnibus exercise as well, as member states have in many instances aggravated the problems via application and/or additional legislation. To name but one example: Germany has maintained its general prohibition to add Vitamins A and D and all minerals to foods that the EU has authorized for that purpose in Regulation (EC) No. 1925/2006 some 20 years ago, hereby contradicting EU law. Another example: Regulation (EC) No. 1924/2006 on nutrition and health claims has been applied very differently in member states even though the there is extensive case-law of the ECJ - and much more by national courts on that basis. "Implementation" must therefore be part of the exercise of assessing EU food and feed law in the Omnibus. There are many more examples that go beyond what can be addressed here, be it on food labelling, contaminants, Article 8 procedures in Regulation (EC) No. 1925/2006, Hygiene and Control Regulations, Residue Regulations and many more that are mentioned in the Annex.
We hold the opinion that the "printing" described in the text of Annex I (14) of Directive 2014/31/EU does not necessarily have to be a printed paper slip in the sense of the regulation and under consideration of the technical possibilities now available, but that the provision of the required information in digital form can be interpreted as being compliant with the requirements of the Directive and that a change of the legislation is therefore unnecessary. From the point of view of sustainability in particular, it is highly desirable that the principle of "printing on demand" is followed and that a classic sales slip is only issued if this really meets the customer's request. If, however, the customer decides in advance to opt for a paperless variant, the e-slip, by having given their consent, they should be given the option of receiving their sales slip by e-mail (for their own printout) in PDF format. The purpose of this regulation is first and foremost to inform the customers directly, individually and on a permanent and available basis, as well as giving them the opportunity of checking (for an unlimited period of time) their purchase and the invoice components. This objective is by no means undermined by the digitized e-slip - quite the opposite. While the paper sales slip loses its readability over time due to fading, generally tears easily or gets lost on the way home, by having an e-mail sent to the customer they will have a permanent medium at their disposal within a few seconds after the purchase. The information and perpetuity function laid down in the law is complied with in full; the sales slip can also be checked directly at the cash register. When Directive 2009/23/EC of the European Parliament and of the Council of 23 April 2009 on non-automatic weighing instruments was created, which was later replaced by Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments, it was not possible to anticipate which technological innovations would be developed and, as a result, change user behavior and customer expectations without compromising the protective purpose of the regulation for the customer. Such technological innovations should be encouraged by a pragmatic interpretation of the existing legislation to the benefit of both users and customers. Moreover, a respective interpretation does not conflict with the scope of application of the Directive in question, nor does it curtail the merely reflexively intended legal protection of third parties. According to Recital 47, the Directive aims to ensure that non-automatic weighing instruments on the market fulfil the requirements providing for a high level of protection of public interests covered by this Directive while guaranteeing the functioning of the internal market. Furthermore, Recital 17 clearly demonstrates that this Directive should be limited to the expression of the essential requirements as regards metrology and performance in relation to non-automatic weighing instruments. Protected persons include "users" and "third parties" (see Recital 19). Regarding the context relevant here, third parties are the customers. According to Annex 1 (14), first of all, instruments shall safeguard customers against incorrect sales transactions due to their malfunctioning. However, the provision of an electronic sales slip upon request by the customer is based on a device that usually functions properly, with the result that there is currently no lack of protection. Finally, it should be taken into consideration that "this Directive does not go beyond what is necessary in order to achieve that objective" (see Recital 47), i.e. that the principle of proportionality (see Recital 47) must always be taken into account in all questions of interpretation.
Der Lebensmittelverband Deutschland e. V. vertritt die Interessen der deutschen Lebensmittelwirtschaft als gesamte Kette und steht im engen Benehmen mit den Zulieferbranchen. Von einem Verbot von Bisphenol A sind in der Lebensmittelbranche nicht nur die Verpacker bestimmter Lebensmittel und Importeure verpackter Produkte betroffen; in der gesamten Wirtschaft von Handwerk bis Industrie gibt es Anwender BPA-basierter Prozessmaterialien, die von den vorgeschlagenen Verbotsmaßnahmen zum Teil massiv betroffen sein werden. Seit vielen Jahren sind Bemühungen und Substitutionsprozesse in den Lieferketten in Gang; wo möglich wurde in Produkten mit unmittelbarem und intensivem Lebensmittelkontakt und Migrationsrisiko die absichtliche Verwendung von BPA durch geeignete und in der Funktionalität vergleichbare Stoffe ersetzt. Erforderlich sind jedoch i. d. R. sehr langwierige Qualifizierungsprozesse; auf den Zeitbedarf und den Aufwand sowie die Grenzen der Substituierbarkeit bei Materialien, wie u. a. Polycarbonat, wurde in der Vergangenheit in Stellungnahmen und Fachgesprächen häufig hingewiesen. Der Lebensmittelverband kommentiert vor diesem Hintergrund den vorgeschlagenen Entwurf und schlägt im Text vor.
Der Lebensmittelverband bedankt sich für die Möglichkeit, auf diesem Wege zu dem Entwurf einer delegierten Verordnung bezüglich der Definition von engineered nanomaterials (technisch hergestelltes Nanomaterial) Stellung nehmen zu können. Unsere Stellungnahme finden Sie im Anhang dieses Kommentars.
The Food Federation Germany (Lebensmittelverband Deutschland e. V.) is the leading association of the German food sector. In this role the Food Federation Germany represents the food sector throughout the entire production chain, from farm to fork, i.e. the areas of agriculture, food processing, food trade, and food retail. Food Federation Germany's membership includes some 70 associations, 250 companies ranging from mid-sized firms to international companies , as well as 150 organizational and individual members. The Food Federation Germany deals with a broad range of issues pertaining to food, including their scientific, legal, political and economic aspects. The Food Federation Germany's tasks include affecting and facilitating the development of German, European and international food laws and actively supporting the relevant scientific fields. It carries out its work on a solid scientific foundation. In addition, Food Federation Germany functions as a partner for dialog with political, administrative and scientific sectors, with consumer organisations and with the media, relative to the areas of food, food production, quality and safety, food law and consumer protection. The Food Federation Germany also works actively in the field oft he EU organic law and clearly rejects the Commissions Draft Delegated Act on Organic Salt Production Rules for the following reasons: Salt is a key mineral for food and feed. Salt is not organic and therefore the logic and principles of the EU Organic Regulation can hardly be transferred on salt production. The Draft would de facto exclude all German rock salt and vacuum salt producers from becoming organic. This means that moreover, more than 90 % of Europes salt production would be excluded from organic. The EUs ambition of 25 % organic production will not be achievable at all under these circumstances. The Draft Production Rules are not consistent, not science-based and not justified, e.g. a conversation period does not make sense for a mineral product. The Draft would exclusively prefer sea salt producers in coastal areas which would lead to long distribution distances and high CO2-footprints. Regarding rock salt and vacuum salt, the Commissions Draft Production Rules also ignored major parts of the reports and recommendations of the Subgroup Salt of the Expert Group for Technical Advice on Organic Production. Moreover, it is to criticize that representatives of the rock salt and vacuum salt sector were not nominated for this Subgroup, whereas several representatives of sea salt companies were nominated that do neither have proven expertise in rock salt and vacuum salt production nor validated reputation in the field of rock and vacuum salt science. Four years after adoption of the EU Organic Regulation 848/2018 the Commission fails to present a meaningful, consistent and applicable proposal for Organic Salt Production Rules. The Commissions Draft violates the objectives of the EU Organic Regulation, the salt sector itself opposes the Draft and also the downstream customers in our membership and the organic sector in Germany are very critical about it. Therefore, the Food Federation Germany recommends to withdraw the Draft and exclude salt from the EU Organic Regulation.
Food Federation Germany (Lebensmittelverband Deutschland e. V), the leading association of the German food sector, welcomes the opportunity to comment on the proposal to restrict the use of green-tea catechins (Epigallocatechin gallate (EGCG)) in foods.
We ask the Commission to take the following comments into account:
1. The European Food Safety Authority (EFSA) has concluded that catechins from green tea infusions and similar drinks are generally safe corresponding to a safe intake of at least 300 mg EGCG per day. Consequently, it is proposed to exclude such products from the scope of the regulation. However, all other foods that contain green tea extracts with the same or even smaller quantities of EGCG would be covered by the restrictions and would have to be labelled with several warning statements. We question the scientific justification of this divergence of approach and propose that a threshold-level is set for all foods below which no warning statements need be put on labels.
2. In addition, we question that the plethora of warning statements will achieve the aim of the necessary consumer information that we do of course support as such. The proposed five label statements on products containing green tea catechins, irrespective of the amount of green tea catechins they contain, should be reduced to the following: “Consumers should be informed about the content of catechins and the proportion of (-)- epigallocatechin-3-gallate per portion of the product together with the warning not to consume a daily amount of 800 mg of (-)-epigallocatechin-3-gallate or more.”
The additional warning “Should not be consumed if you are already consuming other products containing green tea” is then redundant and would even seem inappropriate as consumers could safely consume multiple products and not exceed intake of 800 mg/day. In addition, we question the scientific basis for a warning statement for specific population groups and for a general statement to consult a doctor in case of health problems. EFSA recommends the declaration of the content and the proportion of EGCG, but no warning statements.
3. Finally, companies need sufficient time to adapt their products to the new labelling requirements. They cannot initiate the necessary label changes before the legal requirements are officially adopted and the exact statements in all relevant languages are known. We therefore advocate a sufficient transition period that is a basic requirement of any proportionate regulatory measure to be set (e.g. for 18 to 24 months). All products placed on the market before the end of the transition period should remain on the market (if they apply to current national law) until sold.
In addition to the comments above, we refer to the comments issued by our European Federations FoodDrinkEurope and Food Supplements Europe that we fully support.
Berlin/Brussels, 3rd of November 2021
Lebensmittelverband Deutschland e.V. (Food Federation Germany) representing the German food sector “from farm to fork” in some 70 associations, 250 companies, and more than 150 personal and corporative members welcomes the opportunity to comment on the Commission’s plans for an Impact Assessment (IA) with regard to the “labelling elements” of the Farm to Fork Strategy as presented in the Inception Impact Assessment (IIA) and wishes to highlight the following:
• The scope of the IA needs to be extended beyond the issues of FOPNL, origin labelling and date marking to make sure the full potential of labelling for more sustainable food systems is properly assessed, to name but a few here: digital consumer information (Art. 12.3 FIC Regulation), precautionary allergen labelling ((Art. 36 (3) a) FIC Regulation, information on foods suitable for vegans/vegetarians (Art. 36 (3) b) FIC Regulation; taking the example of precautionary allergen labelling: whereas the understanding that very small amounts of allergens do not cause severe reactions is growing amongst scientists, the “zero-tolerance-approach” applied now unnecessarily limits consumer choice and causes unnecessary economic damage - and that is why EU-wide agreed “threshold levels” and approaches to may contain-labelling have to be established.
• All measures need to be science- and evidence based, and in that context full account needs to be taken, firstly, of all scientific and other assessment already done, for example of the EFSA on nutrient profiles in 2008 or of the various impact assessments on origin labelling that have been completed under the FIC Regulation in 2014/2015; in addition all research now needs to additionally focus on the new issue of sustainability that has not been assessed before.
• The IA needs to specifically assess the effects of the plethora of member state legislative initiatives that have in the last years filled the “void” caused by the lack of harmonised European legislation and initiative, many of which have not even been notified to the Commission; without a complete picture of all member states regulations and recommendations on origin labelling, nutrition labelling or any other labelling obligations, the Commission’s IA will not be complete and possibly be disregarding the negative effects of such member state legislation co-existing with future EU-legislation.
• The IA should positively assess the potential of voluntary measures for achieving the sustainability goals pursued and not merely discredit them as “Option 0” and “business as usual” as has been done in the IIA; harmonised criteria for voluntary consumer information may well prove to be the best option not only for agreement as such but also for establishing the sustainability goals pursued; and the IA must also assess what effect measures proposed may have on existing voluntary business models that have been succesfully established in response to consumer demand.
• The IA should also focus on the effects measures may have with regard to the basic principle of the free circulation of goods in the single market that has been established for a reason and on the basis of the understanding that prima facie a re-nationalisation of markets is against the interests of consumers and businesses and can therefore not be “sustainable”; and in that context the mere notion that harmonised legislation is “better” than member state legislation will in itself not suffice to justify for example replacing member state legislation on origin labelling that has virtually all been declared invalid by the European Court of Justice - as such harmonised legislation may still be negatively affecting the single market and prove detrimental to the sustainability goals pursued.
Detailed comments fully endorsing and in part incoporating FoodDrinkEurope's comments are attached.
Arbeitskreis Nahrungsergänzungsmittel (AK NEM) is part of Food Federation Germany (Lebensmittelverband Deutschland e. V.) and represents the German food supplement sector. AK NEM’s membership includes the leading brand and contract manufacturers, raw material suppliers and legal and scientific advisors to the sector.
AK NEM is concerned about the proposed prohibition of all foods containing extracts of Aloe spp. The general inclusion of aloe extracts in Part A of Annex III to Regulation (EC) No. 1925/2006 would also lead to a ban of Aloe vera-based supplements and products that only contain traces of hydroxyanthracene derivatives (HAD). Those products are not marketed for their laxative/bowel function improvement effects and are safe for human consumption, as has been demonstrated in numerous studies (see reference list of the attached statement for detail). A prohibition of these products is disproportionate and not scientifically justified. It would cause enormous economic damage without there being any sound evidence of health concerns related to these products.
The proposed approach is based on the opinion of the European Food Safety Authority (EFSA), published in 2017. EFSA, however, was asked to assess the safety of HAD in food supplements with laxative effect (›10 mg HAD/day), not the safety of the entire range of ingestible aloe products. As a result, EFSA did not consider all existing scientific data. In particular, the studies on purified Aloe vera whole leaf or inner leaf materials with only unavoidable negligible amounts of HAD were not critically evaluated. Also, all in all, the scientific evidence is characterised by great uncertainties.
The German Bundesinstitut für Risikobewertung (BfR) in 2017 assessed the risk of HAD (https://www.bfr.bund.de/cm/343/nahrungsergaenzungsmittel-mit-anthranoidhaltigen-aloe-ganzblattzubereitungen-bergen-gesundheitliche-risiken.pdf.) and came to the following conclusion: “Due to the suspicion that plant-based anthranoids have a carcinogenic effect in humans, the BfR does not consider preparations containing anthranoids to be suitable for use in foods, including food supplements. This assessment does not apply to preparations made from anthranoid-free gel or inner pulp from the leaves of Aloe species (mostly Aloe barbadensis or Aloe vera), which are commonly used in foods and cosmetics in the EU.”
Numerous toxicological studies support this point of view, consistently demonstrating the absence of adverse effect of purified Aloe vera whole leaf and inner gel ingredients used in foods and food supplements. The proposed regulation by the Commission fails to consider the totality of the available scientific evidence that supports the safety of such preparations of Aloe spp. Against this background it is not justified to unintentionally have these products affected by the proposed regulation, thus, banning them from the market.
Therefore, the scope of the regulation needs to be clarified. Inner gel products or purified extracts, that only contain negligible amounts of HAD in form of technically unavoidable impurities, should be exempted from the scope of the proposal. This could be achieved by establishing a threshold for residual HAD. For this purpose, a threshold of 0,5 ppm Aloin/final product seems to be feasible and sensible.
Moreover, due to the high degree of scientific uncertainty, other Aloe extracts, at least those with a HAD content below 10 mg/day, should be included in the scrutiny list. This will allow companies to provide new data on the safety of their products, which EFSA can take into account in an updated risk assessment. This will be in line with the legal requirement that in cases where uncertainty persists, substances should be put in Part C of the Annex.
As a member, we fully support the position of Food Supplements Europe, and would like to refer to their comments on this public consultation for more details.
Ionenaustauscher
Nach dem vorliegenden Vorschlag soll die Technik für bestimmte Produktkategorien (Babynahrung) zugelassen werden und für andere nicht (hauptsächlich Stärkeverzuckerung, Fruchtsaftkonzentrate, Balsamico-Essig, ...). Die Anwendung dieser Technologien in den letztgenannten Produktbereichen wurde wegen unklarer europäischer Vorschriften in einer Reihe von Mitgliedstaaten im Wege der Auslegung über lange Zeit für die Bio-Verarbeitung genehmigt. Eine unionsweite Klärung ist in dieser Zeit nicht erfolgt. Auf der Grundlage dieser nationalen Genehmigungen haben Unternehmen diese Techniken bei der Herstellung der Produkte über Jahrzehnte eingesetzt. Auf der Grundlage des freien Warenverkehrs für Produkte in Europa werden Erzeugnisse aus diesen Produktionen in vielen ökologischen Produkten, z.B. als Süßungsmittel, verwendet.
Angesichts der jahrzehntelang etablierten und von den Kontrollbehörden in den Mitgliedstaaten akzeptierten Nutzung von Ionenaustauschern für die genannten anderen Produktkategorien hat sich für die betroffenen Unternehmen zumindest für eine mehrjährige Übergangsfrist ein Bestandsschutz im Hinblick auf die künftige Nutzung von Ionenaustauschern entwickelt. Die Unternehmen haben ihre Rezepturen und ihre Prozesse im Vertrauen auf die bestehende Rechts- und Vollzugspraxis in den besagten Mitgliedstaaten umgestellt und mussten daher auch von der langfristigen Akzeptanz seitens Öko-Kontrollbehörden ausgehen. In diesem Glauben wurden Investitionen vorgenommen und Verträge mit Abnehmern der betroffenen Zutaten getroffen, die mit Blick auf das Verhältnismäßigkeitsprinzip nicht ohne angemessene Übergangsfrist gestrichen werden können, da die nachteiligen Konsequenzen der durch die geplante Rechtsänderung entstehenden Situation nicht den Unternehmen angelastet werden können. Ein kurzfristiges Verbot von Ionenaustauschern für die genannten anderen Produktkategorien ab 2021 hätte massive wirtschaftliche Folgen für die Unternehmen, die diese die Technologien jahrelang mit Zustimmung der zuständigen nationalen Behörden eingesetzt haben. Die Folge wäre eine komplizierte Umstellung der Prozesse, der Rezepturen und der Kennzeichnung vieler Produkte, die auf der Grundlage dieser Erzeugnisse hergestellt werden. Es ist daher zwingend notwendig, alle relevanten Anwendungen sorgfältig zu evaluieren und ihre Konformität mit den ökologischen Prinzipien im Sinne einer EU-weit einheitlichen Beurteilung zu prüfen. Dies ist bisher noch nicht erfolgt. Darüber hinaus müssen die wirtschaftlichen Auswirkungen sehr sorgfältig geprüft und bei der Entscheidung berücksichtigt werden. Für diese Umstellung, aber auch für die Evaluation der relevanten Anwendungen muss genügend Zeit eingeräumt werden.
Eine Übergangszeit von fünf Jahren ist aus Sicht der deutschen Lebensmittelwirtschaft daher zwingend notwendig.
BLL, the national federation of the German food sector, thanks the European Commission for the opportunity to provide comments on the draft proposal to set MRLs for chlorate in food in the framework to the European pesticide legislation.
In the past, chlorate was an active substance in plant protection (herbicide), but nowadays entries of chlorate in food are related to the use of chlorinated agents for the disinfection of drinking water, the treatment of water by food business operators to keep the microbiological quality of the water acceptable, the disinfection of surfaces and equipment, the use of processing aids etc. Entries of chlorate occur during the whole production process starting from the cultivation of the plant (irrigation water, fertilizers) over washing the raw agricultural commodity after harvest to food processing (esp. wet processing). As chlorate is not used, but formed as a by-product from chlorinated agents and several entries of chlorate during production may occur, levels of chlorate in end-products are unintended, varying and thus hardly predictable.
The MRLs proposed in the draft regulation SANTE/10684/2015 Rev. 3 seem to be based on data from food marketed to consumers (fresh, processed and composed food). However, according to Reg. (EC) No 396/2005 the MRLs directly apply to the commodities according to annex I of the regulation which are mostly (raw) agricultural commodities. The BLL therefore raises concerns how the proposed MRLs for chlorate are calculated. One example is sugar/sugar beet. As sugar is a refined product and does not contain chlorate, a MRL of 0.01 mg/kg for sugar beet is proposed. However, sugar beets are washed before processing (thus may contain chlorate) and other products made of sugar beets like proteins, starches and molasses may contain chlorate too. This clearly shows that it is not appropriate to calculate chlorate levels for a commodity according to annex I of Reg. 396/2005 from a processed raw material, ingredient or end-product. On the other hand, it is not appropriate to use a MRL for chlorate set for a commodity according to annex I also for processed raw materials, ingredients and end-products. Food processing is no post-harvest treatment of raw agricultural commodities and should not be considered in that way! According to the structure of Reg. 396/2005, new entries of chlorate during food processing are not covered by the regulation, and when the entry of chlorate is on the commodity according to annex I, article 20 of Reg. 396/2005 for processed and composed food is applicable.
According to EFSA, the main source of dietary intake of chlorate for the European population is via drinking water. As drinking water is chlorinated in many countries worldwide for safety reasons, the WHO has set a guideline value of 0.7 mg/L for chlorate. In the EU, currently a ML for chlorate of 0.25 mg/L is discussed in the context of the review of the EU drinking water directive. The BLL believes that it is not justified to set lower limits for chlorate in food than in drinking water. Also, the first priority should not be to set lowest chlorate limits in food but to secure the microbiological safety of water and food and thus the health of consumers.
Given the complex nature of entries of chlorate in food, the BLL believes that the European pesticide regulation (EC) No 396/2005 is not the right legal framework to set MLs for chlorate levels in food. This regulation works well for residues from plant protection, but structure and logics do not fit for entries from other sources. This is especially true for disinfectant agents and multiple source substances like chlorate. Should MLs for chlorate in food be set, a legal framework equally suitable for raw materials and end-products should be used (e.g. the European contaminants legislation). Also, the BLL deems it necessary to grant transitional measures for all kind of food which has been produced before the new limits become valid
We thank the European Commission for its intention to strengthen the application of the Mutual Recognition Principle and for consulting on the proposed revision of the Mutual Recognition Regulation.
BLL (Bund für Lebensmittelrecht und Lebensmittelkunde e.V.) represents the whole food sector in Germany when it comes to issues related to food law and food science, its membership encompassing inter alia farmers, industry, retailers and craftsmen, represented through 90 associations, 300 companies and 100 individual members. As members of FoodDrinkEurope and Food Supplements Europe, the associations representing our members’ interests on a European level, we fully support their submissions to the consultation and refer to the issues raised therein.
As a general comment: Even though food law is regarded as one of the most harmonised areas in EU legislation, the non-harmonised areas and national legislation filling the gaps and the then non-application of the mutual recognition principle lead to manifold barriers to the marketing of products throughout all Member States, resulting in lost markets and/or the need for reformulating products and changing labels. As more than 90% of the businesses we represent are small and medium sized, they would profit most if member states applied the mutual recognition principle as they should. But of course the same holds true in principle for all other companies.
The conclusions of the fitness-check evaluation on Regulation (EC) No. 764/2008 are clear: mutual recognition is not applied as it should be and there is need for e new approach to make it work. What is more: Most companies do not even know the procedure or if they do, do not use it, because experience shows it is easier to adapt products to national legislation. The key issue is that member states are unwilling to apply mutual recognition and put burden of proof for safety and compliance on the companies, whereas it should be on them to prove non-compliance and/or safety issues.
We therefore fully support the changes to the Regulation proposed by the Commission that we think will improve the situation, in particular the introduction of a self-declaration and the establishment of a problem-solving system.
In addition, we would like to raise the following questions and/or make the following more detailed comments that you find in the document attached:
Bund für Lebensmittelrecht und Lebensmittelkunde e.V. (BLL), representing the food sector in Germany, would like to thank the European Commission for giving the opportunity to provide feedback on the draft Implementing Regulation on Article 26(3) of Regulation (EU) No 1169/2011.
BLL and its members have contributed to the extensive contribution of FoodDrinkEurope to the public consultation on the Commission draft Implementing Regulation on Article 26(3) of Regulation (EU) No 1169/2011 that we fully support and refer to. We also refer to all contributions from member companies and member federations representing the different sectors of food chain, as well as to the dedicated contribution of Markenverband with regard to issues concerning brands and their exclusion from the scope of the implementing regulation.
We appreciate the progress made by the Commission and Member States in developing the draft text and we hope that final agreement on the Implementing Regulation can be found soon. Indeed, a harmonized approach is urgently needed to make a step forward towards the implementation of the origin labelling requirements laid down in Regulation (EU) No 1169/2011 and to reinforce the Single Market for foodstuffs.
However, it is clear that the draft as it is lacks legal clarity especially with regard to its scope, which would be a major setback as divergent interpretations in different member states could well be the result of any such lack in legal clarity. It is key that it is made as clear as possible that the Implementing Regulation does not interfere with and apply to designations that are subject to specific legislation such as protected designations and trademarks/brands. The same holds true for all names of foods that are part of the obligatory food in formation on all foods.
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Bund für Lebensmittelrecht und Lebensmittelkunde (BLL) represents the whole food sector in Germany.
BLL thanks the European Commission for sharing the roadmap on transparency and sustainability of the EU risk assessment model in the food chain in a public consultation.
The roadmap hints at important changes to the General Food Law Regulation and it is therefore with concern that we see
- the short consultation period on the proposed roadmap during the christmas holidays not allowing for sufficient time to first assess the results of the Fitness Check of the General Food Law that was only published on January 15th 2018,
- the reduced consultation period of 8 weeks foreseen for the legislative proposal,
- the ommission of an Impact Assessment for the draft legislative proposal
all of which are incompatible with all fundamental elements and committments of the European Commission's Better Regulation approach.
We have contributed to the fitnesscheck of the GFLR and highlighted the essential role of EFSA for a harmonised European risk assessment approach, welcomed EFSA's approach to transparency in the risk assessment process as a pre-requisite for robust risk assessments, made clear that a balance must be struck with regard to transparency and justified interests in areas such as intellectual property and incentives for innovation, and would again like to highlight that indeed EFSA has made very much positive progress in implementating the transpancy rules of the GFLR. We reference the approaches to transparency and data quality (http://www.efsa.europa.eu/en/press/news/170803) and independence (http://www.efsa.europa.eu/en/corporate/pub/policyonindependence).
Having said that, we regret that the roadmap
- does not provide information on how the envisaged measures will be established,
- does not indicate whether the changes to the GFLR will be specific or conceptual, so that we are not able to really understand what may or may not be proposed and what this would mean to the issues identified,
- does not indicate what effects the new rules on transparency would have on scientific studies supporting the risk assessment process
- does not indicate what is intended with regard to the scientific cooperation and involvement of Member States and its scientific bodies,
- leaves open many other questions as to effects on EFSA's scientific capacity and its ability to maintain a high level of scientific expertise.
These and many other questions indicate that such a key proposal on maybe the most important element of the European Food Legislation approach, namely sound and respected science as basis for food legislation, cannot be conceived without all the elements of the better regulation approach amongst which an Impact Assessment looking into all the options, effects and impacts is the most relevant.
In addition we do not see it as a realistic option that the legislative process is completed before the elections. We do not understand the rush with wich this initiative is taken whilst EFSA was out of the scope of the fitness check initially and has not been assessed by external experts, but only by the Commission internally - and whereas the 3rd evaluation of EFSA is underway, its conclusions will not be considered in the proposal neither.
We finally do not see it as appropiate to limit any assessment and proposal on transpareny issues on EFSA only, leave out other eminent findings of the fitness check relating to inter alia the issues of transparency in the risk management process, the gaps identified in the harmonisation of food safety measures, interpretation, implementation and enforcement differences relating to the GFLR between Member States, improving the RASFF and many others more.
In summary we are of the opinion that any attempt to addressing transparency must not be limited to EFSA, but needs to cover all aspects of the risk analysis process, including risk management.
The BLL, the umbrella association of the German food chain, thanks the European Commission for the opportunity to comment on the latest proposal of the “Regulation on establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food”. Due to the various concerned sectors we have concentrated our feedback on general remarks as other sectors plan to send individual comments on specific points. Upon this points we refer to the feedback given by those sectors.
We think that the current version of the proposal provides a legal framework that enables FBOs to mitigate acrylamide-levels in their product successfully. In particular the clear definition of benchmark levels, to be used as reference guides for the successful implementation of mitigation measures, is key following an approach which is flexible and takes into account the broad variety of concerned products.
Even though the current proposal provides a workable basis there are still some points we would like to raise:
As different as products, which are affected by this regulation, are the available mitigation measures which can be applied to reduce acrylamide in the different food categories. This illustrates the complexity of acrylamide mitigation. With this in mind, we would recommend in recital 10 the insertion of “all relevant mitigation measures” due to specific production, geographic or seasonal conditions or product characteristics which can lead to certain products which are unable to achieve the benchmark levels.
The impact of these various factors on the acrylamide formation should also be considered when benchmark levels are set in Annex IV. Taking into account the available data, we feel that some levels are set too low and are not based on fully data representative. The envisaged regulation should follow an evidence-based and reliable approach to ensure the equality of assessment of individual products. We also see the need to clarify the food category “Products similar to the other products in this category”, as it is unclear to which products it applies. Furthermore, it is unclear why the benchmark level for the aforementioned category is set lower than for other products within the overarching category.
The work on maximum limits, announced in recital 15, contradicts the flexible approach the European Commission has taken with the currently proposed regulation. As mentioned above, the broad variety of influencing factors in the formation of acrylamide, which makes it extremely challenging to predict the exact acrylamide content in end products, need to be considered. Therefore, static maximum limits disregard the natural variation of acrylamide levels in food. In addition, static maximum limits are likely to stop innovation, while the now envisaged approach leads to continuous efforts in mitigating acrylamide. Moreover, we would like to highlight that different regulatory approaches, dealing with the same contaminant, could result in legal fragmentation. Thus, we do not deem it expedient to consider maximum limits for acrylamide in food.
Regarding the definition given in recital 12 and Article 2, we are pleased to see that the current wording has allowed for a clearer differentiation between types of FBOs although in sections 2 and 3 further clarification is needed. This is especially important to avoid demarcation problems and inconsistent enforcement and prevent smaller enterprises from a disproportionate administrative burden.
We welcome the proposed regulation in terms of its building upon existing best practices to reduce levels of acrylamide in food. We believe that the mandatory implementation of best practices, using relevant mitigation measures to reduce acrylamide, is an effective and practical approach which respects specificity in managing acrylamide.