New Year, 125 New Functional Ingredients in the EU by Sebastian MELCHOR

The long-awaited Union list of novel foods has become law in the EU following publication in the Official Journal of Commission Implementing Regulation (EU) 2017/2470 on December 20. For the first time, any food business operator can use novel botanical extracts, vitamins, minerals, microalgae, proteins, etc. when following the conditions and specifications laid down in the Regulation.

Until now, only those companies to which the Commission decision authorizing the novel food was addressed, as well as those obtaining authorization through the substantial equivalence procedure could use the novel ingredients. Other companies needed to obtain the novel ingredients from those officially authorized suppliers.

Detailed conditions under which the novel food may be used, especially food categories and maximum levels, as well as additional specific labelling and other requirements are laid down for each of the ingredients, which include top-selling ingredients like chia seeds, noni juice, synthetic hydroxytyrosol, clostridium butyricum, bovine lactoferrin, low fat cocoa extract, etc.

From now on, once a novel food is authorized, it will be added to this positive list and there will be no need to apply for substantial equivalence to use it.

To protect the investment of the applicants, however, there is a period of 5 year of data protection, which means that the newly developed information used to get approval cannot be used by other applicants. This may provide a monopoly on the marketing of the food or food ingredient for 5 years, unless the applicant agrees to share the data or if another applicant obtains their own information to get approval.

Detailed rules on administrative and scientific requirements published

At the same time, two other Commission Regulations lay down the administrative and scientific requirements for authorization of novel food applications and traditional foods from third countries, which are subject to a fast-track procedure.

The legislative package can be found here:

Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

 

ASA withholds implicit ´as much as´ nutrition claim by Nikolaas Tilkin-Franssens

The recent Advertising Standards Authority (ASA) case deals with a Heinz baked beans tv ad. The commercial highlights the nutritional content of baked beans displaying the authorized claims ‘high in protein’, ‘high in fibre’ and ‘low in fat’. However prior to displaying the authorized claims for baked beans, the commercial makes an assertion about the protein, fibre and low fat content of an unidentified drink. A comment follows which associates the nutritional features of that unidentified drink with baked beans.

ASA found that such amounts to a ‘as much as’ claim which is not permitted under the Nutrition and Health Claims Regulation 1924/2006.

ASA Ruling of  29 November 2017 on HJ Heinz Foods UK Ltd Find: link

ECJ judges on appeal case regarding the assessment of botanical health claims by Nikolaas Tilkin-Franssens

Last Thursday, 23 November, the Court of Justice has ruled on the appeals brought by Bionorica and Diapharm in relation to the on-hold status of botanical claims. The latter two started proceedings against the European Commission claiming it failed its obligation to include botanical claims in the Union list of authorized claims.

Summarizing the key facts, the Commission had requested EFSA to suspend the evaluation of botanical claims. However the on-hold situation still applies up until today. For that reason, Bionorica and Diapharm demanded the Commission to proceed with the assessment of botanical claims and to instruct EFSA to proceed with their evaluation. The Commission replied by stating it should be allowed the time and context necessary to identify the best course of action. Following the Commission’s answer, Bionorica and Diapharm sought a declaration by the General Court that the Commission had failed its obligation to act. The General Court argued the Commission’s response was sufficient to end its failure to act. Furthermore, the General Court continued its reasoning by stating that action was inadmissible due to lack of interest by the applicants. It argued the on-hold regime allowing for the provisional use of botanical claims which have not been assessed did not negatively affect the rights of food business operators.

In their appeal before the Court of Justice, Bionorica and Diapharm argued that the letter from the Commission did not constitute a sufficiently defined position because it merely confirmed the ‘on hold’ situation. The ECJ affirmed that the Commission did not define what action it considered necessary to continue with the assessment of the pending claims. Thus, in the view of the Court the letters did not bring an end to the failure to act. Moreover, the Court disagreed with the General Court that the end of the on-hold status of botanical claims would provide no benefit to economic operators. The Court argued that even the rejection of a health claim could procure a benefit in terms of legal certainty.

That said, the failure to act by the Commission has not been established in the Judgement as the case was eventually dismissed due to the lack of legal standing of both parties.

Case C-596/15 P (Bionorica v Commission) of 23 November 2017 (link).

New Guidance on the application of the Quantitative Ingredients Declaration made available by Nikolaas Tilkin-Franssens

The Commission has adopted the Commission Notice on the application of the principle of quantitative ingredients declaration (QUID), which provides further explanation on the obligation to provide the quantity of ingredients as established under article 22 of the Food Information to Consumers Regulation (Regulation 1169/2011). Prior guidance dates back to 1998, thus long before the current Regulation 1169/2011.

The Notice elaborates on the three cases in which QUID is principally required with reference to various examples. Further, the derogations under Annex VIII are discussed and last the forms of expression and position of QUID on the label are considered.

Full text of the Notice (2017/C 393/05) can be consulted via the following link.

Belgian authorities provide guidance on the use of the term ´artisanAL´. by Nikolaas Tilkin-Franssens

The Federal Public Service Economy of Belgium has established guidelines on the use of the statement ´artisanal´ for both food and non-food products which are placed on the Belgian market.

Criteria are established which alleged ´artisanal´ products should satisfy. The claimed status should either relate to the intrinsic characteristics of the product (inter alia unprocessed, absence of additives) or the production process (authentic production methods which are mainly manual or craftsmanship). In addition, it has to concern a small scale production. The Guidance reiterates the prohibition on misleading food information under the Food Information to Consumers Regulation (Regulation (EU) No 1169/2011). Although the use of the term ´artisanal´ is thus not a legally defined statement, it should be observed its use does not concern misleading information. The responsible operator should be able to justify the statements made regarding the product. Misleading statements can be sanctioned with a penalty of 80.000 up to 200.000 euro. Note that the guidance requires also non-belgian manufacturers to adhere to the established standards.

The full text of the guidance is available in Dutch and French.

New Belgian decree on nutrients published by Joris Geelen

The decree removes maximum levels for several vitamin B sources, increases the maximum level of Vitamin C to 1 gram and introduces new mandatory warnings.

What will change?

The maximum levels are mainly based on the advice of the Superior Health Council of June 2015.[1]

The decree introduces the following changes: 

  • removal of the existing maximum levels for: vitamin B1 (thiamin), vitamin B2 (riboflavin), vitamin B12, pantothenic acid, biotin and chloride;
  • new maximum levels for boron (3 mg) and fluoride (1.7 mg);
  • increased maximum levels for the following nutrients: vitamin C (1000 mg), vitamin D (75 µg), vitamin E (39 mg), vitamin K (210 µg), folic acid (500 µg), iron (45 mg) and copper (2 mg); and
  • decreased maximum levels for manganese, from 5.25 to 1 mg and for nicotinic acid and inositol hexanicotinate (vitamin B3) the level is reduced from 54 to 10 mg

To ensure safe use, the following warnings will become mandatory in the labeling of foodstuffs containing (a daily dose that exceeds) the following levels of nutrients: 

  • 25 μg vitamin K: “Not suitable for people taking coumarin anticoagulants.”;
  • 1000 mg potassium: “Not suitable for elderly people or people with a renal disorder, insulin-resistant diabetes or people with arterial hypertension.”;
  • 10 mg zinc: “The intake of zinc should be limited to a period of a few weeks/months.”; and
  • Nicotinic acid or inositol hexanicotinate: “Not suitable for pregnant or lactating women”.


Other changes?

Furthermore, the decree simplifies the existing notification requirement for fortified foods. The notification procedure no longer requires a full list of ingredients of the fortified food product. Information on the added nutrients (type and amount) per recommended daily intake or quantity of the nutrient equivalent to the average daily nutrient intake, now suffices.

Lastly, the decree adds an additional provisions on mutual recognition. A written application can be submitted to the Belgian authorities with evidence showing that the product has been legally marketed in another Member State. Under the previous decree, firms could submit requests for derogation from the maximum levels to the Superior Health Council. 


When will it be applicable?

The decree was published on October 31, 2017. As a transitional measure, foodstuffs already placed on the market that do not comply with the provisions of the decree, but do comply with the provisions of the previous decree, can still be placed on the market until November 10, 2019. 

 

What about the other EU countries and the Commission?

Besides Belgium, most EU Member States have adopted maximum levels for vitamins and minerals.

Italy[2] and France[3] have set legally binding maximum levels for all vitamins and most minerals.  

Recently the Netherlands, one of the most liberal EU countries regarding the addition of nutrients or other substances, announced their intention to set a maximum level for vitamin B6. The levels, based on a report of the Dutch Food Safety Authority (NVWA), would be 21 mg for adults and 3-13 mg per day for children, depending on the age. The former would be lower than the upper level of 25 mg published by EFSA, and significantly higher than the low levels in Belgium (6 mg) and Italy (9.5 mg).

Germany is currently working on new maximum levels for vitamins and minerals.

 

Comments

As long as there are no EU-wide maximum levels set for vitamins and minerals, EU countries still have the right to set their own maximum levels in national regulation. This is often done based on a risk assessment of their local scientific bodies, and not by directly applying the tolerable upper intake levels for vitamins and minerals set by EFSA.

Although it is good to see that Member States are applying science-based policies, it is clear that, as long as the European Commission does not cut the Gordian knot and finally adopt EU-wide maximum levels, EU countries will each set their own levels based on their interpretation of the science. As a result, the mutual recognition principle does not always ensure EU wide acceptance when it comes to maximum levels of vitamins and minerals.

Recently though, in the case C-672/15, the Court found that, whilst France could maintain its own maximum levels, the absence of a procedure for authorizing food supplements marketed in other EU countries with levels above those limits made the legislation contrary to the principle of mutual recognition.

In its judgement the court also confirmed that maximum limits should be based on the most reliable scientific data available and the most recent results of international research. They may not be based merely on national scientific opinions, if recent international scientific opinions concluding in favor of the possibility of setting higher limits are also available on the date of the adoption of the measure at issue.

 

[1]        Opinion No° 9285 of the Superior Health Council in respect of the dietary recommendations for Belgium, issued on 7 September 2016 (http://www.health.belgium.be/nl/advies-9285-voedingsaanbevelingen-voor-belgie-2016, available in Dutch and French)

[2]        Apporti giornalieri di vitamine e minerali ammessi negli integratori alimentari (http://www.salute.gov.it/imgs/C_17_pagineAree_1268_listaFile_itemName_5_file.pdf)

[3]      Arrêté du 9 mai 2006 relatif aux nutriments pouvant être employés dans la fabrication des compléments alimentaires.

European commission authorized two new mineral substances by Joris Geelen

The European Commission has recently authorized two new mineral substances for use in food and food supplements.

Commission Regulation 2017/1203/EC of 5 July 2017 amended Directive 2002/46/EC for food supplements and Regulation 1925/2006/EC on the addition of vitamins and minerals and of certain other substances to foods. The two new mineral substances that were added are:

  • Organic silicon (monomethylsilanetriol) as source of silicium; and

  • Calcium phosphoryl oligosaccharides (POs-Ca®) as source of calcium.

The full text of this regulation is available on : http://eur-lex.europa.eu/eli/reg/2017/1203/oj

Implementing Regulation sets compositional and information requirements for total diet replacement. by Nikolaas Tilkin-Franssens

From 27 October 2022 total diet replacement products will need to comply with the requirements as set by implementing Regulation (EU) 2017/1798 of 2 June 2017 (see link below) on total diet replacement for weight control. The Implementing Regulation was published on 7 October 2017 establishing compositional criteria, labelling standards and the obligation to notify total diet replacement products in the member states of destination.

‘Total diet replacement’ concerns a particular category foods which are specially formulated to replace the whole daily diet, for use in energy restricted diets with the purpose of weight reduction when used as instructed. Total diet replacement products fall under the general framework of Regulation (EU) No 609/2013 of 12 June 2013 of foods for specific groups together with foods intended for infants and young children and foods for special medical purposes. The latter Regulation mandated the Commission to adopt specific rules for either category.  For that purpose Regulation 2017/1798 of 2 June 2017 was adopted.

The compositional criteria for total diet replacement products can be found in the Annexes of Regulation (EU) 2017/1798 of 2 June 2017. These comprise minimum requirements on the amounts of energy, protein, choline, linoleic acid and alpha-linolenic acid, carbohydrates and vitamins and minerals (Annex I) as well as specifications on the amino acid composition of proteins (Annex II). The addition of other substances is allowed insofar the suitability has been established by generally accepted scientific data.

Information requirements for total diet replacement adhere to the Food Information to Consumers Regulation (Regulation (EU) No 1169/2011), except for the introduction of certain mandatory statements and substantial deviations regarding the nutrition declaration. For instance, a statement indicating that the product is only intended for healthy overweight or obese adults who intend to achieve weight reduction should be included on the labelling. References to the rate or amount of weight reduction which may result from the use of total diet replacement are not allowed. Furthermore, the Regulation imposes that the nutrition declaration cannot be omitted for reasons of limited space on the packaging. The indication of vitamins, minerals, choline and added fibre in the nutrition declaration is mandatory. All amounts should be expressed on a per portion and/or per consumption unit as well as per total daily ration. Indication 100 g or 100 ml may be provided on a voluntary basis. Moreover, the Regulation allows for the indication of the amounts of components of carbohydrates and fats other than specified in Regulation 1169/2011, substances listed in the Annex to Regulation 609/2013 or other added substances. The use of reference intakes is excluded.

A general prohibition on the use of nutrition and health claims applies. Only, the indications ‘very low calorie diet’ or ‘low calorie diet’ and ‘added fibre’ may be provided under the applicable conditions.

Lastly, in line with Regulation 609/2013, the implementing Regulation requires total diet replacement products to be notified to the competent authority of each Member State where the product concerned is being marketed. For that purpose, a model of the label and other information  which may be requested by authorities should be forwarded. Member states may however provide for an alternative scheme to monitor compliance.

Full text of the implementing Regulation: Commission Delegated Regulation (EU) 2017/1798 of 2 June 2017 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for total diet replacement for weight control (EU O.J. of 7/10/2017)

Commission makes public the list of authorized novel foods by Nikolaas Tilkin-Franssens

The draft act establishing the Union list of novel foods in accordance with the new Novel Food Regulation (Regulation 2015/2283) has been published and is open for feedback to all interested parties. The establishment of the Union list of novel foods is highly anticipated as the exclusivity of novel food authorizations will cease.

Under the former Novel Food Regulation (Regulation 258/97), an authorization by Commission Decision was exclusively directed to the applicant. An extension to other manufacturers or distributors for the same novel food or novel food ingredient had to be obtained by notification on the basis of substantial equivalence. That way only authorized providers were allowed to supply the particular novel food or novel food ingredient. The diverging procedures also made that authorizations and notifications of substantial equivalence were fragmented over different acts. Although a novel food catalogue and lists of notified novel foods had been established, the existing scheme was impractical and incomplete.

With the new Novel Food Regulation a single positive ´Union list´ of novel foods is introduced. The list creates a general authorization for the included novel foods provided the applicable conditions of use and labelling requirements are complied with. This feature extends to novel foods which have been authorized or notified in accordance with the former Novel Food Regulation. Future providers may benefit from the Union list upon its publication expected on 1 January 2018.

In anticipation of the actual adoption, the Commission has published a draft of the implementing act establishing the Union list including all former authorized novel foods (link).

Precautionary principle not a sufficient ground to restrict the cultivation of authorized GMO argues cjeu by Nikolaas Tilkin-Franssens

In the Judgement of 13 September 2017 the legality of an Italian Decree prohibiting the cultivation of an authorized GMO maize was examined. The ruling relates to article 34 of Regulation 1829/2003 on genetically modified food and feed which regulates the adoption of emergency measures by the Commission or alternatively individual member states. The article provides that where it is evident that authorized GMO products are likely to constitute a serious risk to human health, animal health or the environment, measures shall be adopted in accordance with the procedure laid down in the articles 53 and 54 of Regulation 178/2002 (General Food Law Regulation). The latter procedure provides that a member state may adopt interim protective measures where it officially informs the Commission of the need to take emergency measures and the Commission refrains from taking action.

The Court examined whether national interim measures under article 34 Regulation 1829/2003 can be based solely on the precautionary principle. It concluded that member states must observe the substantive condition that the authorized products are likely to constitute a serious risk to human health, human health, animal health or the environment. The existence of a serious risk must be based on scientifically substantiated risk assessment which justifies the adoption of restrictive measures in the given case.

The Judgement restricts the discretion of member states to bar the cultivation of authorized GMOs within their jurisdiction. It provides a clear confirmation that a burden of proof exists for member states. Restrictive interim measures require scientific evidence substantiating a potential and serious risk to human health, animal health or the environment. The Judgement will however not slam the shut door for the cultivation of GMOs in the EU. Somehow contrary to the judgement Directive 2015/412 provides a set of compelling grounds by which EU member states can restrict the cultivation of GMOs on their territory. Though, it requires such restrictions to be in conformity with Union law, reasoned, proportional and non-discriminatory. A new case in the making?

Full text of the ECJ Judgment (C‑111/16) via the following link

Italy introduces mandatory origin labelling for rice and durum wheat pasta by Nikolaas Tilkin-Franssens

On August 16 and 17, Italy has published two decrees which will require the mandatory labelling of the origin of rice and the origin of durum wheat used in durum wheat pasta. Manufacturers and distributors have until February 2018 to adapt their labelling to the newly introduced rules.

The Decrees are introduced as an experiment and will temporarily apply until end of 2020. Although, products manufactured or distributed in other member states are exempted from the obligation to provide the country of origin, the obligation will clearly create a noticeable distinction between Italian and non or only partly Italian produce. The Decree on durum wheat pasta, requires Italian dry pasta to label both the country where the wheat was cultivated and the country of milling. The Decree on the origin labelling of rice requires the indication of the country of cultivation, the country of elaboration and the country of packaging.

Although Italy had notified the initiative earlier this year, the adoption came as a surprise. The draft decrees had been communicated in accordance with article 45 of the Food Information to Consumers Regulation (Regulation 1169/2011), but before the Commission had adopted a final position Italy had repealed the notification. That way, Italy avoided anticipated objections as member states are divided over the benefits of origin labelling. Implementing rules on origin labelling are foreseen by article 26 of Regulation 1169/2011. The blunt manoeuvre is likely to spark the debate. While origin labelling increases transparency for consumers it conflicts with the level playing field the single market is supposed to establish. All eyes are on the Commission on how it will deal with this hot potato.

The full text of Decreto 26 luglio 2017 Indicazione dell’origine in etichetta del riso (Indication of the origin in the labelling of rice) has been published in the Gazzetta Ufficiale of 16 August 2017.

The full text of Decreto 26 luglio 2017 Indicazione dell’origine, in etichetta, del grano duro per paste di semola di grano duro (Indication of origin in the labelling of durum wheat for semolina pasta from durum wheat) has been published in the Gazzetta Ufficiale of 17 August 2017.