VEGETARIAN AND VEGAN ON THE EUROPEAN LEGISLATIVE AGENDA by Nikolaas Tilkin-Franssens

The European Commission has announced that it will initiate the process for the adoption of a regulatory framework for vegetarian and vegan food. the Decision follows from a citizens initiative and will consider the mandatory labelling of foods as respectively non-vegetarian, vegetarian, or vegan. The anticipated proposal will also involve the establishment of definitions on the terms ‘vegetarian’ and ‘vegan’.

Commission Decision (EU) 2018/1701 of 7 November 2018 on the proposed citizens' initiative entitled ‘Mandatory food labelling Non-Vegetarian/Vegetarian/Vegan’- link

UK ASKS INDUSTRY INPUT ON POST-BREXIT FOOD LABELLING TRANSITION by Nikolaas Tilkin-Franssens

Previously the UK authorities indicated the leave from the European Union would have an immediate impact on food labels in case no deal would be negotiated. In the no-deal scenario, prepacked food products would have to include a responsible operator (i.e. manufacturer, importer or distributor) established within the UK from 29 March 2019. However, in order to provide some leeway to businesses and secure food availability in Britain, the UK authorities opened a consultation to get feedback on the installation of a transition period. The deadline for the consultation is set on 4 December.

UK Department for Environment, Food and Rural Affairs - Food labelling: amending laws - link

EGG MEMBRANE HYDROLYSATE RECEIVES NOVEL FOOD AUTHORIZATION by Nikolaas Tilkin-Franssens

Egg membrane hydrolysate will be authorized for use in food supplements intended for the general adult population from 25 November. The authorization is based on proprietary data making the authorization, founded on the provided data, is exclusive to the applicant Biova. The egg origin of the ingredient should be labelled in correspondence with allergen labelling rules.

Commission Implementing Regulation (EU) 2018/1647of 31 October 2018 authorising the placing on the market of egg membrane hydrolysate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 - link

 

CRANBERRY EXTRACT POWDER, REFINED SHRIMP PEPTIDE CONCENTRATE, AND BOVINE MILK BASIC WHEY PROTEIN ISOLATE AUTHORIZED AS NOVEL FOODS by Nikolaas Tilkin-Franssens

Three novel foods specifically targeted for use in special purpose foods will be added to the Union list of authorized novel foods following the Commission Regulations of 30 October 2018. Cranberry extract powder will be permitted for use in food supplements intended for adults. The approval was obtained with protection of proprietary data providing an exclusive authorization for the applicant Ocean Spray Cranberries Inc. until November 2023. Other applicants may obtain concurrent approval on the basis of legally obtained information supporting safety substantiation. Likewise, refined shrimp peptide concentrate and bovine milk basic whey protein isolate are authorized for use with proprietary data protection to the benefit of the applicants. The authorization of refined shrimp peptide concentrate relates to food supplements only, while bovine milk basic whey protein isolate shall be allowed in infant and follow-on formulae, total diet replacement foods for weight control, foods for special medical purposes as well as food supplements.

Basic whey protein isolate from bovine milk allergen will require milk allergen labelling. In addition, the warning “This food supplement should not be consumed by children/adolescents (depending on the age group the food supplement is intended for) under the age of three/eighteen years” should be included when used in food supplements.

Commission Implementing Regulation (EU) 2018/1631 of 30 October 2018 authorising the placing on the market of cranberry extract powder as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 - link

Commission Implementing Regulation (EU) 2018/1633 of 30 October 2018 authorising the placing on the market of refined shrimp peptide concentrate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 - link

Commission Implementing Regulation (EU) 2018/1632 of 30 October 2018 authorising the placing on the market of bovine milk basic whey protein isolate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 - link

FRANCE SUSPENDS THE USE OF TITANIUM DIOXIDE by Nikolaas Tilkin-Franssens

On 30 October, France published a law which suspends the use of the food additive titanium dioxide with corresponding E-number 171. The measure has been taken based on article 54 of the General Food Law (EU Regulation 178/2002) which permits member state to take emergency measures where the Commission is considered not have acted adequately to a notified food safety risk. In April 2018, France had expressed safety concerns with the European Commission due to the publication of new scientific studies on titanium dioxide. The Commission then requested the EFSA to assess the studies. In its opinion of 26 June, the latter argued the studies were not conclusive on the asserted safety risks. Additional studies conducted under more realistic conditions would be needed. On that basis, the EFSA argued it would not reconsider its existing opinion on titanium dioxide as a food additive.

The Commission will have to put the matter to the attention of the other EU member states in the Standing Committee on the Food Chain and Animal Health. It shall then be decided whether the measure should be extended - for instance to all member states - amended or abrogated.

Article 53 - LOI n° 2018-938 du 30 octobre 2018 pour l'équilibre des relations commerciales dans le secteur agricole et alimentaire et une alimentation saine, durable et accessible à tous - link

ALTERATION OF FOOD SUPPLEMENTS’ ADDITIVES DIVISION by Nikolaas Tilkin-Franssens

The sections listing the authorized additives for use in food supplements have been revised by the European Commission. The update deletes the current third category 17.3 (food supplements supplied in a syrup-type or chewable form) as the application of this category raised complications in its differentation with liquid and solid food supplements. Syrup-type food supplements are now subject to the liquid food supplements list and chewable food supplements to the solid food supplements list.

Moreover, the introductory part of both sections now clarifies that the maximum levels of the indicated additives apply to the food supplements as ready for consumption. The latter should be interpreted as prepared for consumption in accordance with the instructions provided by the manufacturer.

Commission Regulation (EU) 2018/1497 of 8 October 2018 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards food category 17 and the use of food additives in food supplements - link

COMMISSION ADOPTS TRANS FAT BAN PROPOSAL by Nikolaas Tilkin-Franssens

With trans fatty acids posing a public health risk to consumers, the Commission adopted a proposal which would limit the content of trans fat, other than naturally occurring trans fat, in all foods to 2 grams per 100 gram fat. Following a Commission report published in 2015 on the potential mitigation measures for the overall reduction of trans fat intakes, it was considered a legal limit on industrial trans fats was the most effective means for the protection of consumer health. The report demonstrated that legal limits in the pioneer country Denmark had significantly lowered trans fats intake levels. The measure will override national initiatives which had been adopted or were in the make by various other EU Member States. The date of application of the ban is not yet known. It is currently notified as a technical barrier to trade allowing other countries to comment on the anticipated rules. The proposal however - provisionally - instigates that foods not complying with the new rules may be marketed until 1 April 2021.

EU Commission Proposal - COMMISSION REGULATION (EU) …/…of XXX amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards trans fat, other than trans fat naturally occurring in animal fat, in foods intended for the final consumer - link

DECEPTIVE QUALITY CLAIMS ADEQUATELY COVERED, COMMISSION ARGUES by Nikolaas Tilkin-Franssens

Following the report of the European consumer organization BEUC earlier in June, the Commission was asked a range of questions on whether it would take further initiatives in the field of food labelling. The BEUC report highlights food labelling practices to be considered misleading encouraging the European Commission to consider additional legislative measures or a stricter interpretation of the current rules. The questions were raised in the European Parliament to which Commissioner Andriukaitis has replied.

The first question related to whether the Commission had the intent to define the use of quality claims such as ‘natural’. ‘artisan’ and ‘natural’. In his reply Andriukaitis argued that quality terms are often linked to national practices and therefore should be addressed at member state level. A second practice brought forward in the report, is the display of fruit on the packaging while the food in reality barely contains any fruit. The Commission notes that EU legislation precludes misleading practices in general as well as specifically regarding the nature and quantity of food. Moreover, quantitative indication of ingredients is required where ingredients are emphasized by words or visually on the labelling. The application of these rules however lies with the Member States who are responsible to monitor compliance and interpret the rules in relation to the specific practices.

Consequently, the Commission asserts that current EU law is appropriate to deal with the alleged misleading practices and therefore it has no intention to adopt further rules or guidance.

Joint answer given by Mr Andriukaitis on behalf of the European Commission (Written questions: E-003659/18 , E-003973/18 , E-003879/18) - link

CONSEQUENCES OF BREXIT FOR FOOD LABELLING by Nikolaas Tilkin-Franssens

Following a range of guidance documents to prepare businesses for the actual Brexit in March 2019, UK authorities have provided a notice specifically addressing the repercussions for food labelling. The guidance leaves from the possibility that no arrangements would be made with the other EU member states,and thus EU law would no longer apply to the UK. Considering many of the EU rules, especially on compositional standards, are transposed into UK acts EU rules will largely remain applicable. As the UK will no longer be part of the European Union, the use of the term ‘EU’ will however no longer be of use for UK produce such as in the case of honey blends.

In addition, all products originating from other EU countries would need to include a UK address of a responsible food business operator. UK products on the other hand would require the inclusion of the address of a EU responsible operator in order to be legally marketed in the EU. Though the notice states that in consultation with UK retailers, a transitional measure may be considered and foods already placed on the UK market with the address of a EU responsible operator may be sold until exhaustion of available stocks. Furthermore, natural mineral waters originating from the UK will need recognition by another EU member state to maintain their status within the EU.

Guidance (24 September 2018) - Producing and labelling food if there's no Brexit deal - link

NEW ITALIAN “BELFRIT” DECREE PUBLISHED by Joris Geelen

The Italian authorities have published the highly anticipated decree on botanicals which integrates the so-called “BELFRIT” list, authorizing the use of more than 1000 plants and mushrooms in food supplements.

The decree includes a positive list of plants and mushrooms authorized for use in food supplements, together with mandatory warnings and maximum levels. Compared to Belgium, who published their version of the list last year, Italy has less restrictions, as shown in the following examples:

  • Contrary to Belgium and France, there are no maximum levels for anthranoid containing plants like Aloe or Rheum spp. (which are being disputed on EU level), Black cohosh, Hawthorn, Chamomile, Crocus, Devil's claw, Echinacea, Ginger, Hedera, Hops, Saw palmetto, Nettle, Valerian. Note that for most of them there is an EMA monograph;

  • Some plants do not have mandatory warnings as it is the case in Belgium e.g. Curcuma, Chaste tree, Verbena;

  • The decree authorizes stevia leaves, cannabis seeds and oil.

Besides this, and similar to France, the decree includes a list of information necessary for the correct and safe use of botanicals :

  • a clear definition of botanical preparation;

  • information and websites for the identification of plants; and

  • information on the preparation, the traditional use and the production process of the final product.

A separate decree on other substances establishes maximum levels for certain naturally occurring botanical substances with a physiological effect or of possible concern (for example EGCG and isoflavones).

As a transitional measure, foodstuffs that do not comply with the provisions of the new decree, but are compliant with the provisions of the former decree of 9 July 2012, can still be placed on the market until exhaustion of stocks.

Analysis

From the examples one could conclude that Italy takes a more liberal approach to risk management than Belgium. Where Belgium has a maximum limit for certain plants or substances of concern, Italy often resorts to less restrictive measures, mandatory warnings. On the other hand, in Italy there are no provisions exempting botanicals when these compounds have been removed or reduced to safe levels. Moreover, there are no official procedures for consulting the Italian Commission for Dietetics and Nutrition (CUDN), as is the case for the respective advisory commission in Belgium.

In our practice we help our clients to prepare the information necessary for the correct and safe use of botanicals, as part of a due diligence process. However, the authorities would most probably only ask for this information after a problem has arisen.

Overall, we remain positive about this decree. This harmonization together with the digital notification system has made the access to the European market more streamlined. 

Decree regulating the use of vegetable substances and preparations in food supplements, replacing the Decree of the Minister for Health of 9 July 2012

WHAT IF NO BREXIT DEAL IS REACHED? UK AUTHORITIES CLARIFY by Nikolaas Tilkin-Franssens

As 29 March 2019 is approaching, the day by which Brexit will become official, the UK authorities are considering all potential scenario’s. One of which is the risk that no deal is reached with the European Union political counterparts. The UK authorities emphasize that all effort is being put in coming to an agreement. Although, the authorities found it necessary to inform UK citizens and businesses what the impact would be of a no deal-scenario on the supply and trade of goods. Essentially, no agreement would mean the immediate end of free movement of goods and accordingly customs procedures will apply as is the case for third country imports and exports at present.

Besides a general consideration, also specific topics, including the cultivation of genetically modified organisms and the production of organic food, are addressed in individual Guidances. Regarding the use of GMO’s, no significant changes are to be expected in a no deal-scenario as the national implementing acts will remain valid in the UK. The text would be amended to relate to a national context only. This means that prior authorization of GMO’s will remain applicable. Current authorizations will remain valid and only over time, due to a different territorial scope of authorizations, divergences in may occur. For organic food and feed, the authorities intend to keep a comparable framework in place. There is the notable change that the EU organic logo will have to be replaced by a UK specific logo. Additionally, Organic exports to the EU will be dependent on European recognition of local certifying bodies. Applications for recognition can only start when the UK becomes officially a third country and applications take up to 9 months. However, it is made clear that in such case a transition measure or equivalency arrangement would be negotiated. The organic production legislation will initially remain in place and amended to a UK context. There are no plans to make any substantial changes to the current requirements and procedures.

Guidance on how to prepare if the UK leaves the EU with no deal - link

FRANCE RECOMMENDS TO LIMIT IODINE INTAKE FROM ALGAE by Nikolaas Tilkin-Franssens

The French Food Safety Authority, ANSES, advises to keep the intake of algae limited due to the presence of iodine. Nowadays algae have become increasingly popular for use in food and particularly food supplements which led the Authority to evaluate the potential excessive intake. Although data on the intake by the French population is not available to assess current exposure levels, the Authority based its assessment on parameters which currently limit the intake.

As a benchmark in the assessment, the French legal iodine limit of 150 micrograms in food supplements was considered together with the upper limit established by EFSA of 600 micrograms per day.  The French Authority found that the consumption of foods together with foods supplements that are both made from algae creates a considerable risk to exceeding the upper intake levels for iodine.

Especially people with thyroid disorder, heart disease or kidney failure, people taking iodine or lithium containing medication and pregnant or breastfeeding women are recommended to avoid consumption of algae-based food and food supplements, without seeking medical advice.

The use of algae food supplements is neither recommended for addressing iodine deficiencies.

AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif au risque d’excès d’apport en iode lié à la consommation d’algues dans les denrées alimentaires - link