Recent Developments Affecting EU Food Safety and Legislation

By Ralph Blanchfield

Introduction:

As with previous legislative reviews (see World of Food Science Archives), this review of some recent developments in EU food legislation and related matters is not intended to be complete in itself. While giving a brief outline “road-map” of the topics covered it also provides links to on-line references for full texts, to which the reader should refer for full information.

New Regulation on Provision of Food Information to Consumers

Regulation EU No 1169/2011 of the European Parliament and of the Council was published on 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004.

The following is a brief outline of some features, but the reader should refer to the full text of the Regulation at:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:304:0018:0063:EN:PDF   

This Regulation entered into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 13 December 2014, with the exception of point (l) of Article 9(1), which shall apply from 13 December 2016, and Part B of Annex VI, which shall apply from 1 January 2014.

It embodies many previous regulatory requirements but also some new definitions and new requirements. The Regulation comprises five Chapters:

• Chapter I General Provisions (Articles 1 and 2);
• Chapter II General Principles on Food Information (Articles 3 to 5);
• Chapter III General Food Information Requirements and Responsibilities of Food Business Operators (Articles 6 to 8);
• Chapter IV Mandatory Food Information (Articles 9 to 35);
• Chapter V Voluntary Food Information (Articles 36 and 37);
• Chapter VI National Measures (Articles 38 to 45);
• Chapter VII Implementing, Amending and Final Provisions (Articles 46 to 55).

In addition there are 15 Annexes.

     Articles 1 and 2 and Annex I provide definitions, including the new ones:

• “ 'Food information’ means information concerning a food and made available to the final consumer by means of a label, other accompanying material, or any other means including modern technology tools or verbal communication;”
• “ ‘Engineered nanomaterial’ means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.

Properties that are characteristic of the nanoscale include:

1. those related to the large specific surface area of the materials considered; and/or
2. specific physico-chemical properties that are different from those of the non-nanoform of the same material;”

Article 3 deals with general objectives, Article 4 deals with principles governing mandatory food information which are specified in much greater detail in Articles 9 to13, 17 to 20, 21 to 26 and ANNEX III. One new provision that may cause some difficulty with labels is in Article 12(2) and 12(3) which state:

"2. Without prejudice to specific Union provisions applicable to particular foods, when appearing on the package or on the label attached thereto, the mandatory particulars listed in Article 9(1) shall be printed on the package or on the label in such a way as to ensure clear legibility, in characters using a font size where the x-height, as defined in Annex IV, is equal to or greater than 1.2 mm.

"3. In case of packaging or containers the largest surface of which has an area of less than 80 cm2 , the x-height of the font size referred to in paragraph 2 shall be equal to or greater than 0.9 mm.”

However, it should be noted that Article 37 specifies that “Voluntary food information shall not be displayed to the detriment of the space available for mandatory food information.”. This may mean that on many labels space currently devoted to brand names, promotion and graphics may have to be minimised to make room for mandatory information in the font sizes specified.

Article 7 outlines fair information practices. Article 8 describes the responsibilities of business operators.

Article 19 lists foods not required to bear a list of ingredients.

Article 20 lists constituents of a food not required to be included in the list of ingredients.

Article 21 provides for more specific ways of indication of allergens (listed in Annex II) than in previous legislation.

Article 22 deals with quantitative indication required of certain ingredients (QUID).

Article 26 sets out rules relating to country of origin or place of provenance.

Articles 29 to 33 deal with nutrition information. The requirements are:

1. The mandatory nutrition declaration shall include the following:

            (a) energy value; and

            (b) the amounts of fat, saturates, carbohydrate, sugars, protein and salt.

Where appropriate, a statement indicating that the salt content is exclusively due to the presence of naturally occurring sodium may appear in close proximity to the nutrition declaration.

2. The content of the mandatory nutrition declaration referred to in paragraph 1 may be supplemented with an indication of the amounts of one or more of the following:

(a) mono-unsaturates;

(b) polyunsaturates;

(c) polyols;

(d) starch;

(e) fibre;

(f) any of the vitamins or minerals listed in point 1 of Part A of Annex XIII, and are present in significant amounts as defined in point 2  of Part A of Annex XIII.

3. Where the labelling of a prepacked food provides the mandatory nutrition declaration referred to in paragraph 1, the following information may be repeated thereon:

            (a) the energy value; or

            (b) the energy value together with the amounts of fat, saturates, sugars and salt.

4. By way of derogation from Article 36(1), where the labelling of the products referred to in Article 16(4) provides a nutrition declaration, the content of the declaration may be limited to the energy value only.

5. Without prejudice to Article 44 and by way of derogation from Article 36(1), where the labelling of the products referred to in Article 44(1) provides a nutrition declaration, the content of that declaration may be limited only to:

            (a) the energy value; or

            (b) the energy value together with the amounts of fat, saturates, sugars, and salt.

Stevia:

The European Commission published on 11 November 2011  the anticipated approval for the use of stevia as a sweetener in all Member States (by a curious anomaly it was already approved in France). This takes the form of Commission Regulation (EU) No 1131/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council with regard to steviol glycosides. It comes into force on 2 December 2011. Access via:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:295:0205:0211:EN:PDF

The Regulation contains no surprise features. Its Annex specifies the foods in which Stevia can be incorporated. In ingredients lists it must be described as “Sweetener steviol glycosides”.

New Union List of Food Additives Approved for Use in Food Additives, Food Enzymes, Food Flavourings and Nutrients

Simultaneously the European Commission has issued Commission Regulation (EU) No 1130/2011 of 11 November 2011 amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives by establishing a Union list of food additives approved for use in food additives, food enzymes, food flavourings and nutrients:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:295:0178:0204:EN:PDF

Development of Implementing Regulation for the Traceability Requirements Set by Regulation (EC) No 178/2002, for Foods of Animal Origin

Commission implementing Regulation (EU) No 931/2001 of 19 September 2011 provides for implementation of the traceability requirements set by Regulation (EC) No 178/2002 of the European Parliament and of the Council for food of animal origin. It is at:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:242:0002:0003:EN:PDF

It came into force in all Member States from 1 July 2012. Its key features are to require food business operators to ensure that the following information concerning consignments of food of animal origin is made available to the food business operator to whom the food is supplied and, upon request, to the competent authority:

(a) an accurate description of the food;

(b) the volume or quantity of the food;

(c) the name and address of the food business operator from which the food has been dispatched;

(d) the name and address of the consignor (owner) if different from the food business operator from which the food has been dispatched;

(e) the name and address of the food business operator to whom the food is dispatched;

(f) the name and address of the consignee (owner), if different from the food business operator to   whom the food is dispatched;

(g) a reference identifying the lot, batch or consignment, as appropriate; and

(h) the date of dispatch.  

Evaluation of European Union's Policy on Genetically Modified Organisms (GMOs)

Two independent reports published by the European Commission have found  broad support, from stakeholders and competent authorities alike, for the main objectives of the legislation, such as the protection of health and the environment and the creation of an internal market, as these objectives are consistent with the needs of society [but] note that the authorisation system could be more efficient, GMO cultivation would benefit from more flexibility and the risk assessment process from further harmonisation. Only limited changes to address specific issues are sufficient rather than an overall change to the system.

The 12 July 2010 Agra CEAS Consulting report, "Evaluation of the EU legislative framework in the field of GM food and feed" is at:

http://ec.europa.eu/food/food/biotechnology/evaluation/docs/evaluation_gm_report_en.pdf

The March 2011 European Policy Evaluation Consortium (EPEC) report "Evaluation of the EU legislative framework in the field of cultivation of GMOs under Directive 2001/18/EC and Regulation (EC) No 1829/2003, and the placing on the market of GMOs as or in products under Directive 2001/18/EC” is at:

http://ec.europa.eu/food/food/biotechnology/evaluation/docs/gmo_cultivation_report_en.pdf

The EU Commission’s response takes the form of "Questions and answers on the evaluation of the European Union's GMO legislation" and is at:

http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/11/742

Key points are that the Commission will propose in the coming weeks more precise requirements for the submission of authorisation applications for imported products for food and feed use, is also revising the guidelines on environmental risk assessment to make them more detailed and precise, and is already discussing them with Member States and stakeholders. Another priority aspect is the reinforcement of the monitoring of environmental effects by companies and by Member States.

European Court of Justice Ruling on Pollen in Honey:

In September 2011, the Court of Justice of the European Union (ECJ) gave its judgment on questions referred to it from a German court relating to the contamination of honey and pollen food supplements by genetically-modified organisms (GMOs). ‪The ECJ held that:

• Pollen found in honey or used to make food supplements is no longer a GMO if it is incapable of reproducing or of transferring genetic material.
• Nevertheless, the contaminated honey and food supplements would still come within the scope of the GMO Regulations and could not be placed on the market without an authorisation under Regulation (EC) No. 1829/2003.

Whereas foodstuffs containing honey were not previously required to declare the presence of GM pollen on their labels, this ruling means that honey containing traces of pollen from genetically modified (GM) plants must receive prior authorisation before it can be sold as food in the EU. This has significant implications not just for the producers of honey but also manufacturers who use honey as a natural sweetener and food supplement manufacturer which source honey from countries where GM crops are grown.

Safety of Pollen Produced by Genetically Modified Maize MON810

On 11 November 2011 the European Food Safety Authority issued a Statement of the EFSA GMO Panel "Statement on the safety of MON810 maize pollen occurring in or as food", viz: http://www.efsa.europa.eu/en/efsajournal/doc/2434.pdf

The summary reads:

Following the submission of a request from the European Commission received on 4 October 2011 the EFSA GMO Panel was asked to verify whether data provided within application RX-MON810 where sufficient to positively conclude on the safety of MON810 pollen as or in food and if this is the case to confirm its safety.

In delivering its scientific statement, the GMO Panel considered the data available on the safety of MON810 maize in application RX-MON810, as well as data available on maize pollen in general, and MON810 maize pollen in particular.

The molecular characterisation data established that maize MON810 expresses the Cry1Ab insecticidal protein under the control of enhanced 35S promoter from cauliflower mosaic virus and incorporates the maize Hsp70 intron. Bioinformatic analysis of the open reading frames spanning the junctions between the inserted DNA and maize genomic DNA did not raise safety concerns. The stability of the inserted DNA was confirmed over several generations, implying that the integrity of the insert was maintained throughout microsporogenesis and pollen production. Analyses of the levels of newly expressed proteins in various plant tissues did not raise safety concerns. Levels of Cry1Ab in pollen ranged from undetectable to 0.097 ?g/g fw, which is lower than levels observed in MON810 maize grain and forage.

With regards to the newly expressed Cry1Ab protein, the results of the molecular characterisation indicate that the same Cry1Ab protein is expressed in pollen as in other parts of the plant. Therefore the assessment and conclusions of the GMO Panel on safety of the protein Cry1Ab (including toxicity and allergenicity) reached for food/feed aspects also apply to pollen.

For maize MON810 grain and forage, the GMO Panel previously concluded, based on data from field trials as presented in application RX-MON810, that maize MON810 is compositionally, phenotypically and agronomically not different from the non-GM counterparts and conventional maize varieties, except for the new trait.

While limited data are available on the compositional and safety characteristics of maize pollen in general and in particular on those of MON810 maize pollen in comparison to non-GM maize pollen, the EFSA GMO Panel considered a range of additional data constituting a weight of evidence approach for the safety of MON810 maize pollen. These data consist of:

(1) the abovementioned molecular characterisation of MON810 maize;

(2) its extensive comparative data of agronomic, phenotypic and compositional characteristics, including reproductive traits related to pollen production and viability; and

(3) the food and feed safety of MON810 maize and the newly expressed Cry1Ab protein.

These data neither indicate potential concerns over the safety of the newly expressed Cry1Ab protein nor the occurrence of unintended effects that could raise safety concerns.

Maize MON810 is intended to be cultivated and used like any conventional maize which was the basis for a theoretical estimate of exposure of consumers to MON810 maize pollen through consumption of honey containing this pollen instead of pollen from non-GM maize. Since the level of exposure was found low, any unexpected, unintended effect of the genetic modification, if it occurred, would not be likely to result in an adverse health effect from honey consumption.

While the EFSA GMO Panel is not in a position to conclude on the safety of maize pollen in or as food in general, it concludes that the genetic modification in MON810 maize does not constitute an additional health risk if MON810 maize pollen were to replace maize pollen from non-GM maize in or as food.

EFSA Evaluation of Public Health Risk of Seeds and Sprouted Seeds in the EU

Following the outbreak in Germany, the European Food Safety Authority (EFSA) has "... evaluated the public health risk of Shiga-toxin producing Escherichia coli (STEC) and other pathogenic bacteria that may contaminate seeds intended for sprouting and sprouted seeds (sprouts, shoots and cress) ... [and] concludes that sprouted seeds are ready-to-eat foods with food safety concerns because certain pathogenic bacteria can contaminate seeds and grow during sprouting. Furthermore, preventing initial contamination during production, storage and distribution of seeds is of the foremost importance, as sprouted seeds have the potential to cause large foodborne outbreaks. Operators producing sprouted seeds should strive to implement additional food safety management measures across the whole sprout production chain. Stakeholders at all parts of the production chain and consumers, including also those practising home-sprouting, should be informed of the food safety risk posed by sprouted seeds”.

The Abstract and Summary of the EFSA Scientific Opinion is at:

http://www.efsa.europa.eu/en/efsajournal/pub/2424.htm and the full text is at http://www.efsa.europa.eu/en/efsajournal/doc/2424.pdf .

The European Commission Comprehensive Action Plan on Antimicrobial Resistance (AMR) in the EU

The European Commission has released a comprehensive Action Plan on Antimicrobial Resistance (AMR) containing 12 concrete actions to be implemented in close cooperation with the Member State for the next five years. The European Centre for Disease Prevention and Control (ECDC) has released "... new European-wide surveillance data showing that the percentage of carbapenem-resistant Klebsiella pneumoniae is increasing in the European Union. Several Member States are now reporting that between 15 percent and almost 50 percent of K. pneumoniae from bloodstream infections are resistant to carbapenems. Carbapenems are the major last-line class of antibiotics to treat infections with multidrug-resistant Gram-negative bacteria such as Klebsiella pneumoniae, a frequent cause of pneumonia and urinary tract infections in hospitals ...".

The 17 November 2011 European Commission Press Release, titled "Q&A: Antimicrobial Resistance", is at:

http://ec.europa.eu/food/animal/diseases/eradication/index_en.htm 

The "Communication from the Commission to the European Parliament and the Council Action plan against the rising threats from Antimicrobial Resistance" is at:

http://ec.europa.eu/dgs/health_consumer/docs/communication_amr_2011_748_en.pdf 

The 17 November 2011 European Centre for Disease Prevention and Control (ECDC) Press Release is posted at:

http://ecdc.europa.eu/en/press/Press%20Releases/1111-EAAD-2011.pdf  

The European Centre for Disease Prevention and Control (ECDC) "Antimicrobial resistance surveillance in Europe; Annual report of the European Antimicrobial Resistance Surveillance Network (EARS-Net) 2010" is at:

http://ecdc.europa.eu/en/publications/Publications/1111_SUR_AMR_data.pdf.pdf

Professor J Ralph Blanchfield MBE is a food science, food technology and food law consultant, a Fellow and Past President (2006-08) of the International Academy of Food Science and Technology, a Fellow and a Past President of the [UK] Institute of Food Science and Technology, a Fellow of the Institute of Food Technologists (IFT) and a member of the Editorial Advisory Board of The World of Food Science (e-mail: jralphb@easynet.co.uk)