New (novel) foods — rules from 2018

Regulation (EU) 2015/2283 on novel foods

It lays down rules for the placing of novel foods* on the market in the European Union (EU). These are designed to provide a high level of protection for human health and consumers’ interest.

KEY POINTS

Food business must determine whether the product they wish to place on the market is covered by the legislation. If they are unsure:
they may consult the national authorities of the market concerned by providing all the necessary information;
those national authorities may consult colleagues in other EU countries and the European Commission.

The Commission must establish a positive list of authorised novel foods by 1 January 2018 and update it regularly.An authorised product must not:
pose a risk to human health, on the basis of scientific evidence;
mislead consumers, especially when it is intended to replace another food and there is a significant change in nutritional value;
be nutritionally disadvantageous when replacing another food under normal consumption.

The authorisation procedure for the placing of a novel food on the market can be triggered either by an applicant (EU country, a non-EU country or an interested party) or by the Commission.
The application must include details, such as the name and description of the novel food, its detailed composition, production processes and scientific evidence, confirming that it does not pose any danger to human health.

The Commission may ask the European Food Safety Authority to give its opinion on the safety of the novel food.
The Commission presents its final opinion on whether to authorise a novel food to the Standing Committee on Plants, Animals, Food and Feed. Its endorsement is necessary before the new product can be added to the positive list.
Specific rules apply to traditional foods from non-EU countries which their food business operators or importers wish to sell in the EU.

The legislation does not apply to:
genetically modified foods covered by Regulation (EC) No 1829/2003;
foods used as enzymes, additives and flavourings covered by Regulations (EC) No 1332/2008, (EC) No 1333/2008, (EC) No 1334/2008;
extraction solvents within the scope of Directive 2009/32/EC.

DOCUMENTS

Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, pp. 1-22)It applies from 1 January 2018.

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 (OJ L 351, 30.12.2017, pp. 55-63)

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 (OJ L 351, 30.12.2017, pp. 64-71)

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 (OJ L 351, 30.12.2017, pp. 72-201)

Food flavourings

Regulation (EC) No 1334/2008 on flavourings for use in and on foods

It lays down the general requirements for the safe use of flavourings* in food.
It also includes, for example, certain labelling requirements that must be respected.
It contains, in an annex, a list of approved flavourings.

KEY POINTS

Flavourings must not pose a safety risk to consumers (on the basis of the scientific evidence available), and not mislead them.
The regulation defines what are, for example, flavourings, flavouring substances, flavouring preparations, smoke flavourings, thermal process flavourings, flavour precursors, and food ingredients with flavourings properties.

This legislation does not apply to substances with only an exclusively sweet (e.g. sugar), salty (e.g. salt) or sour taste, or to raw foods or mixtures such as fresh, dried or frozen spices and/or herbs, or to teas and infusions. Substances providing a sweet taste are sweeteners which constitute a specific category of food additives.
It also lays down which types of flavourings need to undergo an evaluation and approval process and which ones do not.

The EU adopted a list of approved flavouring substances on 1 October 2012. Only these flavouring substances may be used in and on foods and sold in the EU. The list is updated periodically.
The regulation also contains a list of 15 naturally occurring substances of toxicological concern. These include estragol, menthofuran, methyleugenol, hydrocyanic acid and coumarin and may not be added to food as such. Maximum levels are set for the presence of certain of these naturally occurring substances in foods.They may be present, such as as certain traditional foods or certain alcoholic and non-alcoholic drinks.

As regards labelling, flavourings sold from business to business or to the general public have to comply with specific rules in addition to the requirements in Regulation (EU) No 1169/2011 on providing food information to consumers on labelling. The specific rules for the labelling of flavourings in and on foods relate to both regulations when sold to the general public and from business to business.

The term ‘natural’ to describe a flavouring may only be used for substances derived directly from animal or vegetable material.
Food business operators (flavouring producers, or importers or users of flavourings like the food industry) must report to the European Commission on the amounts they have added to foods over a 12-month period, if so requested.

A producer or user of a flavouring must inform the Commission of any scientific or technical information which is known and accessible to them and which might affect the assessment of the safety of the flavouring.

It has applied since 20 January 2011.

DOCUMENTS

Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, pp. 34-50)

Successive amendments and changes to the Annexes of Regulation (EC) No 1334/2008 have been incorporated in the original text. This consolidated version is of documentary value only.

Commission Implementing Regulation (EU) No 1321/2013 of 10 December 2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings (OJ L 333, 12.12.2013, pp. 54–67)

Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC (OJ L 267, 2.10.2012, pp. 1-161)

Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 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 (OJ L 304, 22.11.2011, pp. 18–63)

Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (OJ L 309, 26.11.2003, pp. 1–8)

Use of enzymes in foods (excluding those in additives)

Regulation (EC) No 1332/2008 on food enzymes

—It lays down harmonised rules for enzymes* used in food. These rules are necessary to protect human health and to enable the enzymes to be added anywhere in the EU.
—The legislation contains an EU list of approved enzymes, conditions for their use in food, and labelling requirements.

The regulation, which amends earlier legislation, entered into force on 20 January 2009.

KEY POINTS

—Only enzymes on the EU list may be sold and used in food.
— Approved enzymes must not be dangerous to human health, nor mislead consumers. They must respond to a reasonable technological need in the manufacture, processing, preparation, treatment, packaging, transport or storage process.
— The approved list contains details of the enzyme’s name and other relevant information, the foods to which it can be added, conditions of use and any restrictions or specific requirements.
— Specific labelling rules apply to enzymes, depending on whether they are intended for sale to the public or not.
— The information must be easily visible, clearly legible, indelible and understandable.

ACTS

Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97 (OJ L 354, 31.12.2008, pp. 7–15)

Authorisation procedure for additives, enzymes and flavourings

The European Commission is to lay down a common, effective, fast and transparent procedure for the authorisation of food additives, food enzymes and food flavourings in the Community. This procedure is based on a risk assessment by the European Food Safety Authority (EFSA). It leads to the establishment, management and updating of a Community list for each of the three categories of substances.

Common authorisation procedure for food additives, food enzymes and food flavourings.

Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings.

The Regulation lays down a common procedure for the assessment and common authorisation of food additives, enzymes and food flavourings. This procedure facilitates the free movement of food while guaranteeing the health and welfare of consumers.

The common procedure lays down the arrangements for drawing up and updating the Community lists for each category of substances. Only substances included in these lists are authorised on the Community market.

Main stages of the common procedure

The common procedure for updating the Community list may be started either on the initiative of the Commission or following an application by a Member State or an interested party. Applications shall be sent to the Commission.

The Commission shall forward the applications to the European Food Safety Authority (EFSA) for risk assessment. The EFSA shall give its opinion within nine months of receipt of the application. That period may be extended if the Authority requests additional information from the applicant.

The common procedure shall end with the adoption by the Commission of a Regulation updating the list of substances within nine months of receipt of the EFSA’s opinion. That period may be extended if the Commission requests additional information concerning aspects of risk management. The new period shall be determined together with the applicant.

The Commission may end the common procedure at any time, irrespective of the stage it has reached. In this case, it shall inform the applicant and the Member States if necessary, stating the reasons for its decision.

Implementing measures

The Commission shall adopt the implementing measures for this Regulation within two years from the adoption of the sectoral food law (the Regulations on additives, on enzymes and on flavourings).

Six months after the entry into force of each sectoral food law, the EFSA shall present a proposal to the Commission concerning the data required for risk assessment of the substances concerned with a view to the adoption of the implementing measures of this Regulation.

Transparency

The EFSA shall ensure the transparency of its activities by making public its opinions and any extensions of periods for the provision of additional information.

Confidentiality

The manufacturer shall indicate which information is confidential when the application is submitted. The Commission shall then determine which information in the application for authorisation is confidential and shall notify the applicant accordingly. After being made aware of the Commission’s opinion on the confidential aspects, the applicant may withdraw its application so as to preserve that confidentiality if it does not agree with that opinion.

The following information shall not, in any circumstances, be regarded as confidential:

the name and address of the applicant;
the name and description of the substance;
the justification for the use of the substance;
the information concerning the safety of the substances;
where applicable, the analysis method.

Emergencies

If an emergency is connected with one of the substances on the authorised lists, the Commission shall initiate the procedures relating to food safety.

Comitology

The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health for the updating of the list of additives, enzymes and flavourings.

List of competent authorities

Six months after the entry into force of each sectoral food law, Member States shall forward to the Commission the name and address of the national competent authority and a contact point.

Context

This Regulation meets the objectives laid down in the 2000 White Paper on Food Safety, in which the Commission announced its intention to update and supplement the existing legislation on additives and flavourings and to establish specific provisions on enzymes.

In parallel, the Commission has developed three other proposals for Regulations which make the placing of these substances on the Community market subject to compliance with harmonised criteria and the granting of an authorisation:

Regulation (EC) No 1332/2008 on food enzymes;
Regulation (EC) No 1333/2008 on food additives;
Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods.
This sectoral food legislation shall be supplemented by the establishment of a common authorisation procedure to harmonise the differing national authorisation procedures which may hinder the free movement of the substances and lead to unfair competition.

References

Regulation (EC) No 1331/2008

Maximum levels for certain contaminants in food

To ensure high levels of public health, in this law, the European Union sets maximum levels for certain contaminants in food. Contaminants are substances that have not been intentionally added to food but have arrived in it in the course of its production, packaging, transport, etc.

Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs.

It lays down the maximum limits for certain contaminants in food in particular to protect the health of the most sensitive population groups, i.e. children, the elderly and pregnant women.

Scope

The following contaminants are covered:

mycotoxins (aflatoxins, ochratoxin A, fusarium toxins, patulin and citrinin),
metals (lead, cadmium, mercury, inorganic tin),
3-monochloropropane-1,2-diol (3-MCPD),
dioxins and dioxin-type polychlorinated biphenyls (PCBs),
polycyclic aromatic hydrocarbons (PAHs),
melamine,
erucic acid,
nitrates.

Limits

Food with levels of contaminants higher than those specified in the annex to the law may not be sold. These limits cover the edible part of food and also apply to compound or processed, dried or diluted foods.

The regulation also lays down the lowest maximum levels for contaminants reasonably achievable with good manufacturing practices or good agricultural practices (ALARA, ‘as low as reasonably achievable’).

Ban on mixing

Foods complying with the maximum limits may not be mixed with other foods which exceed these limits.
Foods which must be sorted or subjected to other physical treatments to reduce the level of contamination may not be mixed with foods complying with the maximum limits.

Labelling

Labelling on groundnuts, other oilseeds, nuts, dried fruit, rice and maize sold as foods which have to be subjected to sorting or other physical treatment before human consumption must include the wording ‘Product shall be subjected to sorting or other physical treatment to reduce aflatoxin contamination before human consumption or use as an ingredient in foodstuffs’.

Labelling on groundnuts, other oilseeds, products derived from oilseeds and cereals must indicate the use and lot identification code.

Exceptions

Certain EU countries may exceed the levels of dioxins and PCBs for certain fish and fish products originating from the Baltic and intended for consumption in their territory. Their labelling must warn of the potential risks to consumer health.

Testing

EU countries must test the levels of nitrates in vegetables likely to contain significant levels (particularly those with green leaves). Their results must be sent to the European Food Safety Authority (EFSA).

REFERENCES

Regulation (EC) No 1881/2006

Regulation (EC) No 1126/2007

Regulation (EC) No 629/2008

Regulation (EC) No 165/2010

Regulation (EU) No 420/2011

Regulation (EU) No 1258/2011

Regulation (EU) No 1259/2011

Regulation (EU) No 594/2012

Regulation (EU) No 1058/2012

Regulation (EU) No 1067/2013

Regulation (EU) No 212/2014

Regulation (EU) No 362/2014

Regulation (EU) No 488/2014

The successive amendments and corrections to Regulation (EC) No 1881/2006 have been incorporated in the original text. This consolidated version is of documentary value only.

Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, pp. 1-3).

Foods for special medical purposes

Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No 609/2013 — the specific compositional and information requirements for food for special medical purposes.It applies from 20 July 2016, except for Article 11 (compositional and information requirements), Article 16 (updating the EU list), Article 18 (delegated acts) and Article 19 (urgency procedure), all of which apply from 19 July 2013.

It modifies labelling requirements for foods for special medical purposes, and introduces a ban on making nutrition and health claims for such foods.
It extends the rules for infant and follow-on formula on labelling, presentation, advertising and marketing to cover foods for special medical purposes intended for infants.
It also extends the rules on pesticides to foods for special medical purposes intended for infants and young children.

The directive repeals Directive 1999/21/EC. It is a delegated act that supplements Regulation (EU) No 609/2013 on foods for specific groups.

Food for special medical purposes:

may only be placed on the market if it complies with this regulation;
falls within 3 categories:
nutritionally complete food with a standard nutrient formulation, which could constitute the sole source of nourishment, or be used as a partial replacement or supplement;
nutritionally complete food with a nutrient-adapted formulation specific for a disease, disorder or medical condition, which could constitute the sole source of nourishment, or be used as a partial replacement or supplement;
nutritionally incomplete food which is not suitable to be used as the sole source of nourishment.

Pesticides

Food for special medical purposes developed for infants and young children must not contain pesticide residues exceeding 0.01 mg/kg per active substance.

Food information labelling

Food for special medical purposes must comply with Regulation (EU) No 1169/2011 on the labelling of foodstuffs and these statements or warnings (the first 4 points preceded by the words ‘important notice’ or equivalent) must appear on labelling:

product must be used under medical supervision;
whether the product is suitable for use as the sole source of nourishment;
whether the product is intended for a specific age group;
whether the product poses a health hazard for persons who do not have the condition for which the product is intended;
the statement ‘For the dietary management of (the disease, disorder or medical condition for which the product is intended)’;
precautions and contra-indications;
a description of what makes the product useful in relation to the disease, disorder or medical condition, relating to the special processing and formulation, the nutrients and the product rationale;
warning that the product is only to be taken by mouth;
instructions for the preparation, use and storage of the product after opening.

Nutritional declaration

The mandatory nutrition declaration, with some specific exceptions, must include the amount (where appropriate) of minerals, vitamins, protein (including its source and nature), carbohydrate, fat and other nutrients and their components.
Nutrition and health claims must not be made on food for special medical purposes.

Specific requirements for food for special medical purposes developed for infants

Mandatory information must be in a language easily understood by the consumers.
Labelling must not include pictures of infants, or other pictures or text which may idealise the use of the product, with the exception of graphics for easy identification or illustrating preparation methods.

Labelling must be designed so that consumers can make a clear distinction between such products and infant formula.
Advertising must be restricted to publications specialising in baby care and scientific publications.
There must be no point-of-sale advertising, free samples or any other promotional device directly to the consumer at the retail level.

Manufacturers and distributors must not directly provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts.
Food business operators must notify the competent authority of each EU country, where the product is being placed on the market, by sending a model of the label used for the product, and any other information requested to establish compliance with this regulation.

It has applied since 22 February 2019, except in respect of food for special medical purposes developed for infants, for which it applies from 22 February 2020.

DOCUMENT

Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes (OJ L 25, 2.2.2016, pp. 30-43)

Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, pp. 35-56)

Successive amendments to Regulation (EU) No 609/2013 have been incorporated into the original document. This consolidated version is of documentary value only.

Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 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 (OJ L 304, 22.11.2011, pp. 18-63)

Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, pp. 71-86)

Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, pp. 1-33)

Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006, pp. 9-25)

Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (Codified version) (OJ L 339, 6.12.2006, pp. 16-35)

Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, pp. 29-36)

Foods for specific groups

Regulation (EU) No 609/2013 — foods for infants, young children and special medical purposes, as well as total diet replacement for weight control

It seeks to ensure better consumer protection in respect of the content and marketing of foods for infants, young children and special medical purposes, as well as of total diet replacement for weight control.
It also seeks to provide greater legal certainty for businesses operating in the sector and for national authorities applying the rules.

KEY POINTS

Regulation (EU) No 609/2013 replaces a plethora of rules that had built up over 3 decades and become both complex and fragmented.

The new law strengthens provisions on foods for vulnerable population groups that need particular protection, such as infants and children up to 3 years old, overweight or obese people and people with specific medical conditions, e.g. people with metabolism disorders.

The current 3 lists of substances (including minerals and vitamins) that can be added to these foods have been replaced by a single list.

The regulation also delegates responsibility to the European Commission to adopt, by means of delegated acts, specific compositional and labelling rules for the following categories of foods:

infant and follow-on formulae;
processed cereal-based foods and other baby foods;
for special medical purposes; and
total diet replacement for weight control.

In the future, gluten-free and very low gluten foods will be governed by Regulation (EU) No 1169/2011 on the provision of food information to consumers. Commission Implementing Regulation (EU) No 828/2014 ensures the transfer of these rules to that regulation and is applicable as of 20 July 2016.

Likewise, by means of a further delegated act, the Commission is to transfer rules that regulate meal replacement for weight control to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods.

The Commission is also required to prepare reports on:

milk-based drinks (so called ‘growing-up milks’) and similar products intended for young children so as to analyse the necessity to establish special compositional and labelling rules for this kind of product;
food intended for sportspeople so as to analyse the need to draw up special compositional and labelling rules.
If the Commission decides that specialist legislation is not required for these foods, they would be expected to then be covered by general food legislation, namely Regulation (EC) No 1924/2006 on nutrition and health claims made on foods.

In addition, the Commission will examine how to ensure that gluten-intolerant people are adequately informed of the difference between food that is specially produced, prepared and/or processed to reduce the gluten content by at least one gluten-containing ingredient and food that is made exclusively from naturally gluten-free ingredients.

ACTS

Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, pp. 35-56)

Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006, pp. 9-25). Successive amendments to Regulation (EC) No 1924/2006 have been incorporated into the basic text. This consolidated version is for reference only.

Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 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 (OJ L 304, 22.11.2011, pp. 18-63). See consolidated version.

Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food (OJ L 228, 31.7.2014, pp. 5-8)

Infant and follow-on formula — composition and information

Regulation (EU) 2016/127 supplementing Regulation (EU) No 609/2013 as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding

It supplements Regulation (EU) No 609/2013 on foods for specific groups, which requires the European Commission to adopt composition and labelling rules for infant formula* and follow-on formula*, through a delegated act, and based on the latest scientific advice.
It bans nutritional and health claims on infant formula to protect and encourage breast-feeding.
It helps national authorities to better monitor the infant formula market through additional notification rules.

KEY POINTS

Directive 2006/141/EC is repealed from 22 February 2020 but will continue to apply until 21 February 2021 to infant formula and follow-on formula manufactured from protein hydrolysates.

Infant formula or follow-on formula not manufactured entirely from cows’ milk or goats’ milk proteins must carry the official names prescribed in each EU language. In English they are respectively ‘Infant formula’ and ‘Follow-on formula’.

Ingredients

Infant formula and follow-on formula must:

comply with this regulation, and with other relevant horizontal rules of EU food law, including Regulation (EU) No 1169/2011 on providing food information to consumers;
follow the compositional requirements of the regulation that are applicable to products ready for use marketed as such or to products ready for use after preparation as instructed by the manufacturers;
require nothing more than the addition of water if marketed as ready for use or ready after preparation in accordance with the manufacturer’s instructions;
be manufactured from protein sources as set out in the regulation and other food ingredients, whose suitability for infants from birth (for infant formula) or for infants aged over six months (for follow-on formula) is established by generally accepted scientific data;
not contain pesticide residues exceeding 0.01 mg/kg per active substance, with certain exceptions;
not be made from agricultural products using pesticides containing the banned substances listed in the regulation, subject to a maximum residue value for the purposes of checking;
No product other than infant formula may be marketed or represented as suitable to satisfy the nutritional requirements of normal healthy infants during the first months of life.

Food information

Formula must comply with Regulation (EU) No 1169/2011 on providing food information to consumers, with the following additional information:

a statement that the product is suitable for infants from birth when they are not breast fed (infant formula only);
an ‘Important Notice’ (also included in advertising) about the superiority of breast feeding and a statement recommending that the product be used only on professional advice (infant formula only);
a statement that the product is suitable only for infants over 6 months, only as part of a diversified diet, not to be used as a substitute for breast milk during the first 6 months and that the decision to begin complementary feeding should be made only on professional advice based on the individual infant’s specific growth and development needs (follow-on formula only);
instructions for a preparation, storage and disposal of the product and a warning against the health hazards of inappropriate preparation and storage.
The labelling, presentation and advertising of infant formula and follow-on formula must provide the necessary information about the appropriate use of the products. This is so as not to discourage breast feeding, and the information provided must avoid any risk of confusion between infant formula and follow-on formula.

In addition to the information referred to in Regulation (EU) No 1169/2011, the mandatory nutrition declaration for infant formula and follow-on formula must include the amount of each mineral substance and of each vitamin listed in annexes to this regulation respectively and present in the product, with the exception of molybdenum and the amount of salt.

The mandatory nutrition declaration may be supplemented with the amounts of components of protein, carbohydrate or fat and the whey protein/casein ratio, and other substances listed in the annexes to this regulation or Regulation (EU) No 609/2013.

Nutrition and health claims must not be made on infant formula.

The statement ‘lactose only’ may only be used where lactose is the only carbohydrate present in the product. The statement ‘lactose free’ is for use only where the lactose content is not greater than 2.5 mg/100 kJ (10 mg/100 kcal).

When the statement ‘lactose free’ is used for formula manufactured from protein sources other than soya protein isolates, it must be accompanied by the statement ‘not suitable for infants with galactosaemia*’. The statement ‘contains Docosahexaenoic acid (DHA)*’ or ‘contains DHA’ (as required by the legislation for all infant formula) may only be used for infant formula placed on the market before 22 February 2025.

Advertising and promotion

Advertising of infant formula, which must contain only information of a scientific and factual nature, is restricted to publications specialising in baby care and scientific publications. EU countries can apply stricter rules such as banning such advertising, Advertising must not imply or create a belief that bottle-feeding is equivalent or superior to breast feeding.

There must be no point-of-sale advertising, free samples or any other promotional device to induce sales of infant formula directly to the consumer.

Feeding information

EU countries must ensure that objective information is provided on infant and young child feeding. Informational and educational materials must include clear information on the following:

the benefits and superiority of breast feeding;
maternal nutrition and the preparation for and maintenance of breast feeding;
the possible negative effect on breast feeding of introducing partial bottle feeding;
the difficulty of reversing the decision not to breast feed;
where needed, the proper use of infant formula.
Such information must include the social and financial implications of the use of infant formula, the health hazards of inappropriate foods or feeding methods, and the health hazards of improper use of infant formula. It must not contain any pictures which could idealise the use of infant formula.

Notification

When infant formula is placed on the market, the food business operator’s requirement to notify national authorities of the launch of new products is extended to follow-on formulae, and must include submitting a model of the label used and all relevant information considered necessary to demonstrate compliance with the regulation.

DOCUMENT

Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (OJ L 25, 2.2.2016, pp. 1-29)

Successive amendments to Regulation (EU) 2016/127 have been incorporated into the original text. This consolidated version is of documentary value only.

Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, pp. 35-56)

Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 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 (OJ L 304, 22.11.2011, pp. 18-63)

Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006, pp. 9-25)

Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, pp. 1-33)

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, pp. 1-24)

EU standards for natural mineral waters

Directive 2009/54/EC — exploitation and marketing of natural mineral waters

It harmonises the conditions under which natural mineral waters may be sold in the EU and ensures these are safe for human consumption.It applies from 16 July 2009.

KEY POINTS

National authorities must ensure the water complies with the EU legislation before they award it natural mineral water status. Each EU country informs the European Commission when this recognition is granted or withdrawn.

Natural mineral water imported into the EU must be certified and satisfy the same criteria as domestic competitors.
Natural mineral water may not undergo any treatment apart, for instance, from the separation of unstable elements such as iron and sulphur compounds.
At source, and when on sale, natural mineral waters must be free from parasites, various coliforms (types of bacteria) and other ingredients dangerous to human health.
Containers for natural mineral waters must be properly sealed to avoid any possible contamination.

Natural mineral waters may be sold, where appropriate, according to the following definitions:
natural mineral water
carbonated* natural mineral water
naturally carbonated* natural mineral water
natural mineral water fortified with gas from the spring.

Labels must also give the following information:
details of the water’s analytical composition
the name and place of the spring used
information on any treatment the water has undergone.

It is illegal to use more than one trade description to market natural mineral water from the same spring.
It is illegal to claim that the water has characteristics it does not possess.
The term ‘spring water’ can only be used for water intended for human consumption in its natural state, bottled at source and meets the legislation’s health and labelling conditions.
A national authority which considers that a natural mineral water could be a danger to human health may restrict or ban its sale. It informs other EU countries and the Commission.
The legislation does not apply to waters considered to be medicinal products or to natural mineral waters used as cures in thermal and hydrothermal spas.

ACT

Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural mineral waters (Recast) (OJ L 164, 26.6.2009, pp. 45-58)

Marketing of seed potatoes

Directive 2002/56/EC on the marketing of seed potatoes

It aims to maintain high standards of health and varietal purity in seed potatoes on the EU market.

It does this:

by regulating initial propagating material, the length of the generational chain, packaging and labelling, and
by applying strict tolerances for diseases.

KEY POINTS

EU countries can market only seed potatoes fulfilling the criteria in this directive. Seed potatoes are officially certified as basic seed potatoes* or certified seed potatoes* satisfying minimum conditions for each category during plant inspections, but potatoes that are not themselves rejected in this process can be re-sorted for further inspection.

Non-commercial trade in seed potatoes, such as supplying official testing bodies is not considered as marketing.

Seed potatoes on the market should:

meet minimum quality conditions (see below);
not be treated with sprout inhibitors;
have a minimum size such that they do not pass through a square mesh of 25 × 25 mm;
not vary in size, within a lot, beyond a set formula;
be marketed only in clean, new, tamper-proof packages which must be sealed with a sealing device (less stringent rules apply to small deliveries direct to end-consumers);
have an official label on the packaging, white for ‘basic’ and blue for ‘certified’, with a similarly coloured official document enclosed;
be appropriately labelled if genetically modified.

EU countries can subdivide the categories of seed potatoes into grades for different requirements.

Small quantities of seed potatoes for scientific purposes or selection work, or other test or trial purposes may be authorised. In the case of genetically modified material, authorisation is granted only if all appropriate measures have been taken to avoid adverse effects on human health and the environment.

Minimum quality conditions

Implementing Directive 2013/63/EU amends and strengthens the original minimum conditions to be satisfied by seed potatoes. They are designated ‘basic’ (or ‘certified’) if they are from plants where no more than:

1 in 100 ‘basic’ (1 in 25 ‘certified’) are affected by blackleg;
1 in 1000 (1 in 200) do not breed true to variety or are of a different variety, or 1 in 400 (1 in 200) of their direct progeny;
1 in 25 (1 in 10) of the direct progeny have symptoms of virus infection, caused by viruses that are prevalent in Europe; and
1 in 125 (6 in 100) have mosaic or leaf roll virus symptoms, caused by viruses that are prevalent in Europe.
There should be no more than 4 generations of basic potatoes and 2 generations of certified seed potatoes.

The regulation stipulates specific limits for certain impurities, blemishes and diseases allowed in seed potato lots, including earth and extraneous matter: not to exceed 1% (2% for ‘certified’). Other tolerances, such as for rot, blemishes and scab must not exceed a total of 6% among basic seed potatoes (8% if ‘certified’).

EU countries may apply more stringent quality conditions than those outlined in this directive.

Information required on labels

EU rules and standards
certification authority and EU country
official serial number
producer’s ID number or lot number
month and year of sealing
variety
country of production
category and, if desirable, grade
size
weight.
Labels must be a minimum size of 110 x 67 mm.

BACKGROUND

It has applied since 9 August 2002. Revised minimum quality conditions have applied since 7 January 2014 and had to become law in the EU countries by 31 December 2015.

This directive codifies Council Directive 66/403/EEC.

DOCUMENT

Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes (OJ L 193, 20.7.2002, pp. 60-73)

Successive amendments to Directive 2002/56/EC have been incorporated in the original text. This consolidated version is for documentary purposes only.

Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (OJ L 193, 20.7.2002, pp. 1-11)

Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 169, 10.7.2000, pp. 1-112)

Smoke flavourings — safety assessment

Regulation (EC) No 2065/2003 — smoke flavourings for foods

It sets EU-wide rules on authorising and using smoke flavourings in foods.

KEY POINTS

The regulation introduces a safety assessment and authorisation procedure for primary smoke condensates* and primary tar fractions* which can be used in and on foods and/or for the production of derived smoke flavourings*.

The primary products* for which no health concern is expressed during evaluation are then included in a list of authorised products under specific conditions of use.

Authorisations are granted for a period of 10 years after which they have to be renewed. This ensures that products are regularly re-assessed in the light of the latest scientific and technical knowledge and that authorised products, that are no longer used, are removed from the EU’s positive list.

Applicants for the authorisation of a primary product must provide detailed information on:

the type of wood used for the production of the primary product;
detailed information on the production methods of the primary products and the further processing in the production of derived smoke flavourings;
the intended uses in or on specific foods or food categories;
chemical specifications;
toxicological studies; and
validated methods for sampling and detecting primary products and derived smoke flavourings.

The safety evaluation of the applications is carried out by the European Food Safety Authority (EFSA) according to a specific time-frame and on the basis of transparent procedures.

The application is made to EFSA, the Commission and the EU countries. If requested by the applicant, certain sensitive data may remain confidential.

The EFSA assessments on smoke flavourings are available here: EU lists of flavourings – Scientific advice – 3 Smoke flavourings (primary products)

Commission Regulation (EC) No 627/2006 establishes quality criteria for the validated analytical methods for sampling, identification and characterisation of primary smoke products, as referred to in Annex II of Regulation (EC) No 2065/2003.

It has applied since 16 December 2003 apart from its Article 4(2) prohibiting the placing on the market of a smoke flavouring or food in or on which smoke flavouring is present if the flavouring has not been authorised, which has applied since 16 June 2005.

DOCUMENT

Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (OJ L 309, 26.11.2003, pp. 1-8)

Successive amendments to Regulation (EC) No 2065/2003 have been incorporated into the original document. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Commission Implementing Regulation (EU) No 1321/2013 of 10 December 2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings (OJ L 333, 12.12.2013, p. 54-67)

Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, pp. 34-50)

Commission Regulation (EC) No 627/2006 of 21 April 2006 implementing Regulation (EC) No 2065/2003 of the European Parliament and of the Council as regards quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products (OJ L 109, 22.4.2006, pp. 3-6)

Reducing the presence of acrylamide in food

SUMMARY OF:

Regulation (EU) 2017/2158 — mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food

It aims to reduce the level of acrylamide* in food.

It does so by requiring manufacturers, fast-food chains and restaurants, collectively known as food business operators, to follow certain procedures.

These ‘mitigation measures’ are designed to ensure acrylamide levels for different foods are below the indicative benchmarks set out in the legislation.

KEY POINTS

The procedures:

are based on current scientific and technical knowledge;
vary depending on the size of the food operator — they are more onerous for large-scale businesses.
Food business operators must:

apply the mitigation measures set out in the regulation’s annexes;
sample and analyse the food they produce;
consider whether changes to their production processes are necessary.
The measures apply to:

selection, storage and transport of raw ingredients;
recipes and design processes;
information to the public.
The products covered by the legislation are:

French fries, other cut deep-fried products, and sliced potato crisps from fresh potatoes;
potato crisps, snacks, crackers and other potato products from potato dough;
bread;
fine bakery items such as cookies, biscuits, rusks, cereal bars, scones, cornets, wafers, crumpets, gingerbread, crackers and crisp breads;
coffee (roast and instant) and coffee substitutes;
baby food and processed cereal-based food for infants and young children.

The European Commission will:

consider setting maximum acrylamide levels for certain foods;
review the benchmark levels in the regulation every 3 years. The first time will be in 2021.

BACKGROUND

Acrylamide is a carcinogenic substance that forms naturally when food, especially potato- or cereal-based products, coffee and coffee substitutes, is fried, roasted or baked at temperatures above 120°C.

The European Food Safety Authority confirmed in 2015 that acrylamide potentially increases the risk of developing cancer.

The regulation is in line with the principle established in Regulation (EC) No 852/2004 on hygiene of foodstuff that the food we eat must meet high levels of consumer protection.

For more information see:

Acrylamide: vote in favour of Commission’s proposal to reduce presence in food — press release (European Commission)
Acrylamide (European Food Safety Authority).

DOCUMENT

Commission Regulation (EU) 2017/2158 of 20 November 2017 establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food (OJ L 304, 21.11.2017, pp. 24-44)It applies from 11 April 2018.

Commission Recommendation 2013/647/EU of 8 November 2013 on investigations into the levels of acrylamide in food (OJ L 301, 12.11.2013, pp. 15-17)

Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, pp. 1-54). Text republished in corrigendum (OJ L 226, 25.6.2004, pp. 3-21)

Successive amendments to Regulation (EC) No 852/2004 have been incorporated in the original text. This consolidated version is of documentary value only.

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, pp. 1-24)

Using alumina to remove fluoride from mineral waters

Regulation (EU) No 115/2010 — use of activated alumina for fluoride removal from mineral waters

It sets out rules for the use of activated alumina* to remove fluoride* from mineral and spring waters, to comply with EU directives on the quality of drinking water.

KEY POINTS

The use of activated alumina to remove fluoride in natural mineral waters and spring waters is permitted, under the following conditions:

The release of residues into the water as a result of the treatment must be as low as technically possible and not be a risk to public health.
The use of the treatment must be notified to the competent authorities at least 3 months in advance, with documentation and data to show that it complies with the regulation.

All chemicals used in the treatment must comply with standards applicable to the treatment of drinking water.
The activated alumina must comply with European standards to ensure that no excess residues are released into the water.
Before use, the activated alumina must be treated to remove residues and fine particles.
Filters must be rinsed as a final step to ensure that they do not affect the mineral content of the treated water.

The activated alumina must be regenerated at appropriate intervals to restore its effectiveness.
The operator must monitor processes to ensure that the essential characteristics of the water are maintained.
The use of a fluoride removal treatment should be indicated on the label of treated water, close to the composition list, in the form: ‘water subjected to an authorised adsorption technique’.

BACKGROUND

Directive 2009/54/EC sets out the EU’s rules on the permitted methods for treatment of natural mineral waters and spring waters. It authorises the European Commission to lay down the conditions for use of treatments following consultation with the European Food Safety Authority.It has applied since 2 March 2010.

Commission Directive 2003/40/EC sets a limit for fluoride in natural mineral waters. The limit for spring water is fixed by Council Directive 98/83/EC.
Chemical processing is subject to the good manufacturing practices and the principles set out in Regulation (EC) No 852/2004 of the European Parliament and of the Council on food hygiene.
For more information, see:
Natural Mineral Waters and Spring Water (European Commission).

KEY TERMS

Activated alumina: highly porous form of aluminium oxide with a large surface area. It can be used as a filter to remove fluoride from drinking water.
Fluoride: a naturally occurring element in water supplies. Concentrations vary widely from one EU country to another.
MAIN DOCUMENT

Commission Regulation (EU) No 115/2010 of 9 February 2010 laying down the conditions for use of activated alumina for the removal of fluoride from natural mineral waters and spring waters (OJ L 37, 10.2.2010, pp. 13–15)

Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural mineral waters (Recast) (OJ L 164, 26.6.2009, pp. 45–58)

Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, pp. 1–54). Text published in corrigendum (OJ L 226, 25.6.2004, pp. 3-21).

Successive amendments to Regulation (EC) No 852/2004 have been incorporated into the basic text. This consolidated version is of documentary value only.

Commission Directive 2003/40/EC of 16 May 2003 establishing the list, concentration limits and labelling requirements for the constituents of natural mineral waters and the conditions for using ozone-enriched air for the treatment of natural mineral waters and spring waters (OJ L 126, 22.5.2003, pp. 34–39)

Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, pp. 32–54)

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