Food Safety/Risk Management/Nutrition Security/Foods for specific groups/Food which is outside the scope of Regulation (EU) No 609/2013 and therefore without specific legislation.
Access subdetails Foods for specific groups

Food which is outside the scope of Regulation (EU) No 609/2013 and therefore without specific legislation.

 

  1. Meal replacements for weight control
  2. Food intended for diabetics
  3. Young child formulae
  4. Food for people with gluten intolerance
  5. Food for people with lactose intolerance and galactosaemia
  6. Food intended for sportspeople
  7. Formulae for preterm newborns

 


Meal replacements for weight control

The indication «meal replacements for weight control», or similar expressions, will fall within the scope of Regulation (EC) No 1924/2006 of the European Parliament and of the Council, of 20 December 2006, on nutrition and health claims made on food and must satisfy the conditions of use established in the same, the publication of the amendment of Regulation (EU) No 432/2012, establishing a list of permitted health claims made on food, other than those referring to the reduction of disease risk and to children's development and health, and including two new claims relative to the indication «meal replacement for weight control», or similar expressions, is still pending adoption.

The proposed text was approved in the Standing Committee of Plants, Animals, Food and Feed General Food Law Section held on 12 April 2016, and currently continues with the Comitology procedure with control.

Consequently, until the date of implementation of the modification of the above regulation, Royal Decree 1430/1998, of 15 September 1997 continues in force, on food products intended to be used in low calorie diets for weight control.


Food intended for diabetics

In a report from the Commission to the European Parliament and the Council, of 26 June 2008, on food for persons suffering from carbohydrate metabolism disorders (diabetes) it was concluded that there is no scientific base for establishing specific compositional requirements for food intended for this population group, as they are able to satisfy their nutritional requirements by adapting their diet and consuming food intended for everyday consumption.

Report from the Commission to the European Parliament and the Council on foods for persons suffering from carbohydrate metabolism disorders (Diabetes) Brussels, 26.6.2008 COM(2008) 392 final

These products are no longer considered as food intended for particular nutritional purposes, therefore from 20 July 2016, date of implementation of Regulation (EU) No 609/2013, the horizontal legislation must be met. Nevertheless, they may remain in the market until the stocks are exhausted, given that a 3-year transition period has already passed.


Young child formulae 

There are an increasing number of milk-based drinks and other similar products in the European Union market which are promoted as particularly suited for young children. These products, which may be derived from animal or plant proteins, including cow's milk, goat's milk, soy or rice, are placed on the market as «growing-up milk», or «milk for young children», or similar terminology.

These products are currently regulated by different legal acts of European law, including Regulations (EC) No 178/2002, (EC) No 1924/2006 and (EC) No 1925/2006, and Directive 2009/39/EC, and are not covered by the current specific measures applicable to food intended for infants and young children.

The Commission, after consultation with the European Food Health Authority, on 31 March 2016 published their report to the European parliament and the Council on growing-up milks or, as the EFSA recommends they be called, “young child formulae”. The report concludes that the general food law is adequate for regulating these young children formulae and, therefore, they are outside the scope of Regulation (EC) No 609/2013.

These products are no longer considered as food intended for particular nutritional purposes, therefore from 20 July 2016, date of implementation of Regulation (EU) No 609/2013, the horizontal legislation must be met.

EFSA opinion

Commission Report to the European Parliament and the Council on young child formulae (SWD (2016) 99 final)

COMMISSION STAFF WORKING DOCUMENT Young-child formulae: background information


Foodstuffs suitable for people intolerant of gluten

Foodstuffs suitable for people intolerant to gluten are regulated by Commission Regulation (EC) No 41/2009 of 20 January, up to 20 July 2016.

With the adoption of Regulation (EU) No 609/2013 it was decided that the indications for the provision of information to consumers on the absence or reduced presence of gluten in food are within the scope of Regulation (UE) No 1169/2011 of the European parliament and of the Council, of 25 October 2011, on the provision of food information to consumers, adopting Commission Implementing Regulation (EU) No 828/2014 of 30 June, on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food, which is applicable from 20 July 2016, and they are no longer considered as food intended for a particular nutritional purpose.

In conclusion, these products are no longer considered as food intended for particular nutritional purposes, and shall comply with the horizontal legislation and the requirements for the provision of information to consumers on the absence or presence of gluten in the food established in Implementing Regulation (EU) No 828/2014.

Nevertheless, those products which comply with the previous Regulation (EC) 41/2009 may remain in the market until stocks are exhausted.


Food for people with lactose intolerance and galactosaemia

On the same lines, it is considered that the use of indications of the absence or reduced presence of lactose in food must be made in accordance with Regulation (EU) No 1169/2011, as there are no harmonised laws at European Union level on labelling and composition. It is expected that specific legislation regulating these indications is to be drafted, as in the case of the indications relating to the absence or reduced presence of gluten in food, considering the scientific ruling of the European Food Safety Authority, of 10 September 2010, on lactose thresholds in lactose intolerance and galactosaemia.

Until said legislation is drafted, the criteria established jointly by the Spanish Agency for Consumer Affairs, Food and Nutrition and the Regional Communities will be applicable.

Explanatory note

Scientific Ruling of the European Food Safety Authority, of 10 September 2010, on lactose thresholds in lactose intolerance and galactosaemia


Food intended for sportspeople

Also known as food suitable for the expenditure of intense muscular effort.

On 15 June 2016, the Commission presented to the European Parliament and the Council its report on food intended for sportspeople. This report concludes that there is no need for specific provisions for food for sportspeople. From 20 July 2016 these products shall satisfy the horizontal laws belonging to the EU food law.

Commission Report to the European Parliament and the Council on food intended for sportspeople (published on 15 June 2016).

Report of the Scientific Committee on Food on composition and specification of food intended to meet the expenditure of intense muscular effort, especially for sportspeople (Adopted by the SCF on 22/6/2000, corrected by the SCF on 28/2/2001)

Scientific and technical assistance on food intended for sportspeople (Published by the EFSA on 29 September 2015)


Formulae for preterm newborns

In practice, the nutritional requirements of preterm or low birth weight infants depend on the condition of health of the infant and in particular the weight in comparison with healthy infants, together with the number of weeks of prematurity of the infant.

Therefore, in accordance with the recommendations of the World Health Organisation (WHO), low birth weight infants should be fed with breast milk. If this is not possible, infant formulae satisfy the nutritional requirements of low birth weight infants, regulated by Royal Decree 867/2008, of 23 May, approving the specific Technical and Health Regulations for infant formulae and follow-on formulae.

However, preterm and low birth weight infants may have special nutritional requirements that cannot be satisfied with breast milk or infant formulae, and their condition of health may require that they consume, under medical supervision, food for special medical purposes developed to satisfy the nutritional requirements of the infants and adapted for the dietary management of the specific health condition of the infant, regulated by Royal Decree 1091/2000, of 9 June, approving the specific Technical and Health Regulation on dietary food intended for special medical purposes or Delegated Regulation (EU) 2016/128, on the compositional and information requirements for food for specific medical purposes. See table summarising the transition periods for Food for special medical purposes in this document.