The special dietary use pre-packaged food labels (GB13432-2013) question and answer (revised edition) 

The 2014-09-02 national health and population and family planning commission of the People's Republic of China
A, on special diets with food
 
Special meals with food is to point to to meet the special physical or physiological condition and (or) meet disease, disorder and other conditions of special dietary requirements, special processing or formula food, mainly including infant formula food, infant food, special medical use formula, and other special meals with food. Appropriate crowd of this kind of food, nutrients, and (or) other nutrients content request has the certain particularity, the label content such as energy and nutrients, edible method, appropriate crowd signs have special requirements, etc.
 
Second, the special dietary use pre-packaged food label revised goal and background
 
"Food safety", China issued the "general principles for prepackaged food labels (GB7718-2011) and the general rules of pre-packaged food nutrition labels (GB28050-2011), and other basic food safety standards, and the infant formula (GB10765-2010), the larger infants and young children formula (GB10767-2010), the general principles for special medical purposes infant formula (GB25596-2010), the general principles of the special medical use formula (GB29922-2013), and other special meals with food product standards. To ensure that the special diet with food labelling standards with the current special meals with food product standards and related standards, according to the food safety law and the measures for the administration of the national food safety standards, by organization revised the original "the general principles for special dietary use pre-packaged food labels (GB13432-2004, hereinafter referred to as GB13432-2004), released a new" special dietary use pre-packaged food label "(GB13432-2013, hereinafter referred to as GB13432-2013) will come into force as of July 1, 2015.
 
Three, the applied range of this standard
 
GB13432-2013 is suitable for special dietary use pre-packaged food labels, including nutrition labels. Standard covers for special dietary use pre-packaged food labels general requirements, such as product name, ingredients, production date, shelf life, etc., as well as nutrition labeling requirements, including nutrition claims table, nutrient content claims and function. Standard has been clear about the special diet with the definition and classification of food products that meet the definition and classification of the label should comply with the provisions of this standard.
 
Original GB13432-2004 listed in categories such as "sugar free instant soybean powder, such as" iron fortified high-protein instant soybean powder belongs to what you did to ordinary food nutrition claims, shall comply with the general principles for prepackaged food labels (GB7718-2011) and the general rules of pre-packaged food nutrition labels (GB28050-2011) regulation, does not apply to this standard.
 
Four, with the relevant standards, how to join
 
General principles for the pre-packaged food labels (GB7718-2011) stipulates the pre-packaged food (including special dietary food) label basic labeling requirements. Special dietary use pre-packaged food labels (GB13432-2013) provides for special dietary use food labels are special identification requirements. Special dietary use pre-packaged food labels shall be implemented according to the and GB13432 GB7718-2011-2011. To meet the requirements of the GB13432-2013 content claimed special dietary use pre-packaged food, if on energy and (or) nutrition function, claimed that its function claims that language should choose the general rules of pre-packaged food nutrition labels (GB28050-2011) claims that the standard terms specified in the function.
 
Five, the principle of standard revision
 
Standard revision follow the following principles: one is the original "the general principles for special dietary use pre-packaged food labels (GB13432-2004) was the basis of the implementation, according to the actual special dietary use food industry development in our country, combining with the public demand for special dietary use food label revised standard, raise the scientific nature of the standard and the label health implications. Second, pay attention to with the laws, regulations and other foods and label standard cohesion and form a complete set, to ensure the consistency and stability of the policy. Three is the management experience of international organizations and other countries for reference, perfect the special dietary use food standard label requirements, meet the consumers' right to know and options, convenient for special dietary use the international trade of food.
 
Six, the standard revision of the main process
 
In accordance with the "food safety" and "national food safety standards management method" regulation, follow the principle of consultation, process open and transparent, standard eventually research the present situation of our country special dietary use food labels, organize seminars and expert consultation meeting for many times, fully listen to the relevant government departments, scientific research institutions, industry associations and so on various aspects the opinion, according to the program to solicit opinions from the public and notified to the wto members, according to the feedback and improve the standard text review opinions. The draft standard after the first session of the evaluation committee for national food safety standards, director of the eighth meeting review.
 
Seven, with special dietary food labelling standards abroad
 
International organizations and many countries are rules for special dietary use food labels. International codex alimentarius commission (CAC) has established the special dietary use pre-packaged food labels and claims that the general standard "(CEDEX STAN 146), also food for special medical purposes alone made the special medical use food labels and claimed that the standard" (CEDEX STAN, 180). The United States, the European Union, Australia, New Zealand and many other countries and regions for special dietary use food labels have relevant regulation.
 
Eight, the main content of the standard revision
 
GB13432 compared with GB13432-2004-2013, the main revision of the following:
 
1. Modify the definition of special dietary use food, clear its food categories, contains has been clear about the standard applicable scope.
 
2. With reference to international standards, increase should not 0 to 6 months infant formula claims that the essential ingredients in content and function of claims to the basic requirements.
 
3. Modify the energy and nutrition labeling method and the permissible error scope and other requirements.
 
4. Merge the allow labeled content and recommend it.
 
5. Modify the energy and nutrient content claims claims that language requirement and function, and according to international practice, delete the energy and nutrients is claimed.
 
Nine, about should not be involved in disease prevention, treatment, function, etc
 
"Food safety law" specific provision: food, food additives, label, instruction shall not be involved in disease prevention and treatment function. Special dietary use food as a category of food, although its product formula design with clear target, but its purpose is to provide nutritional support for the target population, have no disease prevention, treatment, and other functions, thus GB13432-2013 definitely require special dietary use food labels should not be involved in disease prevention and treatment function.
 
Ten, of energy and nutrients
 
Is a special dietary energy and nutrients in the food and ordinary food difference, is the main feature of the content of labeling is a special meal with one of the most important part of food labels. Special meals with food energy and nutrients content should conform to the requirements of the corresponding product standards, and shall truthfully labeled on the label.
 
Infant formula, for example, except in the product label should be labeled energy, protein, fat, carbohydrates and sodium content, should also be labeled "infant formula" (GB10765-2010) of the content of essential ingredients. If the infant formula products on the basis of GB10765-2010 or the food nutrition fortifier USES standard (GB14880-2012) as well as health and family planning commission and/or the ministry of health related announcement, add the optional ingredients or strengthened the certain substances, should also be labeled these components and their content.
 
GB10765-2010 in the footnote part and nutrient ratio requirements (such as linoleic acid and the ratio of alpha linolenic acid, calcium, phosphorus ratio, milk whey protein content in infant formula, the proportion of the amount of lauric acid and nutmeg acid fat accounted for the proportion of the total fatty acids, lactose or proportion of the total carbohydrate, etc.) does not require the mandatory labeling, enterprises can choose whether to sign voluntarily.
 
GB13432-2013 of energy and nutrition labeling, the name of the sequence, units and repair about interval should not be forced, enterprises should in the reference standards on the basis of the factual and objective.
 
11, about the nutritional information energy and nutrition labeling way
 
GB13432-2013 revision process, eventually carried out market research, considering the domestic product label actual situation, draw lessons from the international practice, only allowed to use "specific numerical" marked in the form of energy and nutrients content, and allowed error is less than 80% of the labeled value, and meets the requirement of the corresponding product standards. No longer use the original GB13432-2004 "value", "low or high" label.
 
Twelve, trans fatty acids is mandatory
 
The infant formula (GB10765-2010) and other special dietary use clear requirements should not be used in food product standards hydrogenated oils and trans fats limited, the above products shall implement the product standard. GB13432-2013 does not require the mandatory labeling of trans fatty acids content, enterprises can choose whether to sign voluntarily.
 
13, about the energy and nutrient content claims
 
GB13432-2013 revision process, reference international management experience and according to the product characteristics determine the demand of energy and nutrient content claims. Features of the product according to the needs of product standards, such as the general principles for special medical purposes infant formula (GB25596-2010) specified in the "lactose-free formula", "low lactose formula", etc., shall comply with the requirements of the relevant product standards.
 
As nutrient composition in the product standard, the food nutrition fortifier USES standard (GB14880-2012) and no minimum requirements relevant statement or no minimum amount of reinforcement, other countries and international organizations (or) should be provided to allow for the special dietary nutrients in foods for content is the basis of a claim, and shall comply with the regulations of the conditions and requirements. In some countries special dietary use food labels to use but no clear regulations on the basis of the content of claim as a reference.
 
To guide enterprise labeled correctly, the following were collected at home and abroad about the content of special dietary use food claims requirements, claim terms and regulations basis (table 1).
 
Table 1. Allows the use of the content of claims
 
nutrients
Content of claim terms
Content requirements
Can use the product category
 
Docosahexaenoic acid (DHA)
contains
0.2% of the total fatty acid content or higher
Infant formula
 
Special medical use of infant formula
 
taurine
contains
Acuity 0.8 mg / 100 kj
Infant formula
 
Special medical use of infant formula
 
Low poly galactose
 
Low poly fructose
 
Polymers of fructose
 
raffinose
Include the name of dietary fiber or monomer
The monomer or the content of the mixture
 
3 g / 100 g or higher (solid or powder),
 
Acuity 1.5 g/mL (liquid) or 100
 
Acuity 1.5 g / 420 kJ
Infant formula foods
 
Infant cereal food aid
 
 
Note: the above claim terms synonym: provide, source, ham, and there are.
 
Reference:
 
1. com MISSION DIRECTIVE 2006/141 / EC of 22 another awarding 2006 on infant formulae and follow - on formulae and amending DIRECTIVE 1999/21 / EC, Annex Ⅳ: 1. NUTRITION CLAIMS. (the eu DIRECTIVE 2006/141 / EC, infant formula and larger infant formula, the appendix 4:1. NUTRITION CLAIMS)
 
2. The FOOD Standard Australia, New Zealand, Standard 2.9.1 Infant Formula Products, Division 1: Permitted nutritive substances. (Standard 2.9.1 anz, Infant Formula, the first part: 7. Allow nutrients)
 
3. The general rules of pre-packaged food nutrition labels (GB28050-2011) appendix C.
 
14, claimed that comparison of energy and nutrients
 
Special meals with food for different applicable objects have different formula, its energy and nutrients content have clear requirements in the product standard, it is not necessary to set up more claims, therefore GB13432-2013 is not set rules.
 
15, about the function of the energy and nutrition claims
 
According to the international management experience, and links up, nutrition labeling standard GB13432-2013 regulations to meet the requirements of this standard content claim function of nutrients can be claimed, and should choose "general rules of pre-packaged food nutrition labels (GB28050-2011) states the function of standard language. For not listed GB28050-2011 in the function of the claims, other countries and international organizations (or) should be provided to allow for special dietary use function claims that the language used in the food and the basis, and shall comply with the regulations of the conditions and requirements. In some countries special dietary use food labels to use but no clear rules and regulations according to the function of the claim as a reference.
 
To guide enterprise labeled correctly, the following were collected at home and abroad to allow for special dietary use food function claims and basis (table 2).
 
Table 2. Allows the use of the function of the claim
 
nutrients
Function claims that language
Content requirements
Can use the product category
 
Docosahexaenoic acid (DHA)
Docosahexaenoic acid (DHA) help baby vision of normal development.
0.3% of the total fatty acid content or higher
Larger infant formula
 
Low poly galactose
 
Low poly fructose
 
Polymers of fructose
 
raffinose
1, dietary fiber, helps maintain normal bowel function.
 
2, dietary fiber is low energy substance.
The monomer or the content of the mixture
 
3 g / 100 g or higher (solid or powder), acuity 1.5 g/mL (liquid) or 100
 
Acuity 1.5 g / 420 kJ
Infant formula foods
 
Infant cereal food aid
 
Poly (glucose
1, dietary fiber, helps maintain normal bowel function.
 
2, dietary fiber is low energy substance.
To allow to strengthen the lowest
Infant formula foods
 
Yeast beta glucan
1, dietary fiber, helps maintain normal bowel function.
 
2, dietary fiber is low energy substance.
To allow to strengthen the lowest
Infant formula
 
 
Reference:
 
1. com mission Regulation (EU) No 440/2011 of May 6, 2011 on the authorisation and refusal of authorisation of certain health claims made on foods and referring to the children 's development and health, ANNEX I: Permitted health claims. (EU Regulation No 440/2011, involved in the approval and refused to ratify the food of child development and health health claims, appendix 1: allow health claims)
 
2. The general rules of pre-packaged food nutrition labels (GB28050-2011) appendix D.
 
16, about 0 to 6 months infant formula claimed a necessary component of the content of claims and function
 
Our national food safety standards to the 0 to 6 months infant formula value have specific provision, content of essential ingredients in infant formula must conform to the requirements of the standard content. Due to the 0 to 6 months of age babies need comprehensive and balanced nutrition, should not claim that its essential ingredients. The regulations and international standards of the codex alimentarius commission (CAC) and most of the relevant provisions of the state.
 
On the 17th and special medical use formula (including special medical use infant formula) formula describes the characteristics and nutritional characteristics
 
Because of the special medical use formula and special medical use of infant formula products, there is a special formula and the target population, this kind of product requirements in the product label on product formula describes characteristics and nutritional characteristics, facilitate clinical guidelines and use. This description does not belong to the function of energy and nutrient content claims or claims, shall refer to the corresponding provisions of product standards, should be factual and objective and not misleading.
 
Eighteen, about how provided by proteins or amino acids hydrolysate protein label
 
When special medical use formula, special medicine, use the protein in infant formula is provided by the hydrolyzed protein and/or amino acid, such as the depth of the milk protein hydrolysate formula or amino acid formula, the product does not contain or contain small amounts of protein, so "protein" available "protein", "protein (equivalent)" or "total amino acids" any kind of way. GB13432-2013 is not mandatory labeling formulations of types and content of amino acids.
 
19, about to eat it
 
Special dietary use food labels should be labeled method, daily, or every meal intake, to guide the rational use of consumers. Among them, the special medical use formula (including special medical use infant formula) method needs to be a doctor or a clinical nutritionist according to the individual consumer or medical condition, and adjust the stages of such products of edible method can be labeled "daily consumption or meal with reference to the doctor or the guidance of clinical nutritionist" or similar terms.
 
Twenty, about the implementation of the standard date
 
This standard will be in July 1, 2015 formally implemented, the implementation date to allow and encourage enterprises engaged in food production or marketing executive GB13432-2013; After the implementation of this standard, the enterprise shall be in strict accordance with the standard regulations. Prior to the date of implementation of the production of food, can continue to sell within the food shelf life until the end of shelf life.