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US Food Legislation News March 2014

Posted by Alice Zhao

Mar 24, 2014 10:05:21 AM

icon-b    SCC_CloudSelerant-Compliance-Cloud

 

Pesticides residues in food, new tolerances from EPA

March 19, 2014: Since February 12, 2014; the Environmental Protection Agency (EPA) has released new pesticides tolerances for the following substances:

Alkyl Alcohol Alkoxylate Phosphate and Sulfate Derivatives; (40 CFR 180.910/930) link 

Fluxapyroxad; (40 CFR 180.666) link                               

N-(n-octyl)-2-pyrrolidone; (40 CFR 180.1130)  link

GS-omega/kappa-Hxtx-Hv1a; (40 CFR 180.1324)  link        

Fluopicolide; (40 CFR 180.627) link                                       

Triflumizole; (40 CFR 180.476) link     

Metconazole; (40 CFR 180.617) link

Fenamidone; (40 CFR 180) link

Ipconazol. (40 CFR 180) link 

 

New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File

March 17, 2014; The Food and Drug Administration (FDA) is amending its regulation regarding the confidentiality of data and information in and about new animal drug application files to change the time when certain approval-related information contained in the NADA file will be publicly disclosed. FDA would then be able to update the Green Book within its 30-day statutory timeframe. Consequently, FDA said scrapping the requirement to publish the information in the federal register first will allow it to speed up the release of information, similar to how information is now released for human pharmaceutical products. It will also permit more timely public disclosure of approval-related information, increasing the transparency of FDA decision making in the approval of new animal drugs.

More information: New Animal Drug Applications (21 CFR 514)

 

FDA Reopens Comment Period on Draft Industry Guidance on Evaporated Cane Juice as a Food-Labeling Term

March 4, 2014; The Food and Drug Administration formally reopened the comment period for draft guidance for industry on declaring "evaporated cane juice" as an ingredient on food labels published on October 7, 2009. The agency originally published and accepted comments on the guidance in fall 2009. The scope is to obtain additional data and information to better understand the basic nature and characterizing properties of the ingredient, the methods of producing it, and the differences between this ingredient and other sweeteners.

The draft guidance informed industry that sweeteners derived from cane syrup should not be listed on food labels as evaporated cane juice because the sweetener is not juice as juice is defined by Federal regulations, Title 21 of the Code of Federal Regulations, Section 120.1(a).

Interested parties may submit comments by written letter or electronically before May 5, 2014.

Additional information, including directions for filing comments and the final due date for comments, is available in the Federal Register notice announcing reopening of the comment period.

 

Revisions to Special Supplemental Nutrition Program for Women, Infants and Children (WIC) Food Packages.

March 4, 2014; The final rule considers public comments submitted in response to the interim rule revising the WIC food packages published on December 6, 2007.

The interim rule revised regulations governing the WIC food packages to align them more closely with Dietary Guidelines for Americans and infant feeding practice guidelines of the American Academy of Pediatrics, promote and support more effectively the establishment of successful long-term breastfeeding, provide WIC participants with a wider variety of food, and provide WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences.

The modifications in the final rule reflect the experiences of WIC State agencies in implementing the interim rule, while continuing to fulfill the intent of the recommendations of the Institute of Medicine (IOM) of the National Academies that serve as the basis for the WIC food package changes. These changes include yogurt as a partial substitute for milk and more whole grain and fish options for women and children as well as additional fruits and vegetables for children.

The final rule is designed to improve the nutrition and health of the nation’s low-income pregnant women, new mothers, infants and young children by providing more healthy choices to meet their needs during critical periods of growth and development.  

On 20th of March the table 3 of this final rule is corrected, for more information visit the following website:

https://www.federalregister.gov/articles/2014/03/20/C3-2014-04105/special-supplemental-nutrition-program-for-women-infants-and-children-wic-revisions-in-the-wic-food

Useful links:

Special Supplemental Nutrition Program for Women, Infants and Children (WIC) Final Rule: Revisions in the WIC Food Packages

USDA Finalizes Changes to the WIC Food Packages

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Topics: pesticide residues, veterinary drug residues, United States, nutrition

Codex March 2014 Food Legislation News

Posted by Elisa Servida

Mar 24, 2014 9:53:50 AM

SCC_CloudSelerant-Compliance-Cloud

Codex Committee on Contaminants in foods

During the 8th Session of the CCCF that will be held March 31 – April 4 in The Hague, Netherlands, the committee, among other matters, will discuss:

  • Proposed draft maximum levels for Deoxynivalenol  (at Step 7) and Acetylated Derivatives (DON) (at Step 4) in cereals and cereal-based products

  • Proposed draft maximum levels for Fumonisins in maize and maize products and associated sampling plans (at Step 4)

  • Discussion paper on the establishment of a maximum level for total Aflatoxins in ready-to-eat peanuts and an associated sampling plan

  • Discussion paper on the development of a Code of Practice for the Prevention and Reduction of Arsenic Contamination in Rice

  • Discussion paper on the possible revision of the Code of Practice for Prevention and Reduction of Mycotoxin Contamination in Cereals

  • Discussion paper on Aflatoxins in cereals

  • Discussion paper on the review of the guideline levels for Methylmercury in fish and predatory fish

    For the agenda click here

In Washington, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS), the Food and Drug Administration (FDA), have sponsored a public meeting to provide information, receive public comments on agenda items and draft U.S. positions to be discussed at the 8th Session of the Codex Committee on Contaminants in Food (CCCF).

Read more here

 

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Topics: contaminants, Codex Alimentarius

Asia Food Legislation News March 2014

Posted by Annie He

Mar 24, 2014 9:53:03 AM

china_flag SCC_Cloud Selerant-Compliance-Cloud

 

China

 

NHFPC released Q&A of "Pathogen limits in food" (GB29921-2013)

GB29921 applies to pre-packaged foods. GB29921 set up Pathogens limits for 11 food categories which include meat, aquatic products, ready to eat egg products, cereal products, ready to eat soy products, chocolates and cocoa products, ready to eat fruit and vegetable products, beverages, frozen drinks, ready to eat spices, nut and seed. GB29921 sets up Pathogen limits for 5 kinds of bacteria which includes Salmonella, Listeria monocytogenes bacteria, Escherichia coli O157: H7, Staphylococcus aureus and Vibrio parahaemolyticus.

Non-prepackaged food manufacturers and distributors shall strictly control the production process and health management, to minimize the risk of pathogen contamination.

Canned food should meet the requirements of Commercial sterilization and does not apply to this standard.

http://www.nhfpc.gov.cn/sps/s3594/201403/db2dc26b9938424cb8ecc52463a90792.shtml

 

NHFPC released draft version of “Planning project of National food safety standards integration (2014 -2015)” and “2014 national food safety standard project plan”

National Health and Family Planning Commission released the draft plan and is asking for stakeholders’ comments.

http://www.nhfpc.gov.cn/sps/s3593/201403/9273f2053aba489eaae1773de35a4c4f.shtml

 

"General rules for the labeling of prepackaged food" (GB7718-2011) Q & A (revised edition) and "General rules for the nutrition labeling of prepackaged food" (GB 28050-2011) Q&A (revised edition)

National Health and Family Planning Commission released the revised version of "General rules for the labeling of prepackaged food" (GB7718-2011) Q&A and "General rules for the nutrition labeling of prepackaged food" (GB 28050-2011) Q&A.

http://www.nhfpc.gov.cn/sps/s3594/201402/544c0539b95d4d35b99ffbc105579071.shtml

http://www.nhfpc.gov.cn/sps/s3594/201402/6f68ec6692594cf28d190cb47b770c11.shtml

 

EU updates list of imports of plant origin subject to reinforced border checks

Controls performed at European Union borders on the basis of Regulation (EC) No 669/2009 continue to deliver results and, as a consequence, the EU is removing some products from the list of feed and food of non-animal origin that are subject to an increased level of official controls by national competent authorities at the border. As a result of the satisfactory results reported by Member States, dried noodles from China will be de-listed from the Regulation's Annex I. This means that these products will no longer be subject to the reinforced scheme (the checks performed by competent authorities will again be 'routine' ones).

http://ec.europa.eu/food/food/controls/increased_checks/index_en.htm

 

GB 9685-2008 Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials

GB 9685-2008 specifies principles for use of additives in food containers and packaging materials and lists 959 permitted additives as well as their scope of use, maximum level, specific migration limit or maximum permitted quantity and other restrictive requirements.

In addition to GB 9685-2008, NHFPC released the following three batches of additives for use in food packaging materials in China: 

MOH Announcement No.23-2011: 107 resins used in food packaging materials

MOH Announcement No. 5-2012:  301 additives used in food packaging materials

MOH Announcement No.5-2013:  258 additives used in food packaging materials

http://www.nhfpc.gov.cn/zwgkzt/psp/200905/40795.shtml

 

TAIWAN

"food allergen labeling regulations” will take effect on 1 July 2015 [Release Date :2014-03-07]

Prepackaged food which contains the following allergens, should have significant warning and label the allergen contents in its container or package.

(A) shrimp and its products. (B) Crab and its products. (C) mango and its products. (D) peanut and its products. (E) Milk and its products; lactitol (lactitol) which made from milk is exempted. (F) egg and its products.

http://www.fda.gov.tw/TC/newsContent.aspx?id=10855&chk=040b9ea7-c513-4930-ae37-6b0fe595c49d&param=pn%3d1%26cid%3d3%26cchk%3d46552e96-810a-42c3-83e1-bd5e42344633#.Ux6DavmSzY8

 

"labeling requirements on dairy products" [Release Date :2014-02-19]

The labeling rule provides definitions of terms used in commercially packaged dairy products such as "milk, preserved milk, flavored milk, preserved flavored mil, milk drinks, preserved milk drink, milk powder, flavored milk powder" and specifies that if the product meets the definition and not using those specified terms in the name of the product, the terms should be labeled by a significant mark on the product packaging.

http://www.fda.gov.tw/TC/newsContent.aspx?id=10807&chk=22477e4a-8417-46b7-9578-5d7e304e75d4&param=pn%3d3%26cid%3d3%26cchk%3d46552e96-810a-42c3-83e1-bd5e42344633#.Ux6MC_mSzY8

 

Amendment to "Labeling requirements prepackaged beverages which declare containing fruit and vegetable juices" [Release Date :2014-03-04] 

Amendment is made to the "Labeling requirements prepackaged beverages which declare containing fruit and vegetable juices".

Beverages which label declares fruit/vegetable juice and containing two or more kind of fruits and vegetables should meet following requirements: (1) Beverages which disclose the name of all the fruits and vegetables, fruit and vegetable names should be marked in accordance with the content from high to low. (2) Beverages which ndo ot disclose the name of all the fruits and vegetables, should be labeled "integrated fruit/vegetable juice", "mixed fruit/vegetable juice"; similar phrase at the front of packaging.

http://www.fda.gov.tw/TC/newsContent.aspx?id=10844&chk=13c6aa38-c586-4591-a282-50b734714134&param=pn%3d1%26cid%3d3%26cchk%3d46552e96-810a-42c3-83e1-bd5e42344633#.Ux6oJ_mSzY8

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Topics: China, NHFPC, Taiwan, TFDA

EU March 2014 Food Legislation News

Posted by Elisa Servida

Mar 21, 2014 10:20:00 AM

EUROPEAN_FLAGSCC_CloudSelerant-Compliance-Cloud

New amendment in European food contaminant Regulation for citrinin

A new Commission Regulation has been published amending Regulation (EC) No 1881/2006 as regards maximum levels of the contaminant citrinin in food supplements based on rice fermented with red yeast Monascus purpureus.

Commission Reglation (EU) 212/2014

 

New maximum residue limits for triptorelin acetate and tildipirosin

Two new Commission Implementing Regulation have been published amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance triptorelin acetate and tildipirosin.

Commission Implementig Regulation (EU) 200/2014

Commission Implementig Regulation (EU) 201/2014

 

New Commission Regulation on food contact materials

A new Commission Regulation has been published amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food

Commission Regulation (EU) 202/2014

 

New Commission Regulation for Salmonella in pig carcases

A new Commission Regulation has been published amending Regulation (EC) No 2073/2005 as regards Salmonella in pig carcases.

Commisison Regulation (EU) 217/2014

 

Addition of Vitamins and Minerals to foods

The Regulation 1925/2006 is on the addition of vitamins and minerals and of certain other substances to foods. Annex I is a list of vitamins and minerals which may be added to foods and Annex II is a list of the sources of vitamins and minerals which may be added to foods.

A new Commission Regulation (EU) No 119/2014 has been published this year amending Annexes I and II.

More info here

 

The main novelties of the regulation 1169/2011 compared to Directive No 2000/13/EC and Directive No 90/496/EEC

Read more here

Read More

Topics: labeling, European Commission, contaminants, veterinary drug residues, microbiological criteria, nutrition, Food contact materials, Vitamins and minerals, European Union

New FDA Labeling Rules: Overview and Compliance Solutions

Posted by Alice Zhao

Mar 20, 2014 11:27:00 AM

us_label_facts

The Nutrition Facts label has been required on food packages for 20 years, helping consumers better understand the nutritional value of foods so they can make healthy choices for themselves and their families and encouraging innovation by giving manufacturers an incentive to improve the nutrition profiles of foods. The label has not changed significantly since 2006 when information on trans fat had to be declared on the label, prompting manufacturers to reduce partially hydrogenated oils, the main source of trans fat, in many of their products.

On the 3th of March 2014, the Food and Drug Administration (FDA) issued two Proposed Rules:

1-    Food Labeling: Revision of the Nutrition and Supplement Facts Label, which addresses new scientific information (including evidence on nutrition, obesity and chronic disease) and design changes.   

2-    Serving Sizes of Foods that can Reasonably be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments, which addresses revised serving size requirements, criteria for labeling based on package size, and other issues.

Major proposed changes can be grouped into three categories: 

 

1. Changes based on new nutrition science.

  • Mandatory declaration of added sugars, when present. The FDA announced in its press release, “The 2010 Dietary Guidelines for Americans states that intake of added sugar is too high in the U.S. population and should be reduced”. Therefore the agency proposes the declaration of added sugars to help consumers know how much sugar has been added to the product. In particular FDA proposes to require a separate declaration of “Added Sugars,” on an indented line under the current “Sugars” declaration.

  • Daily value adjustments. Revise the Daily Values for a variety of nutrients such as sodium, dietary fiber and Vitamin D. Daily Values are used to calculate the Percent Daily Value on the label, which helps consumers understand the nutrition information in the context of a total daily diet.

  • Removal of the mandatory declaration “Calories from Fat”. While continuing to require “Total Fat,” “Saturated Fat,” and “Trans Fat” on the label, “Calories from Fat” would be removed because research shows the type of fat is more important than the amount.

  • List of mandatory nutrients. Require the declaration of potassium and vitamin D, nutrients that some in the U.S. population are not getting enough of, which puts them at higher risk for chronic disease. Vitamins A and C would no longer be required on the label, though manufacturers could declare them voluntarily.

2. Updated serving size requirements and labeling for certain packages.

  • Serving Size requirements. Change from ideal serving sizes to a more realistic one based on actual consumption. Moreover require that packaged foods, including drinks, that are typically eaten in one sitting be labeled as a single serving and that calorie and nutrient information be declared for the entire package. (Ex: a 20-ounce bottle of soda, typically consumed in a single sitting, would be labeled as one serving rather than as more than one serving)

  • Format change for larger packages.Present “dual column” labels to indicate both “per serving” and “per package” calorie and nutrition information for larger packages that could be consumed in one sitting or multiple sittings.

3. Refreshed design.

  • Highlighting Calories and serving size. Emphasizing these elements is important in addressing current public health concerns such as obesity, diabetes, and cardiovascular disease.

  • Serving size. Right justifying the actual amounts of the serving size information, reversing the order of “Serving Size” and “Servings Per Container” declarations and changing “Amount Per Serving” to “Amount per ___”, with the blank filled in with the serving size in common household measures, such as “Amount per 1 cup".

  • Shifting to the left of the label % Daily Value (DV). This is important because the Percent Daily Value tells you how much of certain nutrients you are getting from a particular food in the context of a total daily diet.

  • Replacing the listing of “Total Carbohydrate” with “Total Carbs” and indenting “Added Sugars” directly beneath the listing for “Sugars.”

  • Change the footnote to more clearly explain the meaning of the Percent Daily Value.

FDA is also proposing some corresponding updates to the Supplement Facts label on dietary supplements, including changes to daily values and units of measure.

The changes proposed affect all packaged foods except certain meat, poultry and processed egg products, which are regulated by the U.S. Department of Agriculture’s Food Safety and Inspection Service.

 

Proposed Rule: Comment Period and Entry Into Force

The proposed rules, which are published in the Federal Register, are open for comment for 90 days. FDA will consider comments received during the comment period on the proposed rules and then consider revising the rules based on its review of the comments before issuing any final rules. Once it's final, the agency has proposed giving industry two years to comply.

Interested parties can comment electronically on regulations.gov or use the links below.

“Revision of the Nutrition and Supplement Facts Labels”

“Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments”

 

Need Support to Ensure Complaint Labeling?

The unique combination of Selerant expertise in both PLM needs of the manufacturing industry and Food regulatory and scientific affairs matters makes our compliance solutions efficient to deal with legislation changes like the one proposed by FDA. Selerant compliance solutions are built to facilitate and automate computer-assisted compliance, in particular for product labeling, automating the creation of compliant ingredient lists and nutrition panels. Although our customers can set their own proprietary database of regulatory data sets in our PLM (DevEX), updating it based on legislation amendments, they also have the possibility to subscribe to our regulatory services. In the latter case, the Selerant regulatory experts, who are constantly monitoring the food law of many countries, automatically update the label templates and rules in DevEX as per the latest legislation requirements and send the updated data sets to our subscribers.

In the present case, it includes in particular:

  • the nutrition panels as revised by FDA, provided as templates to be used when creating the label;

  • the updated list of declarable nutrients, their declaration names and format as well as rounding rules;

  • updated daily values.

     

Useful links:

 

Read More

Topics: DevEX, labeling, FDA, United States

The main novelties of the regulation 1169/2011 compared to Directive No 2000/13/EC and Directive No 90/496/EEC

Posted by Alice Zhao

Mar 11, 2014 2:58:16 AM

Mandatory Food Information

shutterstock_140752450_Woman_at_Supermarket_copy

Article 9 sets out the starting point for determining the labelling information that must be provided in some form for most prepacked foods.

Let’s go through the "mandatory particulars" listed in Article 9 in details. The main novelties are highlighted in italics with more details.

1. The name of food

As it is already foreseen in the current legislation, the name of the food shall include or be accompanied by particulars as to the physical condition of the food or the specific treatment it has undergone (for example, powdered, refrozen, freeze-dried, quick-frozen, concentrated, smoked) in all cases where omission of such information could mislead the purchaser. (Annex VI, Part A).

The main changes in this area are:

  • ‘Defrosted’, in the case of food frozen before sale and sold defrosted, the name of such product shall include the designation “defrosted” (Annex VI, Part A, Point 2);
  • Ingredient used for substitution, where consumers expect the product to contain a certain ingredient and this has been partially or wholly substituted. (Annex VI, Part A, Point 4);
  • Formed meat and formed fish (Annex VI, Part A, Point 7);
  • Designation of minced meat (e.g. % fat content) (Annex VI, Part B).

2. The list of ingredient

  • Caffeine contents. Drinks with high caffeine contents will have to be additionally labelled as not recommended for children or pregnant and breastfeeding women, with the actual caffeine content quoted (Annex III);
  • Added water. Meat and fish products that look like a cut, joint or slice and contain more than 5% added water will have to show this in the name of the food (Annex VI);
  • Oil and fats of vegetable origin. The provision of these ingredients on label must be followed by the indication of the specific nature of the concerned oils and fats (Annex VII, part A): may be grouped together in the list of ingredients under the designation ‘vegetable oils (fats)’ followed immediately by a list of indications of specific vegetable origin, and may be followed by the phrase ‘in varying proportions’;
  • Nano-materials.  One main novelty of this Regulation is the provision of the definition of engineered nanomaterial and the establishment of specific labeling requirements for nano-food ingredients. Ingredients present in the form of engineered nano-materials must be indicated in the list of ingredients followed by the word ‘nano’ in brackets. (Art.18).
3. The list of allergens

The new regulation requires to clearly distinguish allergens from the rest of the list of ingredients, by highlighting the allergen in the ingredients list. The name of the allergen must appear next to the name of the ingredient.  Furthermore, if several ingredients or processing aids used in the food originate from a substance causing allergies or intolerance, this must be stated on the label. (Art. 21.1-Annex II).

4. The quantity of certain ingredients or categories of ingredients, QUID. (Art. 22)

This has remained unchanged.

5. The net quantity of the food (Art. 23)

This has almost remained unchanged from Directive No 2000/13/EC apart from the point 5 of Annex IX: "where the food has been glazed, the declared net weight of the food shall be exclusive of the glaze.

6. The date of minimum durability or the use by date (Art. 24)

Annex X sets out rules for the indication of the date of minimum durability, use-by date and date of freezing. Under the new rules, the date of first freezing preceded by the words “frozen on” is also required on labels of unprocessed frozen meat and fishery products.

The “use by” date must be indicated on each individual pre-packed portion (Annex X, Point 2) and no longer on the packaging containing the single packs.

Moreover, in the list of products of Annex X which are exempt from the requirement to indicate minimum durability date or ‘use by’ date, with Regulation 1169/2011 two categories are no longer exempt:

  • soft drinks, fruit juices, fruit nectars and alcoholic beverages in individual containers of more than five litres, intended for supply to mass caterers;
  • individual portions of ice-cream.

7. Any special storage conditions and/or conditions of use (Art. 25)

This has remained unchanged.

8. The name or business name and address of the food business operator referred to in Art. 8

Regulation 1169/2011 clarifies that the food business operator responsible for compliance with the food labeling rules is the operator under whose name or business the food is marketed, or if established outside the EU, the importer into the EU market. As the Regulation applies to food business operators at all stages of the food chain, they shall not supply food which they know or presume not to be in compliance with the food labeling requirements. In addition, food business operators will be responsible for any changes they make to food information accompanying a food.

9. The country of origin or place of provenance where provided for in Art. 26

Under the current EU laws established by Directive 2000/13/EC, it is mandatory to provide country of origin for fresh beef and beef products, honey, fruit, vegetables, fish, and olive oil and whenever its absence is likely to mislead consumers as to the relevant product’s true country of origin. Regulation 1169/2011 extends the mandatory country of origin labeling to meat listed in Annex XI (swine, sheep and goat, poultry) and when the country of origin of a food is not the same as its primary ingredient.

Furthermore the European Commission will have two or three years to carry out feasibility study on providing the mandatory indication of the country of origin or place of provenance for the following foods:

  • other type of meats other than the above;
  • to milk;
  • milk used as an ingredient in dairy products;nprocessed foods;
  • single ingredient products;
  • ingredients that represent more than 50% of a food.

10. Instructions for use where it would be difficult to make appropriate use of the food in the absence of such instructions (Art. 27)

This has remained unchanged.

11. With respect to beverages containing more than 1,2 % by volume of alcohol, the actual alcoholic strength by volume (Art. 28)

Since they are subject to a specific EU Regime, alcoholic beverages (≥1,2 % Vol.) are exempted from the information requirements concerning nutrition information and the ingredients list except for allergens (Art.16.4). However for the deadline of December 2014, the commission will produce a report addressing “whether alcoholic beverages should in future be covered, in particular, by requirement to provide the information on the energy value”.

12. A nutrition declaration. (Art. 29-35)

According to Regulation 1169/2011, nutrition labeling will become mandatory. Therefore, information on the energy content as well as amounts of fat, saturates fat, carbohydrates, sugar, protein and salt (not sodium), expressed per 100 grams or per 100 milliliters, must be stated in the same field of vision on food labels. Before, this requirement was voluntary unless a nutrition-related claim is made on the label or in advertising messages.

The nutrition declaration may additionally be given on a per portion basis, especially when the food is pre-packed in individual portions or consumption units, and expressed as a percentage of daily reference intakes set out in Part B of Annex XIII.

When the four nutrients (fat, saturates, sugar and salt) are repeated together with the energy value, their amounts can be expressed per portion alone. In this case, the energy value must be expressed both per portion and per 100 g/ml.

The mandatory nutrition declaration can be supplemented voluntarily with the values of other nutrients, i.e. mono-unsaturates, polyunsaturates, polyols, starch, fiber, vitamins or minerals listed in Annex XIII.

By 13 December 2014 the European Commission should provide a report and potentially a legislative proposal on the presence of trans fats in foods and in overall diets across the EU. The report will consider the provision of information to consumers on trans fats and potential restrictions on their use.

However Regulation 1169/2011 does not provide any provision for the labeling of cholesterol.

The nutrition declaration must be presented, if space permits, in tabular format with the numbers aligned or, where space does not permit, in linear format on the packing and in the same field of vision. An exemption from the requirement to provide the mandatory nutrition declaration applies to foods in small packaging.

Application of legibility rules to the nutrition declaration. The new regulation aims at ensuring that mandatory nutrition declaration is provided in a clear and legible way. For that purpose it establishes that the minimum font size that may be used on food labels is 1,2 mm for the x-height and 0,9 mm for containers with an area less than 80 cm.²

Finally, in regard to distance Selling (one of the novelties of Regulation 1169/2011), it is required the mandatory food information (Art. 9 except point f) before the purchase is concluded and it should appear on the material supporting the distance selling or be provided through other appropriate means clearly identified by the food business operator. (Art.14).

useful links:

- EU Regulation 1169/2011

- Guidance document for competent authorities, tolerances for the control of compliance of nutrient values declared on a label with EU legislation

- Questions and Answers on the application of the Regulation (EU) N° 1169/2011

- European Commission Website

- Selerant Article: "Are you ready for food labeling legislation changes in the EU?"

 

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Topics: labeling, European Commission

Are you ready for food labeling legislation changes in the EU?

Posted by Chrystele Delobel

Feb 17, 2014 11:42:16 PM

SCC_Cloud Selerant-Compliance-Cloud


The EU Law on Food Information to Consumers Law (Regulation 1169/2011) combines the 2 Directives i) on labelling, presentation and advertising of foodstuffs (2000/13/EC) and ii) on nutrition labelling for foodstuffs (90/496/EEC) into a single legal act. It also amends current Regulations on claims (Regulation 1924/2006) and on addition of vitamins and minerals (Regulation 1925/2006).

Regulation 1169/2011 introduces new rules with respect to mandatory nutrition labeling, legibility, distance selling and engineered nanomaterials in food.

It applies to food business operators at all stages of the food chain, where their activities concern the provision of food information to consumers.

The objective of the EU Regulation is to standardize food labeling and provide greater clarity to consumers on ingredients, nutrition and allergens. It also clarifies the obligations of food business operators in the supply chain and it intends to extend the mandatory country of origin labeling to more products.

The regulation entered into force on December 13th 2011 but application dates vary.

 Key dates to recall:

January 1st 2014

For specific requirements concerning the designation of minced meat (Annex VI, the part B).

December 13th 2014

For the general labelling rules, and if provided, a nutrition declaration must use the format set out in Regulation 1169/2011, section 3:

  1. List of mandatory particulars (Art.9)

    • Name of the food(Art.17-Annex VI)

    • List of ingredients (Art.18)

    • List of allergens  (Art.21 – Annex II)

    • Quantity of certain ingredients or categories of ingredients, QUID. (Art.22)

    • Net quantity of the food (Art.23)

    • Date of minimum durability or “use by” date (Art.24)

      Except for distance selling (Art. 14)

    • Any special storage conditions and/or conditions of use (Art.25)

    • Name or business name and address of the food business operator (Art. 8.1)

    • Country of origin or place of provenance where (Art. 26)

    • Instructions for use where it would be difficult to make appropriate use of the food in the absence of such instructions (Art.27)

    • With respect to beverages containing more than 1,2 % by volume of alcohol, the actual alcoholic strength by volume (Art.28)

    • Nutrition declaration (Art.29-35)

      The mandatory nutrition declaration applies from December 13th 2016, unless already present on labels.

      The European Commission has published a Guidance document on tolerances to be applied to the nutritional declaration as well as rounding rules for the nutrient declaration. Although the Guidance document for competent authorities, tolerances for the control of compliance of nutrient values declared on a label with EU legislation has no legal status, it indicates the expected tolerances on nutrient quantities declared for general food products (Table 1), food supplements (Table 2) and in case nutritional claims are made (Table 3). This document also sets the Rounding guidelines for the nutrient declaration in nutrition labelling of foods (Table 4).

  2. The mandatory information must be printed directly on the package or on a label attached thereto and needs to meet the minimum font size (Art.13)and language (Art.15)requirements.

  3. Distance selling requirements (Art.14): Any food supplied through distance selling e.g. via the internet must meet the same information requirements as food sold in shops and the mandatory information present on the label must be made available before the purchase is concluded.

 

In addition, Annex III sets out additional mandatory labeling requirements for specific types or categories of food (Foods packaged in certain gases - Foods containing sweeteners - Foods containing licorice - Beverages with high caffeine content or foods with added caffeine - Food with added phytosterols, phytosterols esters, phytostanols or phytostanol esters - Frozen meat, frozen meat preparations and frozen unprocessed fishery products)

December 13th 2016

Nutrition declaration will be applicable to all.

To help you being compliant, the European Commission has published Questions and Answers on the application of the Regulation (EU) N° 1169/2011.

More information can be found on the EC dedicated website.

 





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EU February 2014 Food Legislation News

Posted by Chrystele Delobel

Feb 17, 2014 11:13:18 PM


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New amendments in European food labeling regulations

A new Commission Regulation has been published the December 22 2013, Regulation (EU) No. 78/2014, amending and correcting Annexes II and III to Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, as regards certain cereals causing allergies or intolerances and foods with added phytosterols, phytosterol esters, phytostanols or phytostanol esters.

In particular, point 1 of  Annex II is modified as follows: “Cereals containing gluten, namely: wheat (such as spelt and khorasan wheat), rye, barley, oats or their hybridised strains, and products thereof, except:”

In the second column of point 5.1 of Annex III, point (3) is replaced by the following: “a statement that the product is not intended for people who do not need to control their blood cholesterol level”


EFSA – Review of Pesticide MRLs

 In February, EFSA has published different reasoned opinion on the review of existing pesticide MRLS:

-        Reasoned opinion on the review of the existing maximum residue levels (MRLs) for metalaxyl according to Article 12 of Regulation (EC) No 396/2005

-        Reasoned opinion on the review of the existing MRLs for carbofuran, carbosulfan, benfuracarb and furathiocarb and the setting of an import tolerance for carbofuran in cultivated mushrooms

-        Reasoned opinion on the review of the existing maximum residue levels (MRLs) for dichlorprop-P according to Article 12 of Regulation (EC) No 396/2005

-        Reasoned opinion on the modification of the existing MRLs for chromafenozide in pome fruits and grapes

 More publications here.


FVO – Audit China Wood packaging materials

 In June 2013, the European Commission Food and Veterinary Office (FVO) conducted an audit in China as per wood packaging materials. The audit was undertaken in response to continued interceptions in the EU of wood packaging material (WPM) from China with harmful organisms (Asian longhorn beetle – Anoplophora glabripennis (Motschulsky) (ALB); longhorn beetles, other than ALB, belonging to the family Cerambicidae, such as Apriona gemarii, Aromia bungii, Batocera sp., Clorophorus sp.; non-European species of the genus Monochamus and nematodes of the genus Bursaphelenchus.

 The report concluded that the current system of official controls in China does not adequately ensure that WPM, which forms part of consignments of goods, exported to the EU is marked according to ISPM (International Standard for Phytosanitary Measures) No. 15 and that WPM with an ISPM mark has been treated according to the provisions of ISPM 15.


New amendment in European Food Additives Regulation

 A new Commission Regulation amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of sulphur dioxide - sulphites (E 220-228) in aromatised wine-based products has been pulished at the end of January.


New amendments for European Pesticides Residues Regulation

Five new  Commission Regulations amending Annexes to Regulation (EC) No 396/2005 of the European Parliament and of the Council regarding European Pesticides Residues in Food Regulations have been published.

Amendments concern maximum residue levels for acetamiprid, butralin, chlorotoluron, daminozide, isoproturon, picoxystrobin, pyrimethanil, trinexapac, bifenazate, chlorpropham, esfenvalerate, fludioxonil, thiobencarb, cyromazine, fenpropidin, formetanate, oxamyl, tebuconazole aminopyralid, chlorantraniliprole, cyflufenamid, mepiquat, metalaxyl-M, propamocarb, pyriofenone, quinoxyfen, dimethomorph, indoxacarb and pyraclostrobin in or on certain products.

Regulation (EU) No 36/2014 

Regulation (EU) No 51/2014 

Regulation (EU) No 61/2014 

Regulation (EU) No 79/2014

Regulation (EU) No 87/2014

Regulation (EU) No 59/2014

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Topics: Food Additives, European Commission

India Food legislation news February 2014

Posted by Chrystele Delobel

Feb 17, 2014 11:09:26 PM


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Food Safety and Standards (Packaging and Labeling) Regulations in India

In 2013, the Food Safety and Standards Authority of India has published several notifications on the Food Safety and Standards (packaging and Labeling) Regulation 2011:

 

-        Extended time period to comply with India packaging and labeling requirements

Extending time period for complying with requirement under the Gazette Notifications No. P 15014/1/2011-PFA/FSSAI, dated 27.06.2013 (Dated : 06-11-2013): Food Business Operators have up to July 1st 2014 to comply with the requirements of the Food Safety and Standards (Packaging and Labeling) Regulation 2011.

 

-        Food Safety and Standards (Packaging and Labeling) Amendment Regulations, 2013

Notification of Food Safety and Standards (Packaging and Labelling) second amendment Regulations, 2013 (relating to transfatty acid). (Dated : 09-07-2013)

 Notification of Food Safety and Standards (Packaging and Labeling) first amendment Regulations, 2013 (relating to license number on label). (Dated : 20-08-2013): license number shall be displayed on the principal display panel (format indicated in the notification).

Notification No. 4/15015/30/2011 dated 7th June, 2013 relating to the FSSAI license number and logo on the label of the food products. (Dated : 31-10-2013): guideline on the FSSAI logo and license number displayed on labels.


 

Food Safety and Standards (Food Products Standards and food additives) Regulations in India

In June 2013, the Food Safety and Standards Authority of Indian has published a notification relating to the use of polyols in foods: Notification of Food Safety and Standards (Food Products Standards and food additives) first amendment Regulations, 2013 (relating to Titanium dioxide in chewing gum). (Dated :20-08-2013).

 

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US Food Legislation News February 2014

Posted by Nicola Colombo

Feb 17, 2014 11:04:01 PM

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FSIS Directive 7221.1: Prior Labeling approval

In January 2014, the FSIS has published Directive 7221.1 which cancels and replaces FSIS Directive 7221.1 amend. 1., Prior Labeling Approval, dated 08/19/1996. FSIS is reissuing this directive because the final rule “Prior Label Approval System: Generic Label Approval,” effective January 6th, 2014, expands generic label approval:

-        Generic label approval criteria have been expanded and are in 9 CFR 412.

-        Any label that does not require evaluation by the Labeling and Program Delivery Staff (LPDS) as described in 9 CFR 412 is generically approved by FSIS without evaluation if the label displays all mandatory label features in compliance with applicable Federal regulations.

-        IPP are to verify establishments receive necessary label approval and compliance with labeling requirements through the General Labeling task in PHIS.

 Mandatory labeling features are: product name, safe handling statement, ingredients statement, the name and place of business of the manufacturer, packer or distributor, net weight, legend, safe handling instructions, and nutrition labeling.

 Directive 7221.1

9 CFR, PART 412

FSIS Label Submission and Approval System (LSAS)

FSIS labeling ingredients guidance

 

FSIS – New technology Tables

In February, the FSIS has published a list of test kits that have been validated for detection of relevant foodborne pathogens (i.e. Salmonella, Campylobacter, E. coli O157:H7, and Listeria spp. including L. monocytogenes).

Foodborne Pathogen Test Kits Validated by Independent Organizations

 FSIS defines "new technology" as a new, or new application of, equipment, substances, methods, processes, or procedures affecting the slaughter of livestock and poultry or processing of meat, poultry, or egg products.

FSIS New Technology Table

FDA Requests Comments about Draft Methodological Approach for identifyingHigh-Risk Foods

February 4, 2014: In order to track and trace high-risk foods under section 204(d)(2) of the FDA Food Safety Modernization Act (FSMA), FDA presented its draft methodological approach to designating such foods during a foodborne illness outbreak or other event. This approach evaluates chemical and microbial hazards combined with foods (i.e. food-hazard pairs) using criteria of section 204(d)(2)(A) of FSMA.

Comments may include: alternative approaches for identifying high-risk foods, whether or not the criteria should be weighted equally, changes in the scoring system, how foods should be categorized. The comment period opens February 4, 2014 and ends on April 7, 2014.

Comments onDocket No. FDA-2014-N-0053

For more information: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm380210.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

FDA's quality control procedures, notification, record and reporting requirements for manufacturers of infant formula products

February 10, 2014: The Food and Drug Administration (FDA) established an interim final rule setting up the requirements for current good manufacturing practices (CGMP), quality factors, quality control procedures, notification, record and reporting for infant formula products. This interim final rule is effective July 10, 2014.

Comments on Docket No. FDA-1995-N-0036 (formerly 95N-0309), by March 27, 2014

Pesticides residues in food, new tolerances from EPA

February 12, 2014: Since January, 7 2014 the Environmental Protection Agency (EPA)  has released new pesticides tolerances for the following substances:

Dimethyl Esters of Glutaric Acid, Succinic Acid, and Adipic Acid (40 CFR 180.910) https://www.federalregister.gov/articles/2014/01/06/2013-31582/dimethyl-esters-of-glutaric-acid-ie-dimethyl-glutarate-succinic-acid-ie-dimethyl-succinate-and

Tolfenpyrad (40 CFR 180.675) https://www.federalregister.gov/articles/2014/01/09/2014-00163/tolfenpyrad-pesticide-tolerances

Dinotefuran (40 CFR 180.603) https://www.federalregister.gov/articles/2014/01/22/2014-01079/dinotefuran-pesticide-tolerances-for-emergency-exemptions

Acetochlor (40 CFR 180.470) https://www.federalregister.gov/articles/2014/01/22/2014-01183/acetochlor-pesticide-tolerances

Indaziflam (40 CFR 180.653) https://www.federalregister.gov/articles/2014/01/29/2014-01363/indaziflam-pesticide-tolerances

Diflubenzuron (40 CFR 180.377) https://www.federalregister.gov/articles/2014/01/31/2014-02064/diflubenzuron-pesticide-tolerances

[alpha]lpha-Alkyl-[omega]-Hydroxypoly (Oxypropylene) and/or Poly (Oxyethylene) Polymers Where the Alkyl Chain Contains a Minimum of Six Carbons etc (40 CFR 180.910/930/940/960) https://www.federalregister.gov/articles/2014/02/03/2014-02203/alphalpha-alkyl-omega-hydroxypoly-oxypropylene-andor-poly-oxyethylene-polymers-where-the-alkyl-chain

Cyantraniliprole (40 CFR 180.672) https://www.federalregister.gov/articles/2014/02/05/2014-02210/cyantraniliprole-pesticide-tolerances

Chlorantraniliprole (40 CFR 180.628) https://www.federalregister.gov/articles/2014/02/07/2014-02568/chlorantraniliprole-pesticide-tolerances

D-mannose (40 CFR 180.920) https://www.federalregister.gov/articles/2014/02/07/2014-02694/d-mannose-exemption-from-the-requirement-of-a-tolerance

Thiram (40 CFR 180.132) https://www.federalregister.gov/articles/2014/02/12/2014-03074/thiram-pesticide-tolerances

Linuron (40 CFR 180.184) https://www.federalregister.gov/articles/2014/02/12/2014-03077/linuron-pesticide-tolerances

 

 

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