Technical Evaluation Mechanism for Special Food Registration in China

Notes:

  • Designated testing agency: testing institutions which are appointed by the government to conduct relevant testing
  • The 3rd party testing agency: testing institutions with legal qualification but without governmental appointment.

To complete the special food registration in China, enterprises need to entrust testing agencies to conduct relevant testing for their products, such as stability test, hygiene test and toxicology experiment. Take health food for example, by July, 2015, former CFDA had designated 58 labs for health food registration technical evaluation , however in Oct 2017, China CFDA unveiled the “Specification for Special Food Evaluation Technical Institution” , which begins a new supervision mechanism for testing agencies.

 

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China Food Contact Materials Compliance Service

1. What are food contact materials and articles?

Definition:
All materials and articles which have contacted or are expected to comein contact with food or food additives, and may transfer to food when used under the intended conditions.

Including:
(1) food packaging materials, containers, utensils and machines that directly contact food during food production, processing, packaging, transportation, storage and selling; (2) printing ink, adhesive, grease that may directly or indirectly contact food;

Not Including:(1) detergents; (2) disinfectors; (3) public water delivery

Food contact materials and articles VS Food relative products

2. Relevant Standards for China food contact materials and articles

Basic standards: GB9685-2016 Standard for Uses of Additives for Food Contact Materials and Articles
GB 4806.1-2016 General Safety Requirements for Food Contact Materials and Articles
Product standards: Enamelled Articles, Ceramic Articles, Glass Articles, Plastic Resins, Plastic Materials and Articles, Paper
and Cardboard, Metal Materials and Articles, Paint and Coating, Rubber Materials and Articles
Testing standards:
GB 31604.1-2015 General Principle for Migration Test of food contact materials and articles
GB 5009.156-2016 General Principle to the Pretreatment for Migration Test of food contact materials and articles
Other test standards matching detection indexes
Manufacturing standards: GB 31603-2015 Good Manufacturing Practice for Food Contact Materials and Articles

 

3. Food contact materials and articles regulatory compliance
(1) What kinds of substance need a Declaration of Compliance?
Substances listed in the national standard positive list
Substances permitted by NHC as an announcement
(2) What kinds of substance need to conduct a New Substance Application?
Food packaging materials, containers and their additives not listed in the national standard positive list or not permitted by NHC as an announcement.
Food packaging materials, containers and additives intended to expand the scope of applications or the dosage.
New food contact materials and additives used in tools and equipment during food production or marketing.

4. Application workflow for new food contact materials and articles

Our service

  • Food contact materials regulation consulting/customized consulting report
  • New food contact substances application
  • Regulatory compliance analysis/new substance judgement
  • Declaration of Compliance (DoC) editing/auditing
  • Lab selection and supervision of testing
  • Regulatory compliance training
  • Regulations translation
  • Consult with competent authority
  • Supplier management

US Food Contact Substances Regulatory Compliance Service

1. What are food contact substances?

A Food contact substance (FCS) is any substance that can be reasonably be expected to become a component of or directly or indirectly affect the characteristics of any food. This is includes any substance intended for use in producing, manufacturing, packaging, processing, storing, transporting, or holding of food, including any source of radiation within the production process. The following substances are not considered food contact substances:
Substances that are generally recognized as safe (GRAS);
A substance sanctioned prior to 1958.
2. Regulatory compliance workflow

3. US FCS regulatory compliance

Declaration of Compliance (DoC) is a document that should be provided to downstream enterprises to ensure product safety and
regulatory compliance. Eective transmission of supply-chain information between supplier and customer helps assure a compliant status of the nished product for food contact.
Food Contatct Notifications (FCN)
In order to ensure food safet, the 1958 Regulation stipulates that all food additives, both direct and indirect, need to be approved by the US
FDA before use. For indirect food additives, such as FCSs, the US FDA has established an FCN procedure that states substances that are neither approved nor forbidden for use by the US FDA for use are required to submit an FCN.
Specicity of FCN: FCN is only valid for substances producers and suppliers who submit the application. Other manufacturers / suppliers need to apply to the US FDA even though it is for the same substance.

4. FCN application workflow

5. Our advantages
Strong educational background: Experienced team procient in food chemistry, food nutrition and health, food functional component, biology, toxicology, environmental elds, etc.
Language ability: Proficient in English, Japanese, German and Chinese, serving overseas clients with higher rate of efficiency.
Rich experience in regulatory compliance: Accumulating years of experience in food contact material regulatory compliance for
China, US, EU, etc. Can provide compliance services for multiple countries at the same time.
Abundant resources: Cooperate with numerous accredited laboratories in China and abroad allowing us to tailor a compliance testing strategy for each individual client.
Close relationship with authorities: Longstanding relationships with competent authorities such as US FDA and other industry professionals. These established communication channels with authorities signicantly improves service range and quality.

Our service
Food contact material regulation consulting/customized consulting report
Regulatory compliance analysis/new substance assessment
Declaration of Compliance (DoC) editing/auditing
Food contact notifcation
Lab selection and testing supervision
Regulatory compliance training
Regulation translation
Consult with competent authority
Supplier management


Contact information
REACH24H Consulting Group China REACH24H Consulting Group
14th Floor, Building 3, Haichuang Technology Center,
1288 West Wen Yi Road, Hangzhou, China (311121)
Tel: +86 571 8700 7555
Fax: +86 571 8700 7566
Email:
www.REACH24H.com
Paramount Court, Corrig Road
Sandyford, Dublin 18, Ireland
Tel: +353 1 8899 951
Fax: +353 1 6865 683
Email:
www.REACH24H.com
REACH24H USA INC.
11951 Freedom Drive, Suite 1300
Reston, Virginia 20190 USA
Tel: +1 703 596 8055
Fax: +1 703 776 9462
Email:
www.REACH24H.com

EU Food Contact Materials

1. What is FCM?
FCM is the materials and articles, including active and intelligent food contact materials and articles, which in their nished state:
(1) are intended to be brought into contact with food; or
(2) are already in contact with food and were intended for that purpose; or
(3) can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditionsof use.
Except :
(1) materials and articles which are supplied as antiques;
(2) covering or coating materials, such as the materials covering cheese rinds, prepared meat products or fruits, which form part of the food and may be consumed together with this food;
(3) xed public or private water supply equipment.
2. EU FCM Regulatory System

3. Compliance workflow

4. Compliance requirements for FCM in EU
FCM shall be manufactured in compliance with good manufacturing practice(GMP);
Constituents of FCM that may endanger human health, or lead to an unacceptable change in food and ingredient, or bring about deterioration in organoleptic characteristics can’t transfer to food under normal or foreseeable conditions of use.
Label, advertisement and specication shall not mislead consumer;
Substance not yet included in the positive list (eg: positive list of EU10/2011) shall submit an application to European food safety administration for assessment.

5. Our advantages
Abundant technical strength: Have a powerful team that consists of senior technical stas procient in food chemistry, food nutrition and health, food functional component, biology, toxicology, environment elds, etc.
International service: Our stas good at English, Japanese, German and Chinese, which can serve you more ecient.
Rich experience on regulatory compliance: Have rich experience on food contact material regulatory compliance in China, US, EU and other countries, thus we can provide multiple countries compliance service at the same time.
Abundant resources: Cooperate with many excellent laboratories at home and abroad, which can tailor for enterprise with professional and ecient test program and provide our best service to every customer.
Good relationship with authority: Have good relationships with competent authorities in EU and with professional experts, which leading to eective communication with authorities and signicantly improving our service quality and eciency.

Our service
Food contact material regulation consulting/customized consulting report
Regulatory compliance analysis/new substance judgement
Declaration of Compliance (DoC) editing/auditing
New substance application in EU
Lab selection and testing supervision
Regulatory compliance training
Regulation translation
Consult with competent authority

Contact information
REACH24H Consulting Group China REACH24H Consulting Group
14th Floor, Building 3, Haichuang Technology Center,
1288 West Wen Yi Road, Hangzhou, China (311121)
Tel: +86 571 8700 7555
Fax: +86 571 8700 7566
Email:
www.REACH24H.com
Paramount Court, Corrig Road
Sandyford, Dublin 18, Ireland
Tel: +353 1 8899 951
Fax: +353 1 6865 683
Email:
www.REACH24H.com
REACH24H USA INC.
11951 Freedom Drive, Suite 1300
Reston, Virginia 20190 USA
Tel: +1 703 596 8055
Fax: +1 703 776 9462
Email:
www.REACH24H.com

Food for Special Medical Purpose

Food for Special Medical Purpose refers to a category of foods specially processed or formulated to meet the specific nutritional needs of consumers with a limited or impaired capacity to intake, digest, absorb or metabolize conventional foods. Also, for consumers with a particular disease and/or condition, including, which includes FSMPs for infants (0-12 months) and FSMPs for peopleabove 1 year old.

Requirements

According to China’s Food Safety Law, FSMP must be registered with SAMR by providing product formula, production techniques, labels, instructions as well
as the materials that prove product safety, nutrition suciency and clinical eect of special medical purpose.
From Jan. 1, 20 1, all FSMPs manufactured within China or imported to China must be registered with SAMR prior to sale in Chinese market.
Administrative department

State Administration for Market Regulation (SAMR)

Relevant regulations
• Administrative Measures for Registration of Foods for Special Medical Purpose
• Label and Instruction of Foods for Special Medical Purpose (Trial)
• Stability Study Requirements for Foods for Special Medical Purpose (Trial)
• Requirements for Application Materials for Registration of Foods for Special Medical Purpose (Trial)
• Checkpoints and Judgment Principles for Manufacturer Field Inspection for the Registration of Foods for

REACH24H Service

Regulatory Consultation 

Communication via internet, telephone and face-to-face
Main content:
1) Management regulations of FSMP
2) Registration procedure of FSMP
3) Registration strategies of FSMP
4) Customized consultation and training

Compliance Review

Check if the FSMP complies with Chinese regulations
Main content:
1)Product formula review
2)Label review
3)Ingredients and additives review
4)Consultation on product R&D

Preview of Product Registration

Evaluate0R

Food Importation Compliance Procedure

进口食品服务

 

According to China’s Food Safety Law, imported foods shall comply with the national food safety standards of China. As required by law, food entering and exiting the country must pass inspection by quarantine agencies (local customs) and obtain safety inspection certificate.

elevant regulations

• The Law of the People’s Republic of China on Import and Export Commodity Inspection
• Implementation of the Law of the People’s Republic of China on Import and Export Commodity Inspection
• Measures for the Safety Administration of Imported and Exported Food
• The Law of the People’s Republic of China on the entry and exit animal and plant quarantine
• Implementation of the Law of the People’s Republic of China on the entry and exit animal and plant quarantine
• Provisions on the Administration of Registration of Overseas Manufacturers of Imported Foods

Administrative department
Import inspection – GACC and Local customs
Circulation and catering- SAMR and local food safety supervision departments

REACH24H Service
Regulatory Consultation
Communication via email, telephone call or face-to-face
Main content:
1) Preliminary analysis on feasibility of importation
2) Requirements of the food import regulations and procedure of regulatory compliance
3) Introduction of Customs clearance and inspection procedure
4) Other food related regulatory consultation

Ingredients Compliance Review
Check whether product (ingredients and additives) comply with Chinese regulations
Main content:
1) Confirm with client whether the product can be imported and if so, identify relevant GB standard
2) Review ingredients to identify their compliance status
3) Give suggestions on formula compliancy revision

Chinese Label Review and Design
Check if the Chinese label complies with Chinese regulations
Main content:
1) Review and revise formula
2) Review and revise Chinese label
3) Design compliant Chinese label

Customs Clearance Assistance
Prepare all required materials and qualification documents
Main content:
1) GB compliance test monitoring
2) HS code identification

Tailored Service for Supermarket

Customized Regulatory Compliance Report and Emergency Alert
Expert Analysis for Specific Standards
One-to-one customized consultation IT aided platform

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New Food Raw Material

新食品原料

Free Regulatory Consultation
Compliance review of the New food Raw material
Substantial equivalence
New food raw materials registration

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New Food Additives

食品添加剂

New Food Additives Registration

 

New food additives include:
1.The varieties of food additives that have not been listed in Food Safety National Standard (GB 2760)
2.The varieties of food additives that have not been listed in the inventory announced by NHC
3.The varieties of food additives with extended application scope or amount of usage
Requirements
According to China’s Food Safety Law, to produce or import new food additives, the manufacturer/importer should submit safety assessment materials of the intended product to the NHFPC for review. For applications that comply with food safety requirements, a license shall be approved and publicly announced. Otherwise, reasons for disapproval will be given in written notice.
Administrative department
National Health Commission of China (NHC)
Relevant regulations
• Measures for the Administration of New Varieties of Food Additives
• Provisions on the Declaration and Acceptance of Food Additives
• Food Safety National Standards for Uses of Food Additive
• Food Safety National Standards for Uses of Nutritional Fortification Substances in Foods

REACH24H Service
Regulatory Consultation 

Communication via internet, telephone and face-to-face

Main content:
1) Registration procedure of new food additives
2) Toxicological requirements of registration
3) Registration strategies for new food additives
4) Customized consultation and training

Identication of NewFood Additives

Decide whether it is a new food additive
Main content:
1) Search China Database of food additives in EU/US/JP/AUS/CA
2) Communication with experts and authorities

Extension of Scope/Volume of Use

Extend the scope or volume of use for existing food additives
Main content:
1) Preliminary evaluation: feasibility, timeline and cost
2) Dossier preparation and submission
3) Communication with experts andcompetent authorities

New Food Additives Registration

Get administrative approval for new food additives
Main content:
1) Preliminary evaluation: feasibility, timeline and cost
2) Dossier preparation and submission
3) Test monitoring for registration
4) Communication with

 

Infant Formula Compliance Service

食品接触材料服务

Requirements for infant formula
From May 1, 2014, overseas manufactures of infant formula must submit their registration applications to China GACC through their national/local competent authorities as well as pass on-site facility audit prior to China market entry. In addition, from January 1, 2018, infant formula manufactured in or exported to China must pass recipe registration and obtain the registration certicate as well as mark product registration number and instruction on the label upon importaition.

Competent Authorities
State Administration for Market Regulation (SAMR)
General Administration of Customs of China (GACC)

Relevant Regulations
Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes (AQSIQ Order 26)
Provisions on the Administration of the Registration of Overseas Manufacturers of Imported Foods (AQSIQ Order 145)
Items and Requirements of Application Materials for Registration of Infants and Young Children Milk Powder Formula Recipes (Trial)
GB 10765-2010 National Food Safety Standard Infant Formula
GB 10767-2010 National Food Safety Standard Older Infants and Young Children Formula

Our service
Overseas Manufacturer Registration
1) Pre-audit for ensuing onsite facility inspection for overseas infant formula manufacturer
2) Preview of registration materials to ensure complete and accurate
Infant Formula Registration
1) Communication on the requirements of registration materials; Preparation of registration proposal
2) Registration material translation
3) Registration dossier compilation and submission
4) Registration progress follow-up and updates
5) Preparation of supplementary materials
Infant Formula Registration Dossier Review
1) Dossier review by REACH24H technical experts
2) Review support form authoritative experts On-site Review of
Infant Formula Registration
1) On-site review of registration dossier by REACH24H experts
2) On-site review of registration dossier by authoritative experts to ensure passes CFDA audit

Why REACH24H:
Rich industry experience: we have been following and researching food regulations for over a decade and have rich experience in compliance solutions.
Profound resources and channels: we have connections with authoritative experts in the industry. Together with them we provide compliance preview services for formula registration to ensure a high approval rate.
Close connection with China food safety authorities: frequent communication with ocials from competent authorities gives us a reliable channel for information and suggestions while conducting formula registrations.
International service competency: we provide services in multiple languages including Chinese, English, Japanese, and German to our international clients
Tailored compliance service: We have served numerous Fortune 500 companies providing them with a customized high-quality service.

contact us


  • Tel: 0571-87007036
  • Fax: 0571-87007566
  • Add: 14th Floor, Building No. 3, Haichuang Technology Center, 1288 West Wen Yi Road, Hangzhou, China 311121
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