Macau
The supervision of food exported to Macau is mainly carried out by the Pharmaceutical Affairs Department of the Macau Health Bureau, the Macau Food Safety Center, the Macau Customs, the Macau Printing Bureau, the Macau Consumer Council, the Macau Municipal Administration, etc. Establish laws, regulations, and supervision for imported food. Product compliance, access procedures, and regulatory practices are introduced by category.
The main laws and regulations referenced include but are not limited to:
1. Classification criteria for oral preparations containing vitamins and or minerals Technical Instruction No. 01/2003
2. Classification Standard for Products Containing Chinese Herbal Medicines and/or Natural Medicinal Ingredients for Administration to Human Body Technical Instruction No. 02/2005
3. Decree No. 53/94/M on the List of Chinese Herbal Medicines Used in the Macao SAR, Directive No. 7/SS/2004
4. Guidelines for the use of Chinese herbal medicine Fuzi
Documents required for application
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01
Fill in the "Product Classification Application" and/or "Product Classification Application Supplemental Pages"
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02
The original of product packaging, labels and instructions .(if the product itself lacks any information, the applicant should indicate and explain)
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03
Product full ingredient information
Pharmacist's conclusion judgment (part)
According to Article 2 (b) of Decree 58/90/M, of September 19, Article 1 (2) of Decree Law 53/94/M, of November 14, Technical Instructions of Macau Health Bureau and the approval of the Deputy Director of the General Health Care System of the Health Bureau on April 9, 2020 in Report/Proposal 00278/122/DFF/DAF/2020, the results will be available in about 18 working days.There are generally four types of results: Chinese patent medicine; medicine (Western medicine); non-drug, Chinese patent medicine or traditional (natural) medicine; traditional (natural) medicine.
"Medicines (Western Medicine)", " Chinese patent medicine" or "Traditional (Natural) Medicines" can only be imported by companies that has drug import, export and wholesale licenses, and each import must be preapproved by the Health Bureau. The import of the above-mentioned products that are not classified as "drugs (western medicines)", "proprietary Chinese medicines" or "traditional (natural) medicines" is not subject to the preapproval of the Health Bureau, but their packaging, instructions, labels and advertisements must not mention Or advertise any indication for the prevention or treatment of disease.
In addition, advertisements for "medicines (western medicines)", "proprietary Chinese medicines" or "traditional (natural) medicines" are regulated by Decree No. 30/95/M, while any advertisement of products promoting health benefits is subject to Article 7/ Regulated by Law 89/M
Furthermore, we urge your business owners to note that this official letter cannot be used for any form of advertising, nor can it be used as any proof to ensure the quality, safety and effectiveness of the above-mentioned products.
We can assist including but not limited to the following:
1. Provide feasibility analysis in advance according to the production mode and product elements, and provide the best classification application solution after comprehensive research and judgment;
2. Screen and sort out all kinds of test reports and manufacturer certificates, and only take what is needed;
3. Full ingredient information checking and calculation and label preparation;
4. The response to missing materials and the application of other compliance remedies;
5. Assist in collating and completing all application materials, and assign Macao local to complete the application submission on site;
6. Material modification and real-time situation clarification;
7. Communicate directly with pharmacists throughout the process, and do definitive work in order to apply with high quality and efficiency;
8. Receive the classification application report;
9. Customs clearance assistance and guidance, according to the actual needs of your enterprise and the requirements of Macao trade laws and regulations, our Macao branch can be the trade receiver, making the trade practice unimpeded from the very beginning;
10. Any other assistance work for the purpose of application;
Take a customer example: Swisse,world-renowned functional foods brand
Tips for registration
Infant milk powder and young children's milk powder exported to Macao is a more stringent supervision of the category of goods, in addition to meet the general food on food ingredients, food additives, nutrients, pesticide residues, veterinary drug residues, heavy metal contaminants, product labeling and other standards and limits, and should focus on meeting the following regulations (including but not limited to):
Administrative Regulation No. 28/2016 Nutritional Content Requirements for Infant Formula
Administrative Regulation No. 2/2016 Limits of Pathogenic Microorganisms in Dairy Foods
Administrative Regulation No.16/2015 Limits of Pathogenic Microorganisms in Infant Formula
Tips for import license
Laws and Regulation:
Administrative Regulation No.11/2020 Maximum Residue Limits for Pesticides in Food
Administrative Regulation No.7/2019 Standard for the Use of Preservatives and Antioxidants in Food
Administrative Regulation No.23/2018 Maximum Levels for Heavy Metal Contaminants in Food
Administrative Regulation No. 12/2018 Standard for the Use of Sweeteners in Food
Administrative Regulation No.30/2017 Standard for the Use of Food Coloring in Food
Administrative Regulation No. 13/2016 Maximum Limits for Mycotoxins in Food
Administrative Regulation No.3/2016 Amending Administrative Regulation No. 6/2014 on the List of Prohibited Substances in Food
Administrative Regulation No.16/2014 Maximum Levels for Radionuclides in Food
Administrative Regulation No.6/2014 List of Prohibited Substances in Food
Administrative Regulation No.13/2013 Maximum Residue Limits of Veterinary Drugs in Food
Law No. 5/2013 Food Safety Law
Decree-Law No. 50/92/M laying down the conditions to be observed for the labelling of cooked food products supplied to consumers
Administrative Regulation No. 40/2004 Sanitary and Phytosanitary Quarantine
Chief Executive's Order No. 556/2009 Announcement of the specific names of general food additives, their functions and their sub-function classifications according to the nature of their use
Decree-Law No. 56/94/M Amending Decree-Law No. 50/92/M of August 17, regulating the procedures for labelling various types of food products supplied to consumers
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Import license / declaration procedures and quarantine appointment |
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Annex III to Chief Executive's Order No. 487/2016 – List of Goods Subject to Sanitary/Plant Quarantine |
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Name of goods |
Macao Foreign Trade Goods Classification List/Harmonized System Number (NCEM/SH) (Sixth Revised Edition) |
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live animals |
Chapter One |
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Meat and edible offal |
Chapter Two |
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Fish, crustaceans, mollusks and other aquatic invertebrates, other than ornamental fish of term 0301.11.00 and 0301.19.00 |
Chapter Three |
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Dairy products, except infant formula of term 0402.21.20; poultry eggs; natural nectar; food animal products not listed |
Chapter Four |
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Animals (except fish) intestines, bladders and stomachs, whole or in part, in fresh, chilled, frozen, salted, dipped in brine, dried or smoked state |
0504.00.00 |
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Animal products not listed |
0511.10.00，0511.99.90 |
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Bulbs, tubers, root tubers, bulbs, root necks and rhizomes, in dormancy, in growth, or in flowering; chicory and roots, except those of section 12.12 |
0601 |
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Other living plants (including their roots), cuttings and grafts; mushroom fungoid |
0602 |
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Fresh cut flowers and buds suitable for bouquets or decoration |
0603.11.00至0603.19.00 |
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Fresh foliage and other parts of plants, without flowers and buds, and grass, moss and lichens, suitable for bouquets or decoration |
ex.0604.20.00 |
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Edible vegetables and certain roots and tubers, other than frozen and preserved plants |
Chapter Seven |
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Edible fruits and shell fruits, rinds of citrus fruits or melons, other than frozen and preserved fruits, dried fruits in shell |
Chapter Eight |
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Seeds, fruits and spores for sowing |
1209 |
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fresh sugar cane |
ex.1212.93.00 |
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Pork fat (including lard) and poultry fat, except those listed in Section 02.09 or 15.03 |
1501 |
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Sausages and similar products, made from meat, minced meat or blood; prepared foods made from these products |
1601 |
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Other prepared or preserved meat, offal or blood |
1602 |
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Fish, prepared or preserved; caviar and caviar substitutes made from fish eggs |
1604 |
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Crustaceans, mollusc and other aquatic invertebrates, prepared or preserved |
1605 |
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Young children's formula milk powder; other milk powder (in compliance with the provisions of Chapter 19 Notes) |
1901.10.41；1901.90.40 |
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Ice cream and other iced foods, whether or not containing cocoa |
2105.00.00 |
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Cat and dog food for retail |
2309.10.10，2309.10.90 |
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Animal or plant fertilizers, whether mixed with each other or chemically treated; fertilizers made from mixed or chemically treated animal or plant products |
3101.00.00 |
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Mobile zoo |
9508.10.20 |
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Note: "ex." means part |
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Documents must be submitted:
1. Import license and its clear photo copy
2. Import documents and their clear photocopies.
3. Original valid health certificate issued by the authority of the exporting country / region.
Registration of import sites issued by Municipal Affairs Bureau of Macau must be shown.
Cautions:
1. Fill in the registration number of controlled foreign trade activities of the Economic and Technology Development Bureau in the column of the declaration documents.
2. When applying for an appointment for import quarantine, the import date, place and time must be determined.
3. When the goods arrive in Macau for quarantine inspection, the original valid health certificate must be presented.
4. When the goods do not meet the sanitary requirements and will not be released, the entry contractor shall bear the relevant cost.
5. The supplementary documents must be submitted before / upon arrival and the documents must be completed before the relevant procedures.
6. Before importing new products, importers should consult the health and quarantine department for relevant requirements.
7. Imports not for wholesale purposes must submit a certificate and make a statement to this effect.
8. The applicant will clear the customs by himself/herself by presenting the photocopy of the license or declaration stamped by the Municipal Affairs Bureau, and hold the photocopy of the license and declaration, and go to the quarantine location at the appointed time for inspection.
9. The applicant must go through the relevant procedures at the IAM 1 working day before the goods are imported.
10. According to Law No. 7/2003 (partially amended by Law No. 3/2016) and Chief Executive's Instruction No. 487/2016, different import licenses or import declarations can be purchased for different products, and the forms can be purchased at Macau Government Printing Bureau.
11. When the goods arrive in Macau, a valid health certificate must be submitted.
1. Whether an application for classification of oral preparations containing vitamins and or minerals must be submitted on-site?
A: In some cases must be submitted and communicated on-site.
2. What should I do if the provided goods/physical samples during the application due to customs restrictions?
A: Our Macau branch can assist to solve the problems.
3. What should i do if i could not provide instruction?
A: It is not necessary to provide, but the reasons and evidence must be sufficient and reasonable, and we will handle the problem based on successful experience.
4. What should i do if i don’t have the seal?
A: We can assist to communicate with the pharmacist on site and ensure we can find a better solution.
5. How to handle the manufacturer or brand’s sealing problem under OEM/ODM business module.
A. Based on our successful experience, we will provide guidance and seal the signature.
6. Is it necessary for a local company in Macau to be the receiver during the trade.
A: Yes, our firm in Macau can assist.
7. Whether it is still subject to the labelling Decree 50/92/M after classification?
A: According to the experience of market circulation compliance, it is not restricted. (Unless officially requested, such thing has not happened yet).
8. Does the classification application conclusion have to be collected on the spot?
A: Yes, necessary materials are also needed and we can assist.
9. When milk powder is exported to Macau, does the consignee have to be a local company?
A: Yes, the import license, the application for quarantine appointment and the consignee must be a local company, as well as the registration of the import site issued by the IAM.
