The new regulation underlines the following information:

– the word “nature” can only be used when the food product is not mixed, and the process does not alter the characteristics;

– the words “pure” or “100%” can only be used for non-mixed food;

– the word “made with…” followed by the name of substance can only be used when the substance is more than 50% of the product and the substance is one of the raw material. 

Australia amended the regulations on food for special medical purposes. The main changes are as follows:

– Food used for dietary management of obesity and infant formula product are now no longer classified as food for special medical purposes;

– Inner packaging requirements are amended;

– Some mandatory labeling requirements, such as allergen declarations and labeling requirements, are revised.

The draft is open for public comment until May 10, 2021.

The new regulation requires companies to:

– Clearly specify the specific ingredient or part of the genetically modified food that needs to go through the safety review;

– Set the range of toxicity in the data submission;

– Reset the format for the application form.

New regulation about Health Supplement in Indonesia: BPOM published a new Guideline about Health Supplement and Traditional Medicine to monitor side effects.

In this new regulation, aiming to ensure product safety, the government pointed out that the owners of product registration numbers for products in health supplements and traditional medicine will respond to any complaints/reports due to side effects.

Product registration owners also have to report to the BPOM monitoring system any unwanted side effects. The scope of the dedicated report includes quality factors, safety effects linked to product use, and changes in the risk-benefit profile.

Food allergen labelling is mandatory in Australia. However, there is a need to provide the information in easy-to-find and understand formats for the consumer. The new requirements include the declaration in specific format and locations on food labels and the use of simple, plain English terms.

The allergens need to be declared in specific terms (Mandatory Declarations), in ingredient lists (bold font), and in a summary statement. There are exemptions for some foodstuff to be declared as allergens; for example soybean derivatives that are tocopherols or phytosterol are exempt.

Following up to 2 impactful Chinese cosmetics regulation drafts last Nov: the China National Medical Products Administration (NMPA) announced the “Regulations on the Management of Registration and Filing Materials for New Cosmetics Ingredients” and “Administration of Cosmetics Registration and Filing” will be effective from May 1, 2021.

Both regulations reduce manufacturers’ regulatory reporting burden, such as providing templates for some common documents and simplifying approval process.

Among them, the major change is the management of new cosmetic raw materials. From May 2021, only new high-risk cosmetic raw materials with anti-corrosion, sun protection, coloring, hair dyeing, freckle removal and whitening function claims need to be registered. Other claims only need to complete the filing process.

New limits for mycotoxins are set up and maximum levels are updated to protect the health of the very vulnerable child population.

Mycotoxins are substances produced by certain filamentous fungi as a product of their secondary metabolism. They can contaminate food, causing disorders and symptoms due to mycotoxicosis.

1) Key Summary:

All products, except the ones made from haram substance, need to be halal certified when entering Indonesia;

Halal certified products can place a new halal logo on their packaging; Haram products will have to inform that they are not halal;

This regulation will be applied gradually (depending on the type of products, from 2019 – 2034)

2) Context:

Goods: food, cosmetics, drug, health supplement, traditional medicine, quasi-drug, GMO product, medical device, and household health products.

Service: slaughtering, processing, storage, packaging, distribution, selling, and serving.

BPJPH can have mutual recognition with overseas halal bodies.

China issued technical guidelines for clinical trials of immune cell therapy products. These guidelines will affect common immune cell therapy products including CAR-T, TCR-T, TIL, CIK, etc.

As a new type of treatment, cell therapy has breakthrough significance in the treatment of cancer and other diseases. Stem cells, immune cells, and other somatic cell therapy technologies have been proven to achieve curative effects that chemotherapeutics and targeted drugs cannot achieve.

Drugs can be advertised online, including social media. The requirement is to provide only approved content.

Only OTC and OTC-limited can be advertised to the general public, whereas prescription drugs can only be advertised to health practitioners. The language must be Bahasa Indonesia unless the term has no translation.

In order to expand the formulation of health food filing products, the State Administration for Market Regulation (SAMR) released technical requirements for the filing of gummies and powders.

In addition, the registered dosage forms of health food include 7 dosage forms: tablets, hard capsules, soft capsules, oral liquids, granules, gummies, and powders.

Philippines FDA tends to expedite the approval process of some sanitizing products, such as sanitizing liquid/spray, sanitizer, etc.

In response to the COVID-19 pandemic, Philippines Food and Drug Administration (FDA) has issued revised interim guidelines for all ethanol and isopropanol products intended to be used as sanitizing, antibacterial, and antiseptic agents.

Accordingly, the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) is hereby tasked to facilitate and streamline the process of approval for these health products, a responsibility previously assigned to the Center for Drug Regulation and Research (CDRR).

Draft of Ireland Front Of Pack Labelling is open for public comments. Food Safety Authority of Ireland (FSAI) is seeking public opinion about the new Draft of Food Labelling. The deadline for comments is 25 March.

FSAI provides a questionnaire on Front of Pack Labelling, Nutrient Profiles, Origin Labelling, and Date of Marking. The purpose among others is to align with the EU policy and the harmonized mandatory front-of-pack nutrition labeling.

CFSA published a regulation draft about 9 food enzyme preparations (4-α-glucanotransferase, Alpha-amylase, Polygalacturonase, Pectin esterase, Phosphoinositide Phospholipase C, Phospholipase C, Xylanase, Glucoamylase, and Lipase) and Sucralose to expand their uses. Comments are expected till 8 March.

South Korea to enforce the Food traceability system on special-purpose food: From December 2021, South Korea @Ministry of Food and Drug Safety (MFDS) will enforce the Food traceability system for companies that earn more than 100 million and produce and import special-purpose food.

The food traceability system is to track information from all stages of food production, from processing to sales. Once a food safety incident occurs, measures such as cause analysis, tracking, and recalls will be taken accordingly.

EU adds plant-derived CBD to the CosIng database as a legal cosmetics ingredient, following the ruling of the European Court in Nov 2020 that established CBD extracted from the entire hemp plant should not be classified as a drug.

DG GROW, the market regulator for trade in the European Union, has added plant-derived CBD to the approved Cosmetic ingredient database.

Regulators list plant-derived CBD as a skin protectant and conditioner and note its function as an anti-oxidant.

China National Center for Food Safety Risk Assessment published draft regulation about 8 kinds of food contact materials, open to public comments till 27 Feb.

It includes:

-New varieties of additives for food contact materials and products, Silicic acid, sodium salt, reaction product with chlorotrimethylsilane and isopropyl alcohol

-3 kinds of additives for food contact materials and products to expand the scope of use

-4 new varieties of resins for food contact materials and products

EU will make ZPT (Zinc Pyrithione) prohibited in cosmetic products. The European Commission submitted Notifications to the @World Trade Organization related to their plans to add ZPT to the list of prohibited substance, open for comments till 23 March 2021.

Zinc Pyrithione is often used as an anti-dandruff ingredient in rinse-off hair products. When the new regulation takes effect, relevant manufacturers may need to change product formulas.

US Final Rule for the Domestic Production of Hemp will be effective on March 22, 2021.

Key provisions include:

– Producers must dispose of plants that exceed the acceptable hemp THC limit (not more than 0.3%).

– The final rule raises the negligent threshold from 0.5% to 1%.

– Allow non-DEA registered labs to test hemp until January 1, 2022.

– The timing of sample collection has been extended from a 15-day window to 30 days before harvest.

China allows Coenzyme Q10, Melatonin, Spirulina, Fish oil, and Broken Ganoderma spore Powder to be registered as health food ingredients from June 1, 2021.

The new regulation affects products being marketed in China using any of these 5 ingredients. It also provides available excipients, specific dosage forms, product technical requirements, etc.

Mexico published a Presidential decree that calls for a phase-out of both glyphosate and genetically modified corn uses. This decree states that the use of the herbicide glyphosate will be phased out over the next four years and also calls for the revocation of existing and future permits for genetically modified corn crops.

The decree directs that the use of genetically modified corn will completely stop by January 31, 2024. The Mexican government has yet to provide expected timelines or implementation details for the decree.

According to a notification from the Ministry of Public Health, hemp seed oil and extract can now be legally used in Cosmetic products. The THC level must be less than 0.2% of the total weight. This regulation only applies to Thai national individuals or companies for now. To protect and expand local varieties, hemp products cannot be imported until 20 Feb 2024.

The National Institute for Food and Drug Control amended the list of prohibited ingredients in Cosmetic products and opened it for public comments till 18 Feb 2021.

Many of the listed ingredients have already been banned by the European Union. The purpose is to ensure the safety of cosmetics ingredients for human health and comply with global cosmetic trends.

This guideline provides applicants with the mandatory information to include in their application.

The renewal assessment is now simpler. It focuses on the safety of the product unless the applicant proposes changes to the additive (e.g., its manufacturing process or composition) or the conditions of the authorization (e.g., different target species, conditions of use, etc.).

The Guideline is expected to be implemented by 27 March 2021. 

FSSAI has introduced a notification for lowering the cap on TFA in oils and fats from 5% to 3% in January 2021, and then to 2% as per of January 2022.

If manufacturers of vanaspati, margarine, shortening, and fat spreads consisting of TFA are not able to further reduce their TFA composition to 2% by 2022, they could face a ban on their products.

Singapore Food Agency (SFA) has added entry for sodium salts of 3′-sialyllactose (3′-SL) and 6′-sialyllactose (6′-SL).

These two food additives are usually used in infant formula, infant food, food for special medical purposes and food supplements. The @European Food Safety Authority (EFSA) conducted a safety assessment on them in May 2020 and gave positive feedback.

China’s first departmental regulation specifically for cosmetics registration and filing management is actually much looser than the draft for comments. One of the changes worth noting is that imported cosmetics do not require additional research and testing, so the product’s market cycle and cost will not increase. 

According to Mordor Intellience, The global polydextrose market is projected to record a CAGR of 5.4% from 2020-2025. As an important raw material for manufacturing low-calorie, low-fat, low-cholesterol, and low-sodium health foods, it can be used as a thickener, filler, and formula in food additives.

New food import requirement in Egypt: the Egyptian National Food Safety Authority announced that all food products imported into Egypt required pre-importation license issued by the NFSA, starting from 16/1/2021.

Besides the production registration fee, it also costs an annual licensing fee of 20K EGP.

Ethyl Lauroyl Arginine HCl was originally listed in the “List of Used Cosmetic Ingredients”. Now that it is officially classified as a preservative, the registration requirements are higher and more difficult. But on the other hand, it also reflects China’s more open attitude towards new raw materials.

Food Business Operators shall comply with the provisions from 1 July 2021 by adding micronutrients to reformulate the product. The new regulation also provides permissible levels of vitamins and minerals like iron, folic acid, zinc, vitamin B12, and vitamin A.

Revocation of the Standard of Identity for French dressing could provide manufacturers with greater flexibility in the product’s manufacture, and regulatory constraints could be comparable with nonstandardized foods available in the marketplace.

To enhance food control system the present decision aims at determining the additives authorised to be used in food which is handled in Egypt and will be effective on 23 March 2021 after a six-month transitional period.

Ethyl Lauroyl Arginine HCl was originally listed in the “List of Used Cosmetic Ingredients”. Now that it is officially classified as a preservative, the registration requirements are higher and more difficult. But on the other hand, it also reflects China’s more open attitude towards new raw materials.

It includes nutrient, nutrient ingredient purity, and food additive requirements. It also states that food labels must show their products’ mandatory statements and warnings.

The new regulation comes into force immediately, and Food Business Operators (FBO) shall comply by 1 July 2021. 

These 3 medical device categories are spinal plating systems, orthopedic non-spinal metallic bone screws and washers, and magnetic resonance receive-only coils.

The Royal Thai Government Gazette released a notice announcing that the leaves, fibers, branches and roots of industrial hemp and drug cannabis were removed from the ‘list of the fifth category of narcotics.’ This means that industrial hemp will become a new economic crop that can be used for industries such as textile, medicine, and cosmetic manufacturing. But planting must be approved by the relevant government departments and recreational use is still banned.

The draft amendments, open to comments until Feb 8, 2021, focus on individually certified raw materials (such as fructose, starch, and glucose), ingredients added in health functional foods (such as calcium stearate, calcium ascorbate, and magnesium), and updating the standard for converting amino acid scores of proteins.

Manufacturers can input their opinion on whether this plan is needed; the way to enhance the quality, utility, and clarity of information; and ways to minimize the process.

Products using any of these 5 ingredients should be able to more easily adapt to the Chinese market.

This cultured or cell-based meat, developed in laboratories using animal cells, will be used in nuggets manufactured by a U.S. food technology startup.

It will provide more opportunities for manufacturers of medicinal and therapeutic products.

#India #GMfree: FSSAI announced that the start date of the Non-GM Certification requirement during the Food Cord Importation will be postponed from Jan 1, 2021, to March 1, 2021.

Manufacturers will then be able to use more raw materials. They will also be allowed to leverage newly-authorized feature claims for the promotion of the products.

This draft includes the lists of raw herbal ingredients, and permitted nutraceutical and probiotic ingredients.

Manufacturers can comment it by Jan 24, 2021.

The 3 categories are:
a) Novel food and food ingredients in general
b) Novel foods that are chemically identical to naturally-occurring substances but produced by unconventional processes
c) Cultured meat

Under the new updates, claims such as anti-tumor, auxiliary anti-tumor, anti-mutation, anti-aging, lactation promotion, and improve skin oil secretion are not allowed anymore.

#EU approved the use of Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate as a UV filter in cosmetic products and authorized a maximum concentration of 3 %, except in applications that may lead to exposure of the end user’s lungs by inhalation.