Regulatory Updates

Distribution date: 31 January 2023

The Food and Drug Administration (FDA or we) is confirming the effective date of 28 October 2022, for the final rule that appeared in the Federal Register of 27 September 2022, and that amended the color additive regulations to provide for the safe use of calcium carbonate in dietary supplement tablets and capsules.

Products Covered: HS Code(s): 2936; ICS Code(s): 67

Regulation Type: Addendum to Regular Notification

Distribution date: 30 January 2023

Regulation (EU) 2019/1793 lays down rules concerning the temporary increase of official controls upon entry into the Union on certain food and feed of non-animal origin from certain third countries (in Annex I); special import conditions for certain food and feed from certain third countries due to the contamination risk by mycotoxins, including aflatoxins, pesticide residues, pentachlorophenol and dioxins and microbiological contamination (in Annex II - increased official border controls and official certificate accompanied by the results of sampling and analysis in the third country).This Implementing Regulation amends Annexes I and II to Implementing Regulation (EU) 2019/1793 by introducing the following changes:1.    Modification of measures/new measures:-         Inclusion in Annex I of palm oil from Côte d'Ivoire due to risk of contamination by Sudan dyes; granadilla, passion fruit (Passiflora ligularis, passiflora edulis) from Colombia, basil (Ocimum basilicum) and mint (Mentha) from Israel, peppers of the genus Capsicum (other than sweet) from Kenya and Rwanda, black eyed beans (Vigna unguiculata) from Madagascar due to risk of contamination by pesticide residues; Sesamum seeds from Türkiye due to risk of contamination by Salmonella;-         Delisting from Annex I (and thus, from the Regulation) of groundnuts and products produced from groundnuts from Argentina and Brazil (aflatoxins), Galia melons (C. melo var. reticulatus) from Honduras, chinese celery (Apium graveolens) and yardlong beans (Vigna unguiculata ssp. sesquipedalis, Vigna unguiculata ssp. unguiculata) from Cambodia, locust beans (carob), mucilages and thickeners, whether or not modified, derived from locust beans seeds from Morocco, groundnuts and products produced from groundnuts from Madagascar, tomato ketchup and other tomato sauces from Mexico, watermelon (Egusi, Citrullus spp.) seeds and derived products from Sierra Leone, turnips (Brassica rapa ssp. rapa) from Syria and coriander leaves, basil, mint and parsley from Viet Nam;-         Removal from Annex I and inclusion in Annex II of groundnuts and products produced from groundnuts from Bolivia, curry leaves (Bergera/Murrava koenigii) from India, turnips (Brassica rapa ssp. rapa) from Lebanon, Sesamum seeds from Nigeria and okra from Viet Nam;-         Increase in the frequency of identity and physical checks laid down in Annex I for groundnuts and products produced from groundnuts from Brazil (pesticide residues – 30%) gotukola (Centella asiatica) and mukunuwenna (Alternanthera sessilis) from Sri Lanka (30%), rice from Pakistan (aflatoxins and Ochratoxin A – 10%), lemons (Citrus limon, Citrus limonum) and grapefruits from Türkiye (30%) and cumin seeds and dried oregano from Türkiye (20%);-         Inclusion in Annex II of vanilla extract from the United States, due to contamination risk by ethylene oxide;-         Removal from Annex II and inclusion in Annex I of Brazil nuts in shell and mixtures of Brazil nuts or dried fruits containing Brazil nuts in shell from Brazil , betel leaves (Piper betle L.) from India, food supplements containing botanicals from South Korea, locust beans (carob), mucilages and thickeners, whether or not modified, derived from locust beans seeds from Malaysia, watermelon (Egusi, Citrullus spp.) seeds and derived products from Nigeria;-         Increase in the frequency of identity and physical checks laid down in Annex II for calcium carbonate from India (30%) and dried figs and products derived from dried figs from Türkiye (30%);-         Decrease in the frequency of identity and physical checks laid down in Annex II for yardlong beans (Vigna unguiculata ssp. sesquipedalis, Vigna unguiculata ssp. unguiculata) from the Dominican Republic (30%) and Peppers of the genus Capsicum from India (aflatoxins - 10%).2.    Technical adjustments to existing measures:-         To allow for a more precise identification of commodities subject to increased official controls, the TARIC sub-division for CN code ex 1211 90 86 is corrected in the entry on gotukola (Centella asiatica) from Sri Lanka in Annex I;-         To allow for a better evaluation of the data from official controls performed by the member States, it is appropriate to divide the entry on spices from India by commodities and CN codes;-         To allow for a more precise identification of goods subject to temporary increase of official controls or to special conditions at their entry into the Union, it is appropriate to include a footnote related to food supplements containing botanicals from South Korea in Annex I and from India in Annex II;-         The limits of Sudan dyes and Rhodamine B is added in footnotes of Annex I and Annex II.In addition, this Implementing Regulation amends official certificate laid down in Annex IV to Implementing Regulation (EU) 2019/1793 to allow certify compliance with the Union requirements regarding Sudan dyes and Rhodamine B and Article 14 of that Regulation regarding the transitional period.

Products Covered: Multiple commodities

Regulation Type: Regular notification

Distribution date: 30 January 2023

The Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Act (the Act) came into force on 1 January 2023. The Act now:-      extends the Act’s regulatory powers over the composition of smoked tobacco products, such as nicotine levels, so that only products that meet requirements set out in the Act and in the Smokefree Environments and Regulated Products Regulations 2021 (the regulations) can be manufactured, imported, sold or supplied in New Zealand. This is intended to make smoked tobacco products less addictive and appealing. To implement these changes a regulatory regime must be established to oversee and monitor the import, manufacture, sale and supply of smoked tobacco products in New Zealand. The Ministry of Health has developed a consultation document setting out proposed requirements for the scheme, and these proposals are currently open for consultation. The consultation process involves targeted engagement with key groups, as well as an online consultation which can be found here Proposals for the Smoked Tobacco Regulatory Regime - New Zealand Ministry of Health - Citizen Space. The Act provides that nicotine levels in the tobacco in smoked tobacco products must not exceed 0.8mg/g. This maximum applies to each individual product and includes all sources of variability. The Act also requires that regulations are made to determine whether the levels have been exceeded, including necessary conformity assessment procedures. Additionally, nicotine must not be present in any other constituent of a smoked tobacco product. These restrictions will come into force in April 2025. We propose that testing requirements include reference to analytical chemical methods to determine nicotine content, with a focus on chromatography-based technology, such as:-      a method based on the World Health Organisation (WHO)’s SOP4 – Standard operating procedure for determination of nicotine in cigarette tobacco filler, 4 validated to account for the low nicotine levels prescribed-      or alternatively a Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA) method, such as CORESTA no. 62 – Determination of Nicotine in Tobacco and Tobacco Products by Gas Chromatographic Analysis.5 Other suitable analytical methods, (eg, methods that test the nicotine content of the filler) may be possible. New Zealand wishes to provide an opportunity for members to provide any additional comment, including in relation to low-nicotine requirements and testing methods.Comments can be submitted online or sent directly to New Zealand’s TBT Enquiry Point at wto@standards.co.nz.

Products Covered: 24.01 Unmanufactured tobacco; tobacco refuse: 2401.10 – Tobacco, not stemmed/stripped: 24.02 Cigars, cheroots, cigarillos, and cigarettes, of tobacco or of tobacco substitutes: 24.03 Other manufactured tobacco and manufactured tobacco substitutes; “homogenised” or “reconstituted” tobacco; tobacco extracts and essences: Smoked tobacco products that are combustible and intended to be smoked and inhaled. This includes cigarettes, loose tobacco, pipe tobacco, roll your own tobacco, cigarillos, small cigars, cigars, and any other smoked niche tobacco product.

Regulation Type: Addendum to Regular Notification

Distribution date: 25 January 2023 | Final date for Comment: 26 March 2023

The draft law restricts production, processing, acquisition, wholesale or retail sale, storage, transportation within the state, import or export of certain doping substances (non-approved substances and anti-estrogenic substances) for sports purposes.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

Distribution date: 24 January 2023 | Final date for Comment: 25 March 2023

New draft regulations announced by Israel's Ministry of Health called "Pharmacists' Regulations (Cosmetics), 5783-2022". The proposed regulations aim to establish requirements and instructions for cosmetic products, while setting high and professional requirements for the production, marketing, and import that will ensure the safety, quality, and efficiency of and the protection of public health.

Products Covered: Cosmetics

Regulation Type: Regular notification

Distribution date: 23 January 2023 | Final date for Comment: 24 March 2023

This DraftRwanda Standard prescribes the requirements, sampling and test methods for pyrethrum-basedinsecticide formulation to be used as spray treatment (aerosol dispensers, AE) with the aim of protectingcrops, animals or public health from insects’ pest or vectors.

Products Covered: (HS code(s): 3808); Insecticides (ICS code(s): 65.100.10)

Regulation Type: Regular notification

Distribution date: 23 January 2023 | Final date for Comment: 24 March 2023

This Committee Draft prescribes the requirements, sampling and test methods for bait formulations used as insecticides against cockroaches in public health settings.

Products Covered: Insecticides (ICS code(s): 65.100.10)

Regulation Type: Regular notification

Distribution date: 23 January 2023 | Final date for Comment: 22 February 2023

The Minimum Requirements for Biological Products will be amended as follows；To add the standard for a vaccine product to be newly approved; “Nasally Live Attenuated Influenza Vaccine”, “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio Haemophilus TYPE b Combined Vaccine”. Partially amended to “Diphtheria Toxoid”, “Adsorbed Diphtheria Toxioid”, “Adsorbed Diphtheria Toxioid for Adult Use”, “Adsorbed Diphtheria-tetanus Combined Toxoid”, “Tetanus Toxoid”, “Adsorbed Tetanus Toxoid”, “Adsorbed Purified Pertussis Vaccine”, “Adsorbed Diphtheria-purified Pertussis-tetanus Combined Vaccine”, “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine”, “Freeze-dried Haemophilus TYPE b Vaccine (Tetanus Toxoid Conjugate)”, “Inactivated Polio Vaccine (Salk Vaccine)”. To delete “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Salk Vaccine) Combined Vaccine”. The test for pH and test for abnormal toxicity (“test for freedom from abnormal toxicity”) will be deleted from monographs for “Freeze-dried Inactivated Tissue Culture Hepatitis A Vaccine”, “Freeze-dried Gas Gangrene Antitoxin, Equine”, “Freeze-dried Inactivated Tissue Culture Rabies Vaccine”, “Freeze-dried Diphtheria Antitoxin, Equine”, “Freeze-dried Habu Antivenom, Equine”, “Freeze-dried Botulism Antitoxin, Equine”, “Freeze-dried Mamushi Antivenom, Equine”. The Public Notice on National Release Testing will be amended as follows；To add the standard for a vaccine product to be newly approved; “Nasally Live Attenuated Influenza Vaccine”, “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio Haemophilus TYPE b Combined Vaccine”. Partially amended to “Diphtheria Toxoid”, “Adsorbed Diphtheria Toxioid”, “Adsorbed Diphtheria Toxioid for Adult Use”, “Adsorbed Diphtheria-tetanus Combined Toxoid”, “Zoster Vaccine Recombinant, Adjuvanted”, “Tetanus Toxoid”, “Adsorbed Tetanus Toxoid”, “Adsorbed Purified Pertussis Vaccine”, “Adsorbed Diphtheria-purified Pertussis-tetanus Combined Vaccine”, “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine”, “Freeze-dried Haemophilus TYPE b Vaccine (Tetanus Toxoid Conjugate)”, “Inactivated Polio Vaccine (Salk Vaccine)” “Freeze-dried Inactivated Tissue Culture Hepatitis A Vaccine”, “Freeze-dried Gas Gangrene Antitoxin, Equine”, “Freeze-dried Inactivated Tissue Culture Rabies Vaccine”, “Freeze-dried Diphtheria Antitoxin, Equine”, “Freeze-dried Habu Antivenom, Equine”, “Freeze-dried Botulism Antitoxin, Equine”, “Freeze-dried Mamushi Antivenom, Equine”, “Human Anti-tetanus Immunoglobulin”. Accordingly, the fee, criterion and quantity for National Release Testing of the above-mentioned vaccine will be partially amended. To delete “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Salk Vaccine) Combined Vaccine”.  

Products Covered: Pharmaceutical products (HS: 30)

Regulation Type: Regular notification

Distribution date: 23 January 2023 | Final date for Comment: 24 March 2023

This Draft Rwanda Standard primarily provides general requirements for herbal cosmetic products aimed at ensuring the safety, efficacy and quality of these products for consumers.This document does not apply to cosmetic products intended to be used for medicinal purpose. 

Products Covered: Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 23 January 2023 | Final date for Comment: 24 March 2023

This  Draft Uganda Standard specifies requirements, sampling and test methods for organic fertilizers. Organic fertilizers are naturally available mineral sources that contain moderate amount of plant essential nutrients. They are capable of mitigating problems associated with synthetic fertilizers. They reduce the necessity of repeated application of synthetic fertilizers to maintain soil fertility.Organic fertilizers comprise a variety of plant-derived materials that range from fresh or dried plant material to animal manures and litters to agricultural by-products. The nutrient content of organic fertilizers varies greatly among source materials, and readily biodegradable materials make better nutrient sources. Nitrogen and phosphorus content is lower, often substantially lower, in organic fertilizers compared to chemical fertilizers.Commonly used organic fertilizers include composted animal manure, compost, sewage sludge, food processing wastes, and municipal biosolids. They improve soil health and release nutrients to soils gradually. Examples of naturally occurring organic fertilizers include manure, slurry, worm castings, peat, seaweed and guano. Green manure crops are also grown to add nutrients to the soil. Naturally, occurring minerals such as mine rock phosphate, sulfate of potash and limestone are also considered as Organic Fertilizers. Examples of manufactured organic fertilizers include compost, blood meal, bone meal and seaweed extracts. Other examples are natural enzyme digested proteins, fishmeal, and feather meal. Organic fertilizers are considered an excellent source of nutrients, providing plants with vital vitamins, and soil acts as a medium between crops and fertilizers. Fertilizers can be divided into several types, depending on their components, shape, and various other properties.Meat and bone meal is an industrial by-product obtained by treating animal carcasses with heat, removing the fat, and finally drying and mincing them. Due to the high levels of total nitrogen (8%), phosphorus (5%), and calcium (10%) in meat and bone meal, these organic matters can be considered as useful fertilizers for soil improvement.Manure is an organic fertilizer used for soil fertilization after animal waste decomposes due to bacteria and fungi. Composting manure takes a relatively long time. This decomposed manure is later used in agriculture to increase and promote soil productivity. Well-decomposed manure contains N (0.5%), P2O5 (0.3%), and K2O (0.5%). Manure is used as a fertilizer, improves soil productivity by providing practically all the elements needed by plants, but not always in the right amounts, and proportions. Slurry and solid manure are traditionally spread directly on the soil surface as fertilizers. Organic fertilizers are an alternative to minimize the environmental pollution that may be due to excessive use of inorganic fertilizers.Liquid fertiliser contains nutrient compounds that could be applied as plant enhancer and are used in foliar application, as it does not require soil medium and environmentally friendly. An organic liquid fertilizer can be produced from bio-wastes composting as it contains more organic nutrients that are essential to promote healthy plant growth.

Products Covered: Animal or vegetable fertilisers, whether or not mixed together or chemically treated; fertilisers produced by the mixing or chemical treatment of animal or vegetable products (excl. those in pellet or similar forms, or in packages with a gross weight of <= 10 kg) (HS code(s): 3101); Fertilizers (ICS code(s): 65.080)

Regulation Type: Regular notification