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Export compliance points and process description of epidemic prevention materials (hand sanitizer, disinfectant wipes, alcohol disinfectant, etc.)

Release time:

2020-05-20 11:26

The domestic epidemic gradually subsided, the trend of overseas epidemic is still very serious, due to the problem of living habits, overseas demand for hand sanitizer, alcohol disinfectant, disinfectant wipes increased greatly, which for domestic production enterprises export customs clearance, declaration and overseas countries compliance needs, become more urgent. Below, the new Anrun consulting for you to introduce the epidemic prevention materials export abroad compliance points and processes.

Disinfection supplies mainly refer to hand sanitizer, hand sanitizer, disinfectant and other supplies. They use chemical components to kill bacteria, viruses and other microorganisms, which can effectively prevent the further infection of the virus. They are necessary products for personal home epidemic prevention and disinfection of various public places during the epidemic. According to the Centers for Disease Control and Prevention (CDC), hand cleaning is one of the most important steps to avoid getting sick and prevent the spread of infectious diseases. Hand sanitizers must contain up to 60% alcohol. Disinfectants are mainly used for disinfection and sterilization in professional medical places or places such as schools, homes, offices, travel and parks.

alcohol disinfectant

A common alcoholic disinfectant is ethanol. 95% ethanol can quickly coagulate the protein on the surface of the bacteria and form a protective film to prevent ethanol from entering the bacteria, so the bacteria cannot be completely killed. If the concentration of ethanol is less than 70%, although it can enter the bacteria, it cannot coagulate the protein in the body, and it cannot kill the bacteria completely.

Only 70%-75% of ethanol can enter the bacteria smoothly, and can effectively coagulate the proteins in the bacteria, thus killing the bacteria completely. Therefore, WHO recommend 70%-75% ethanol as a hand disinfectant. 70%-75% of ethanol is dangerous goods. Among them, the disinfectant hand sanitizer also belongs to alcohol disinfectant.

Alcohol Wipes

Alcohol wipes are individually packaged in tin foil to keep them sterile and moist; 75% alcohol cotton balls can effectively clean the touch surface, remove dust, moisture and unnecessary small particles; very convenient, easy to use and compact to carry.

chlorine-containing disinfectant

84 disinfectant belongs to chlorine disinfectant, is sodium hypochlorite (NaClO) as the main active ingredient of the disinfectant, suitable for general object surface, white clothing, hospital contaminated items disinfection. Sodium hypochlorite has a strong oxidizing, can be used as a bleaching agent, can be reduced to the oxidation of the material, so that it can play a role in disinfection. 84 disinfectant has a sensitizing effect, corrosive, can cause human burns, the release of free chlorine may cause poisoning. 84 disinfectant is also a dangerous goods.

oxide disinfectant

Peracetic acid is a highly efficient peroxide disinfectant, and the gas and solution of peracetic acid have strong bactericidal ability. The peroxyacetic acid hydrolysis products are acetic acid and hydrogen peroxide. Therefore, peroxyacetic acid is a mixed aqueous solution, which contains hydrogen peroxide, acetic acid, sulfuric acid, etc. in addition to peroxyacetic acid, which is the main component. High concentration liquid has strong corrosive, irritating, also belongs to dangerous goods.

Focus: 75% disinfectant alcohol, disinfectant wipes and 84 disinfectant are all dangerous goods, which must follow the International Air Transport Dangerous Goods Rules and the International Maritime Dangerous Goods Rules.

According to the provisions of the Emergency Management Department's 2015 catalogue of hazardous chemicals, ethanol solutions with a content of more than 24% are dangerous goods, so alcohol with a content of more than 24% is dangerous goods. For example, during the epidemic, the most commonly used export is hand sanitizer with an alcohol content of 75%, which belongs to category 3 dangerous goods.

Among them, the customs supervision condition of hand sanitizer is AB, which requires the customs clearance of inbound goods and the customs clearance of outbound goods, and the legal inspection and quarantine condition of HS is M/N, which requires the inspection of imported goods and the inspection of exported goods.

Market access conditions for countries

Each country has its own compliance requirements. Before exporting, it is necessary to understand the access conditions of the exporting country in detail to prevent the impact of goods being detained and huge fines. Dangerous goods are classified mainly based on the United Nations Recommendations on the Transport of Dangerous Goods-Model Regulations, according to different modes of transport, but also in accordance with the International Maritime Dangerous Goods Code (IMDG Code), the International Air Transport Association Dangerous Goods Transport Rules (IATA DRG) and other requirements.

United States

Chemicals exported to the United States are subject to the requirements of the US Toxic Substances Control Act (TSCA). The U.S. Occupational Safety and Health Administration (OSHA) is responsible for the classification, labeling, and chemical safety data sheets of chemical substances in the workplace, and hazardous chemicals must comply with the requirements of the Hazard Transmission Standard (HCS) issued by OSHA.

In addition, in the United States, hand sanitizer is an over-the-counter (OTC) for local disinfection. Like anti-dandruff shampoo, fluoride toothpaste, sunscreen and other products, it is regulated by the Food and Drug Administration (FDA). Exporting hand sanitizer to the United States also requires FDA certification. FDA certification will require an NDC number. Domestic manufacturers must apply for the corresponding NDC number for each package OTC before exporting to the United States.

NDC(National Drug Code National Drug Verification Number) is the identification symbol of drugs as common commodities. FDA of the United States regularly edits the NDC system index, and enters the NDC number and registration information as the program to enter the Drug Registration and Listing System (DRLS) database. It includes all prescription drugs and some screened over-the-counter drugs and islet drugs. According to Section 510 of the United States Code of Federal Regulations, the NDC of each drug listed has 10 numbers and consists of three parts, namely, manufacturer number, product number and package model. The first part is the manufacturer number provided by FDA, which refers to the manufacturer that produces or sells drugs. The second part is the product number; mark the characteristics, dosage form and configuration of the product. The third part is the packaging code. The labels of the second and third parts are provided by the manufacturer. The structure of the NDC number consists of one of the following forms, I .e., 4-4-2, 5-3-2, or 5-4-1, e.g., 62684-010-10, I .e., 5-3-2.

Products with NDC can be listed in the form of drugs in the United States. Vendors can learn about the efficacy and characteristics of the products according to this number in order to order the drugs. At the same time, FDA also manages the products according to this number. The disadvantage of NDC is that there is no reference table for drug trade names and common names. Products with NDC can be listed in the form of drugs in the United States. Vendors can learn about the efficacy and characteristics of the products according to this number in order to order the drugs. At the same time, FDA also manages the products according to this number.

European Union

All substances and mixtures are classified, labeled and packaged in accordance with the EU Regulation on the Classification, Labelling and Packaging of Substances and Mixtures (CLP Regulation) and must be CE-certified. At present, the EU CE certification is mixed up with good and evil people. Please be sure to look for the CE certificate issued by the EU Notified Body (Notified Body). The CE certificates of other institutions are invalid.

Eligible hand sanitizer, spray and disinfectant wipes manufacturers can also consider the EU CPNP notification, which is faster and cheaper. For details, please consult Xinanrun.

Japan

Dangerous goods must meet the requirements of the Japanese Chemical Review Law, the full name of the Chemical Substances Review and Production Management Law (CSCL) and the Chemical Information Transmission Standard (JIS 7253) jointly implemented by the Ministry of Health, Labor and Welfare, the Ministry of Economy, Industry and the Ministry of the Environment.

South Korea

It must meet the requirements of the South Korea Chemical Substances Registration and Evaluation Act (The Act on Registration and Evaluation of Chemical Substance) (K-REACH), also known as the Chemical Assessment Act, which came into effect on January 1, 2015.

The K-REACH adopts registration, evaluation, authorization and restriction requirements similar to those of the EU REACH regulation for new chemical substances, existing chemical substances and downstream products. For chemical suppliers South Korea outside the country, the law also requires registration to be completed through a unique representative (OR) in South Korea.

Russia

Export to Russia with reference to TPTC009/2011 (Cosmetic Safety Regulations), hand sanitizer requires compulsory customs union certification, also known as customs union technical specification certification or customs union certification, abbreviated as EAC certification or CU-TR certification.

Customs Union CU‐TR Technical Regulation Certification Certificate, Russian: технических регламентов Таможенного союза сертификатов соответствия/ деклараций о соответствии, abbreviated as TP TC. English: Technical Regulations of the Customs Union conformity Certificates / Declarations of Conformity (CU-TR certification for short), because the certification mark is EAC mark, it is also called EAC certification.

During the outbreak, the U.S. FDA and the European Union have opened green channels for medical protection products to simplify the process and shorten the registration and certification time to bring these products to market as soon as possible, but this does not mean that they are not regulated or controlled. Sellers who want to apply for the export of medical and epidemic prevention supplies must keep up with policy changes, pay attention to the news, do a good job of product compliance, and better contribute to the global fight against the epidemic.

It can be seen from the above introduction that most disinfection supplies are both dangerous chemicals and dangerous goods. In addition to the certification or registration required by relevant laws and regulations, customs declaration documents also include the following materials:

Transportation Identification Report

Shipping companies generally require customers to provide a third-party inspection agency issued a certificate of the conditions of transport of the goods, to prove that the goods are dangerous goods.

Product technical specification: when the production unit or business unit provides customs declaration, it is necessary to provide the customs with a description of the situation or product specification, mainly to explain the transportation name, chemical name, molecular formula and physical and chemical characteristics of the product. such description also needs the official seal of the production unit and business unit.

MSDS Chemical Safety Specification

MSDS is the English abbreviation for the Material Safety Data Sheet (MSDS) and is often translated into chemical safety instructions. SDS (Safety Data Sheet) is a safety data sheet. SDS is one of the corporate obligations stipulated in the GHS (Globally Harmonized system of Classifi and labeling for chemicals) regulations of all countries in the world. SDS is called MSDS in certain countries, but MSDS and SDS play exactly the same role in the supply chain.

It is a comprehensive legal document on the characteristics of chemicals provided by chemical production, trade and sales enterprises to downstream customers and the public in accordance with legal requirements. It provides 16 items of chemical physical and chemical parameters, explosion performance, health hazards, safe use and storage, leakage disposal, first aid measures and relevant laws and regulations.

MSDS can be prepared by the manufacturer in accordance with the relevant rules. However, in order to ensure the accuracy and compliance of MSDS and avoid the risk of accidents in the process of production, circulation, use and storage of chemicals, it is suggested that enterprises entrust Xinanrun Consulting to provide MSDS services.

Dangerous Goods Packaging Certificate (Dangerous Package Certificate)

The production unit or business unit is required to provide the shipping company with a dangerous bag certificate (regular barrels, cartons, etc.), a pot inspection certificate (steel cylinders), a tank certificate (TANK), a classification society inspection certificate (medium bulk container), etc. to prove that the package complies with the IMDG shipping rules.

Can LCL be exported?

Whether dangerous goods can be packed depends mainly on two aspects: whether one is allowed at the wharf and whether the shipping company agrees. For example, Shanghai dangerous goods LCL is divided according to the categories of dangerous goods. Some dangerous goods of categories 2, 3, 4.1, 6, 8 and 9 can be LCL by sea. However, it should be noted that acid and alkali cannot be put together in a cabinet, and some goods need to be isolated.

Technical standards for disinfection supplies in various countries

Country	Standard No.	Chinese name	Standard Status	Release time
European Union	EN 1499-2013	Chemical disinfectants and antiseptics. Hand sanitizer. Inspection Methods and Requirements (Phase 2/Level 2)	Current	2013
	EN 1276-2009	Chemical disinfectants and antiseptics. Quantitative Suspension Test Method and Requirements for the Evaluation of Microbiological Activity of Chemical Disinfectants and Antiseptics Used in Food, Industrial, Household and Public Areas (Phase 2)	Current	2009
	EN 13697-2001	Chemical disinfectants and antiseptics. Quantitative non-porous surface test for the evaluation of the bactericidal and/or fungicidal properties of chemical disinfectants for food, industrial, domestic and public use. Non-mechanical action test method and requirements (phase 2/step 2)	Current	2001
	EN 1650-2008	Chemical disinfectants and antiseptics. Quantitative suspension test for assessment of fungicidal and bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and public areas. Test Methods and Requirements (Phase 2/Step 1)	Current	2008
	EN 14885-2006	Chemical disinfectants and antiseptics. European standards for the use of chemical disinfectants and antiseptics	Current	2006
	EN 1500-2013	Chemical Disinfectants and Antiseptics-Test Methods and Requirements for Sanitary Wipes (Phase 2/Step 2)	Current	2013
United States	ASTM E3058-2016	Standard Test Method for Determination of Residual Bactericidal Activity of Hand Disinfectant Preparations	Current	2016
	ASTM E1153-2014	Standard Test Method for Efficiency of Traded Disinfectants on Nonliving, Rigid, Nonporous Nonfood Contact Surfaces	Current	2014
	ASTM E2755-2010	Standard Test Method for Determining the Sterilizing Effectiveness of Adult Hand Cleansing Formulations	Current	2010
	USP38 1072	United States Pharmacopeia 38th Edition Part 1072 Disinfectants and Antiseptics
Japan	JIS/L1902-2008	Test method for antibacterial property of fiber products, antibacterial effect	Current	2008
	JIS/Z 7253-2012	General knowledge of chemical hazards based on the Global Harmonization System for Chemicals (GHS). Safety Data Sheets (SDS) and Labels	Current	2012
	JIS/Z 2801-2010	Antibacterial products. test for antibacterial activity and efficacy	Current	2010