Is MHRA certification required for the export of electronic cigarettes to the UK
Date:2023-01-09 09:44:47 Classification
:【question】 Visits:
On December 17, 2020, the European Commission announced that the Northern Ireland Protocol would enter into force; After several extensions, this document will enter into force on June 30, 2021. According to this document, Northern Ireland will remain in the EU Customs Union and the Single Market after the Brexit of the UK. Goods transported from other parts of the UK to Northern Ireland must be subject to the inspection of EU rules.
MHRA Testing Requirements
Test the content of the following chemical substances in the smoke released from the electronic cigarette, the first three items of the test for products without tobacco and all seven items of the test for products with tobacco and oil
MHRA test items
1 Nicotine consistency/Nicotine stably releases Nicotine/Nicotine (test 5 groups of data and evaluate the stability of release)
2Carbonyl Compounds/carbonyl compounds Formaldehyde/formaldehyde Acetaldehyde/acetaldehyde Acrolein/acrolein crotonaldehyde/butyraldehyde/butyraldehyde/propionaldehyde methyl ethyl ketone/methyl ethyl ketone acetate/acetone
3Trace Metals/Trace Metals Chromium/Chromium Nickel/Nickel Iron/Iron Aluminum/Aluminum Tin/Tin Lead/Lead Cadmium/Cadmium atomic/Arsenic Antimony/Antimony Copper/Copper mercury
4Flavor/Acetyl Diacetyl/Diacetyl Pentane 2,3 dione/Acetyl
5Glycol/alcohol Ethylene Glycol/ethylene glycol Glycol/diethylene glycol
6Tobacco Specific Nitrosamines/N-nitrosonotonine (NNN) 4 - (N-methylnitrosamino) - 1 - (3-pyridyl) - 1-butanone (NNK) N-nitrosoanasabine (NAT) N-nitrosoanasine (NAB)
7VOC substances toluene/toluene benzene/benzene 1.3-butadiene/1.3 butadiene isoprene/isoprene
MHRA Registration Process
1. Register MHRA Protol account and obtain company number
2. Collect basic product information, production process documents, instructions for adding smoke to the atomizer, smoke test reports, product composition information, composition CLP classification and TOX information, assign different EC-IDs to different products, and submit registration information through MHRA Protol, an online portal of MHRA
3. The UK MHRA receives the registration documents, sends INVOICE to the applicant, and the applicant pays according to the INVOICE requirements, waiting for the review results and publishing
2. British Representative
The TPD Directive clearly mentions that manufacturers outside the UK must appoint natural persons or legal persons within the UK as their representatives when selling electronic cigarette products in the UK.
1. The UK representative must be a natural or legal person in the UK
2. The UK representative must be authorized by the manufacturer
3. Responsibilities of the UK Representative:
a. Check the technical documents and declaration of conformity of products to ensure compliance with relevant UK regulations and harmonized standards
b. If required by the market surveillance authority, necessary information and documents shall be provided to them in a timely manner
c. If you know that the product involves some risks, you should take the initiative to report to the market supervision authority
d. Ensure that necessary corrective actions are taken immediately in case of product problems
4. Information of the British representative: name or company name or registered trademark, contact information and mailing address must be shown on the product or package, package or attached documents
3. FCM (Food Contact Material)
The oil storage bin of the electronic cigarette is in contact with the electronic cigarette oil for a long time, and then the cigarette oil will be atomized and inhaled by consumers. Therefore, the materials in contact with the cigarette oil in the oil storage bin must meet the requirements of the food contact material standards.
The UK still follows the EU Regulation (EC) No 1935/2004