1101

Authorisation procedure and Trade Register aspects for NACE 1101

For registering with the Trade Register (ONRC) the activity of distilling, refining and blending alcoholic beverages (NACE 1101), it is mandatory to submit a file with specific documents: the certificate of registration, the articles of association, proof of registered office (loan agreement, lease or ownership deed) and a land registry extract certifying that the property is authorised for production. In accordance with Law 359/2004, a sworn declaration is submitted upon registration stating that the premises meet the legal operating conditions. Without this declaration, the Trade Register does not finalise the registration.

A distinct essential step is obtaining the sanitary authorisation for operation from the County Public Health Directorate, according to Ministry of Health Order 1030/2009. This is requested after registration with the Trade Register, prior to starting production. The procedure involves an inspection of hygiene conditions, spaces, ventilation and equipment, finalised with a report. Any modification of the premises or the technological flow requires re-authorisation.

Also, the National Authority for Consumer Protection (ANPC) may carry out unannounced checks on labelling and product quality. The operator must demonstrate traceability of raw materials and compliance with EC Regulation 110/2008 on the definition, description and labelling of spirit drinks.

Regulatory framework, specific permits and control institutions

The distillation activity is strictly regulated by Law 368/2007 on the production and marketing of alcoholic beverages, supplemented by norms of the Tax Authority (ANAF) and the Ministry of Agriculture. For the production of spirits, it is mandatory to obtain the producer authorisation from the County Agriculture Directorate, together with registration with the National Sanitary Veterinary and Food Safety Authority (ANSVSA) if raw materials of animal origin are used (e.g., whey for distillation).

An essential permit is that from the Labour Inspectorate (ITM) for occupational health and safety, given the specific risks: handling ethyl alcohol (flammable substance, classified H225), use of pressurised equipment (alembics, distillation columns) which must be periodically checked by the State Inspectorate for Boilers, Pressure Vessels and Lifting Equipment (ISCIR). Without these checks, insurance and operation are not allowed.

In addition, obtaining the environmental permit from the Environmental Protection Agency is mandatory, as distillation generates volatile emissions (volatile organic compounds - VOCs) and waste with alcohol content. Classification under pollution categories is done according to Law 151/2014 and may require an impact study. Failure to obtain this permit results in fines and suspension of activity.

Tax management, ANAF audit risk and specific accounting

From a tax perspective, the operator must register as an excise duty payer with the Tax Authority (ANAF), according to the Fiscal Code (Title VIII). Excise duties are calculated based on the final alcoholic strength (hectolitres % vol.) and are paid before release for consumption. A monthly excise return (Form 390) is submitted, and failure to meet deadlines results in penalties and confiscation of goods. Stocks of alcohol and raw materials must be managed in separate accounts, and ANAF checks any discrepancy of at least 1% through operational control.

A major audit risk relates to transfer pricing if the raw material is purchased from a foreign affiliate. ANAF compares costs against market averages. Also, expenses for advertising and promotions of alcoholic beverages are non-deductible under Article 25 of the Fiscal Code, except for strictly technical ones. It is recommended to maintain an annual transfer pricing documentation file.

Specific accounting requires separate recording of excise duties in account 378 'Price differences on goods' or 381 'Packaging', and stocks are valued at production cost or purchase price plus excise paid. The single declaration (Form 212) for authorised individuals is submitted annually. For online sales, integration with the RO e-Factura system is mandatory if invoices are issued to legal entities, with a transmission deadline of 5 working days from issuance.

To avoid audit risks, periodic consultation with a tax specialist is recommended, as well as maintaining supporting documents regarding production traceability, purchase invoices and laboratory analyses of beverages. Any error in calculating excise duties may lead to reclassification of income and administrative sanctions.