Cosmetics legislation and marketing in Romania

Română

Law no.178/2000 amended by 379/2004 -

Romanian transposition of Council Directive 76/768/EEC concerning cosmetic products

Article 1- definitions: cosmetic product, coloring agent, preservatives, UV filters, the batch number, the date of minimum durability, notification, the principle of good manufacturing practice, labeling, primary packaging, secondary packaging, finished cosmetic product, prototype, the period after disclosure

Article 3- the list with product considered as cosmetic annex 1

Article 4- The Ministry of Public Health in Romania is the Competent Authority to control the marketing, database of notifications, inspections, public information, registration of adverse reactions cases and reporting to European Commission.

Article 6- it is forbidden to use certain substances for cosmetics manufacture purposes

Article 7- it is forbidden to place on the market cosmetics that are tested on animals using other methods than alternatives validated in European Union.

Article 12- the process of notification consist of submitting (electronically or in hard copy)to the Ministry of Public Health of following information:

• Name of the manufacturer, or his agent ,or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product on the Romanian market their registration number

• Romanian residence of the manufacturer or importer

• Country of origin for cosmetic products manufactured outside Romania

• Invented name of the cosmetic product

• The function of the cosmetic product

• Conformity declaration by which the manufacturer, or his agent ,or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product on Romanian market are assume responsibilities conformity of the cosmetic product with Romanian legislation

Article 13- The Ministry of Public Health should have public the list with all cosmetic products that was received notification

Article 14- documentation presented of the site that is printed on the cosmetic product label; if there are many sites, should be highlighted where the product dossier in available

Article 15- all data in the dossier should be presented into Romanian language or into a international language

Article 17- information on immediate packaging and the outer packaging: name and address of the producer, or his agent ,or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product, country of origin, composition, date of minimum durability, warnings, function of the cosmetic product

Article 18- International Nomenclature for Cosmetic Ingredient (INCI) is used for ingredients names and Color Index for coloring agents

Instructions for applying the law no.178/2000 amended by 379/2004

Article 3 - the notification should be granted by the Ministry of Health or local subsidiary according to the address where the dossier is found; if within 10 day it was not communicated any issue, the product could be marketed

Article 8 - into ingredients list, those for which the confidentiality was accepted should be printed as a 7 numbers code

Annex 2 - the content of the dossier:

Commercial name of the product
The type of the cosmetic product
Qualitative and quantitative composition
Physico-chemical and microbiological characteristics of raw material and the finished product
Manufacturing method
Method for qualitative analysis
Product stability
Assessment of risk for public health
Name and address of testing laboratory
Name and address for person who evaluated the product
Side effects registered by importer from consumer
The proof for declared effect – in vivo or in vitro tests