Writing in the Official Gazette of Romania, the country’s parliament authorised Law 56/2021 on food supplements (FS Law), in drawn out parliamentary procedures stretching back to 2012.
Central to the legislation are provisions that require prior certification to be granted before food supplements can be placed on the market and only then in pre-packaged form.
Products can only be labelled as ‘food supplements’ with no other designation permitted and with its packaging, advertising and promotional materials complying with specific legal conditions.
Additional provisions include the publishing of certified food supplements on the website of the relevant authority, together with prospectus and label and updated on a monthly basis.
“The FS Law aims to provide, for the first time on the Romanian market, a unitary legal framework in the field of food supplements with respect to single regulation and regulatory body, market placement, advertising and enhanced consumer protection against misleading and counterfeit,” explains Amalia Musat, Senior Associate at law firm DLA Piper.
“The changes are significant in the field as it offers more control to the competent authority to sign-off on the market placement and advertising of food supplements, in view of preventing unfair market practices.”
Fines and penalties
While the Law enters into force at the beginning of this month, it will not become fully effective until the Ministry of Health clarifies the technical details ruling the manufacture, sale and use of food supplements, in which the government also needs to approve, which is expected at the beginning of July 2021.
Once approved, current guidance on food supplements (approved through Order of the Ministry of Public Health no. 1069/2007) will cease to apply.
Further conditions outlined in the FS Law extends towards sanctions that can be metered out in cases that breach these rules.
These include administrative fines ranging between €600 to €3,000 and a temporary or permanent halt in the marketing of the product in question.
Special attention is to be paid to criminal activities in relation to preparing or manufacturing counterfeit food supplements, as well as willingly placing, marketing, selling or distributing counterfeit food supplements on the market, sanctioned under the Romanian Criminal Code.
Transition measures
Law 56/2021 also considers food supplements already on the market, which satisfy FS Law provisions.
These can continue to be marketed without following additional notification process, but the FS Law warned that advertising materials have to be submitted for approval to the country’s Ministry of Health within six months of the start of its implementation.
Products that do not satisfy FS Law provisions can be marketed only until the expiry of the minimum durability date (but not later than 12 months).
This is only if the product does not contain ingredients other than those provided by the FS Law or does not pose a risk to consumers.
The product in question must be labelled in accordance with the legal provisions in force at the time of placing on the market.
Regarding the marketing of food supplements already notified in EU/EEA or imported from third countries, Musat said, “Food supplements already notified in another Member State of the EU/EEA are subject to more simplified procedure of notification to Ministry of Health.
“For food supplements imported from third countries, separate notification proceedings will be detailed in the implementing norms.”