Registrations
FEED SECTOR:
The Regulation (EC) No 1831/2003 establishes a Community procedure for the authorization of the commercialization and use of feed additives in the feed sector. Since some of Vitae Naturals' products are highly demanded in this sector, we have considered that Vitae Naturals' participation in various consortia was necessary, so that we would be able to proceed to register and submit a single application together with other manufacturers and distributors of the sector for authorization. This participation does not only imply a great economic effort supported by Vitae Naturals, but also the membership to a number of consortiums where the needed information for the authorization of its products as feed additives are discussed and focused.
Nowadays Vitae Naturals participates in two consortiums that are working to achieve the registration of our products:
1.VITAC (Vitamins Authorization Consortium):
This consortium was founded in 2007 and Vitae Naturals took place in it until December 2010, providing its products data and working on the preparation of the Registration dossier. Vitae Naturals' products covered by this consortium are the following ones:
- d-alfa tocoferol; CAS Reg. Nº: 59-02-9
- d-alfa tocoferyl acetato; CAS Reg. Nº: 58-95-7
Nowadays, the dossier for the authorization has been handed in and the EFSA has issued a favourable opinion about it. In addition, The European Commission has also approved the authorization that allows the use of Vitamin E as a feed additve for all animal species (Regulation (EC) No 26/2011).
2. ANTOXIAC (Antioxidants Authorisation Consortium):
Likewise, Vitae Naturals takes place in this cosortium collaborating in the preparation of the registration dossier. The product of Vitae Naturals covered by this consortium is the following:
- Mixed tocopherols:
At the moment, the dossier for the authorization approval has been handed in. Vitae Naturals is awaiting for the EFSA favourable opinion and for the European Commission approval so that the use of mixed tocopherols would be authorized as additive.
REACH
The main aim of the Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of CHemicals (REACH), is to regulate the commercialization of chemicals in the European Union. The products manufactured and commercialized by Vitae Naturals covered by this regulation are the following ones:
- d-alpha tocopherol; CAS Reg. Nº: 59-02-9
- mixed tocopherols; CAS Reg d-alfa , beta-gamma , delta. Nº: 59-02-9 ,16698-35-4 ,54-28-4 ,119-13-1
- mixed phytosterols; CAS Reg: Campesterol 474-62-4; Stigmasterol 83-48-7; Beta-Sitosterol 83-46-5; Beta-Sitostanol 84-45-4
All these products are marketed in the cosmetic industry, which is affected by REACH regulation. At the moment, Vitae Naturals meets completely REACH regulation since it has been carrying out its requirements within the deadlines.
1. In 2008 Vitae Naturals proceeded to pre-register the products affected by the regulation. Pre-registered products are:
a.Product: d-alpha tocopherol
Pre-registration number: 05-2117222301-65-0000
Registration deadline: 31/05/2018
b.Product: mixed tocopherols
Pre-registration number: 05-2117117722-51-0000
Registration deadline: 31/05/2018
c.Product: mixed phytosterols
Pre-registration number: 05-2117220658-42-0000
Registration deadline: 31/05/2018
This means that our customers can continue using our products until they will be definetely registered.
2. In 2010 Vitae Naturals proceeded to carry out the Notification on Classification, Labelling and Packaging of the previously listed substances under Regulation (EC) No 1272/2008 (CLP)
3. In its role as a downstream user, Vitae Naturals cooperates with its suppliers ensuring that raw materials and other substances used in the manufacture process of its products meet the requirements of REACH.
On the other hand, it is important to emphasize that Vitae Naturals has been inspected by the Ministry of Health on REACH matters, verifying the complete compliance with its duties under that Regulation.