Registrations

Vitae Naturals is registered in the Spanish Food Safety Agency (AESAN) and has its Health Certificates for the different manufactured products.

 Health Certificate 26.10361 TO

 Health Certificate 31.01833 TO

 

As it is stablished by the Spanish regulation, the Health Certificates Registration means that the manufacturing company must develop a HACCP plan (Hazard Analysis and Critical Control Points) that guarantees food security of the manufactured products. Vitae Naturals has carried out an exhaustive HACCP plan which is mainly based on the premises stablished by the Codex Alimentarius (and other food standards such as BRC, IFS, etc.) and it provides a detailed Risks Analysis that includes the Critical Control Points that exist in the production process.

 HACCP 

 

It is worth highlighting that two of Vitae Naturals's products have an approved health claim under Regulation (EC) No 1924/2006.

1. According to article 14, paragraph 1, letter a): reduction of disease risk claims, foods that contain our Vitasterol® (phytosterols and sterified sterols) can include on their label the following health claim:

 “Plant sterols have been shown to lower blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease (CHDI)” 

2. According to article 13, it has also been approved a Health Claim for foods enriched with vitamin E (Vitapherole®):

 "Vitamin E contributes to the protection of cells from oxidative stress" 

 

Vitae Naturals is a company registered in the US Food and Drug Administration (FDA) as a producer of food ingredients and additives from 2013. This registry is guaranteed by exhaustive site audits. Last April 2014, the US FDA carried out the first inspection at our facilities where also the Spanish Health Authorities attended.

 FDA

 

Vitae Naturals is a member of the SEDEX platform in order to manage ethical and social responsibility practices throughout its supply chain. Vitae Naturals has been subjected to ethical trade audits of type "SMETA 4-Pillars" based on the Ethical Trading Initiative ETI Base Code with positive results.

SEDEX

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's products are highly demanded in this sector, we have considered that Vitae Naturals's 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's products covered by this consortium are the following ones:

    "Vitapherole E" range      (d-alpha tocopherol)

    (CAS Reg No: 59-02-9)

     

    "Vitapherole E acetate" range      (d-alpha tocopheryl acetate)

    (CAS Reg No: 58-95-7)

     

    Nowadays, the dossier for the authorization for these two products has been handed in and the EFSA has issued a favourable opinion about it.

    In addition, as the final step in this process, the European Commission has also approved the authorization that allows the Authorization for 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 consortium collaborating in the preparation of the registration dossier. The product of Vitae Naturals covered by this consortium is the following:

     

    "Vitapherole T" range      (mixed tocopherols)

    (CAS Reg d-alpha, beta-gamma, delta No: 59-02-9, 16698-35-4, 54-28-4, 119-13-1)

     

    At the moment, the dossier for the authorization approval for this product has been handed in and the EFSA has issued a favourable opinion for this authorization.

    Vitae Naturals is waiting for the European Commission approval so that the use of mixed tocopherols would be authorized as additive in the feed sector.

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:

 

"Vitapherole E" range      (d-alpha tocopherol)

(CAS Reg. No: 59-02-9)

 

"Vitapherole T" range      (mixed tocopherols)

(CAS Reg d-alpha, beta-gamma, delta No: 59-02-9, 16698-35-4, 54-28-4, 119-13-1)

 

"Vitasterol S" range      (mixed phytosterols)

(CAS Reg Campesterol, Stigmasterol, Beta-Sitosterol, Beta-Sitostanol No:474-62-4,83-48-7,83-46-5, 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 substances affected by the regulation. Pre-registered substances 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

 

Thanks to this pre-register our customers can keep on using our products until the registration will be completed.
 

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. Since the end of 2011 Vitae Naturals has been involved in the development of a registration dossier for mixed phytosterols ("Vitasterol S" range). Due to this, Vitae Naturals is working intensively together with other companies of the sector, through a consortium which has been specifically created for this issue.

In September 2013 Vitae Naturals proceeded to carry out the Reach Registration for mixed phytosterols ("Vitasterol S" range).The registration dossier has been sent to the European Chemicals Agency (ECHA) for its evaluation and final approval.

Vitae Naturals already has a registration number for this product.

 

4. 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.