viernes, 11 de diciembre de 2015

Product stewardship - Gestion responsable des produits

Subject: information requested in order to export chemicals from France to Spain.
Sent: Monday, November 23, 2015 4:59 PM

Dear Borja,

Our company is producing pigments and other chemicals in France and we are working with XXXXX XXXXX.
Very shortly, we will have to ship goods to their factory in Spain and we are wondering if we have to make some registrations with you in order to export.

XXXX XXXX asked us to contact poison control center to be ready.
Hope you will be able to help us and answer our question.

Cordialement / Best regards


20 Cours Michelet, 92800 Puteaux, France


Hello, thank you for contacting us.

First of all, let me introduce ourselves, you are writing to AVEQ-KIMIKA, we are a chemical companies association from the Basque Country region, we serve to over 125 associated companies and we offer our services as regular consultants to non-associated companies as well. For your interest, we have been working in regulatory affairs area for the past 15 years, including DSD, DPD, Biocides, REACH and CLP.

Said that, let me clarify how things are going in Spain regarding CLP article 45 notification (regulated in France by Décret 2014-128 du 14 février 2014 and in Spain by Orden JUS/836/2013):

1. Scope: Only mixtures classified as dangerous (health and/or physical categories) should be notified. So, i) substances, ii) not dangerous mixtures and iii) only dangerous for environment mixtures; are exempted.

2. How to notify:

Right now in Spain we got two alternative systems:

a) Ordinary notification: mixtures classified as dangerous (health and/or physical) should be notified to "Instituto Nacional de Toxicología" (INT) following CLP art 45.  This notification includes:

- Label
- Toxicological sheet where full composition should be indicated.

In order to make this notification you should use the software GesFicCom that you can download from INT website.  Each notification is subject to fee payment (30,00€ or less being an SME).

b) Pre-Notification: In the very last minute of last June, authorities gave us a transition period through this regulation:

When mixtures are for industrial use only (REACH SU3), instead of making the ordinary notification you could make a "pre-notification" and you do not neet to make the ordinary notification till 1st june 2017.

In order to make this pre-notification, you need:

- Label
- Excel sheet where the trade names are indicated (in this case, no full composition nor fee applies)

If this is your case (only industrial use) I highly recommend you go this way and forget by now about the ordinary notification, you could find all the information here:

If you find making the pre-notification too complicated, we could send the information on your behalf.

In any case, let me know any question you got,


Mr. Borja Fdez. Almau
Abogado colegiado / Lawyer Bar # 6997
Área de Tutela de Producto - Regulatory Affairs

Gran Vía, 50 - 5º
48011 BILBAO (Spain)

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