News Summary

Marketing: Customer Care Technical Note

September 9th 2015

Ref:
TN 01-2015-EN

Memo:
Updating of the labelling of SENTINEL products according
to the CLP regulation (EC) N. 1272/2008



CLP Introduction :
The CLP is the European regulation governing the
classification, labeling and packaging of hazardous
substances and mixtures.

DPD
1999/45/CD
CLP
(CE) N. 1272/2008




The CLP Regulation ensures that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union through classification and labelling.

Starting from June 1st 2015 CLP is the reference regulation for the classification, labeling and packaging of mixtures.

For detailed information related to the CLP regulation,
visit the website :
http://echa.europa.eu/web/guest/clp-2015

Overview
SENTINEL has carried out an updated assessment of the level of danger of their products, based on the classifications imposed by new regulations and has reviewed the following labeling documents of: Instructions for Use (IFU), Safety Data Sheets (MSDS) and Labels.
On the abovementioned documents, the new classification with their pictograms has been introduced.
The kits requiring such changes and which will be manufactured after the June 1st 2015, will have contain the new IFU as well as being identifiable by means of a yellow label warning sticker on the outer packaging of the kit.
Inside the kits there will be an additional sheet that will highlight the adaptation to the CLP regulation to alert the user to this change..

Products
Below you can find the list of updated products.
For details about the types of hazard and precautionary statements, refer to the new IFU or their respective SDS, which can be downloaded from the website http://www.sentineldiagnostics.com/it/login by logging on to the private::

Description Old Labelling CLP Labelling
Acid Phosphatase ND
Albumin Liquid ND
ALP Liquid Xi
ALT UV Liquid ND
AST UV Liquid ND
Bile Acids TBA NP
Bilirubin Direct Liquid ND
Bilirubin Total Liquid Xi
Calcium Liquid ND
Cholinesterase Liquid ND
CK-MB Liquid ND
CK-NAC Liquid ND
Copper ND
Copper Urine ND
Creatinine Liquid Xi
Dibucaine CHE Liquid ND
Fructosamine Liquid ND
Iron Liquid Xn
Lithium C
Phosphorus Xi
Total Proteins C
Zinc ND

ND: Not Dangerous



Glossary

SDS: Safety Data Sheet.
IFU: Instructions for Use.
Labelling: Product configuration including code, description, IFU, SDS, labels and packaging (primary and secondary).
CLP: Regulation (EC) N. 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.
DPD: Dangerous Preparations Directive 1999/45/EC
DSD: Dangerous Substances Directive 67/548/EEC.
REACH e Regolamento REACH: Regulation (EC) N. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals.
ECHA: "European Chemicals Agency," also known as "the Agency," established under the REACH Regulation

We remain at your disposal for any further information and the opportunity is appreciated to thank you for choosing our products. With our best regards.


Andrea Cugini
PS Customer Care Marketing Team

Mario Fangareggi
Marketing Direction










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