“a value driven approach to regulatory compliance…”
Classification, Labelling and Packaging Jonathan Lutwyche h h Thursday 17th June 2010
INTRODUCTION TO CLP: CLASSIFICATION, LABELLING AND PACKAGING CLASSIFICATION, LABELLING AND PACKAGING REGULATION (1272/2008)
WWW.THEREACHCENTRE.COM
CURRENT/OLD EU SYSTEM
The current EU system on classification, packaging and labelling of chemicals h i l has h been b d l developed d over the h last l 40 years and d is i set out in three key instruments • the Dangerous Substances Directive (67/548/EEC) • the Dangerous Preparations (i.e. mixtures of substances) Directive (1999/45/EC) • REACH Annex II ((EC) 1907/2006); originally the Safety Data Sheet Directive (91/155/EEC)
WWW.THEREACHCENTRE.COM
WHAT IS CLP?
• New EU Regulation on Classification, Labelling and Packaging of substances and mixtures (CLP) • Implement GHS into EU • Entry into force 20 January 2009 • Scope • substances and mixtures including C&L of Plant Protection Products and Biocides • certain specific articles(explosive article)
WWW.THEREACHCENTRE.COM
WHY IS THE GHS IMPORTANT? EExample Substance ‐ l S bt l t i it LD50 = 257 mg/kg 257 /k oral toxicity LD GHS/CLP Danger (Skull & Crossbones) Transport EU US CAN Australia India Japan Malaysia Thailand New Zealand China Korea
CLP – PRINCIPLES (1) • Replacethe DSD (67/548/EEC) and DPD (1999/45/EC). • Takes up all GHS Hazard Classes • But does not include all GHS categories i.e. • Flammable liquids category 4 • Acute Toxicity category 5 • Skin corrosion/irritation category 3 • Aspiration hazard category 2 Aspiration hazard category 2 • Acute aquatic toxicity category 2 • Acute aquatic toxicity category 3
WWW.THEREACHCENTRE.COM
EXAMPLE: ACUTE TOXICITY GHS No Symbol
1
2 5
3 50
300
25
T+
5
2.000
200
T
Not contained in CLP
4
5.000
2000
Xn
EU
Health Hazards: e.g. acute oral toxicity (mg / kg)
WWW.THEREACHCENTRE.COM
CLP SCOPE •
CLP is similar to the current EU system:
•
CLP is different to the current EU system:
•
It provides one single system for hazard classification and labelling
•
•
It covers approximately the same hazards
•
•
It often uses similar or equal It often uses similar or equal classification criteria
It sets criteria for both transport and supply, and use It defines different hazard classes and categories It uses partly other criteria and other cut‐offs It uses a different approach for mixtures It changes some labelling elements
•
It sets up an equivalent system of h hazard communication
CHANGES Indication of danger (= Signal word) EU ‐ IRRITANT CLP – WARNING CLP –
Risk Phrase (= Hazard statement) EU ‐ Irritating to eyes EU Irritating to eyes CLP ‐ Causes severe eye irritation
S f Safety phrase (= Precautionary statement) h ( P i ) Keep out of reach of children Do not breath dust In case of contact with eyes, rinse immediately with water and seek medical advice
WWW.THEREACHCENTRE.COM
‘Old’ C&L Pictogram
Symbol
Indication of danger
GHS/CLP /
Explosive Extremely/very flammable Oxidising Very toxic/toxic C Corrosive i Harmful/irritating Dangerous for the environment
Risk phrase
R##
Safety phrase
S##
Signal word
Danger Warning g
Hazard statement
H### EUH###
Precautionary statement
P###
WWW.THEREACHCENTRE.COM
C&L NOTIFICATION The following substances will have to be notified to the C&L Inventory: • Substances subject to REACH registration (≥ 1 t/y) and placed on the market. Notification is not necessaryy where a manufacturer,, importer p or OR has already registered the substance; • Substances classified as hazardous under CLP and placed on the market irrespective p of the tonnage. g This includes substances which are classified as hazardous under CLP, but which are exempted from registration, e.g. polymers referred to in REACH Article 6(3); • Substances classified as hazardous under CLP and p present in a mixture above the concentration limits specified in Annex I of CLP or as specified in Directive 1999/45/EC, which results in the classification of the mixture as hazardous, and where the mixture is placed on the market irrespective of the tonnage.
WWW.THEREACHCENTRE.COM
C&L INVENTORY: NOTIFICATION Timing: practice before 24 December ⇒ byy 3 Januaryy 2011,, in p 2010 (for those already placed on the market) ⇒ thereafter within 1 month of placing on the market • Notification by M or I or groups thereof (not OR or non‐ EU exporter)) • Industry (registrants and notifiers) to agree ‘harmonised’ harmonised C&L using CLP criteria • If you have registered the substance no need to notify
WWW.THEREACHCENTRE.COM
METHODS TO NOTIFY 1. Using IUCLID5 2. On‐line submission tool • Reduced number of fields • Use of defaults • Link to the C&L Inventory 3. Bulk submission using XML files. Some limitations: • Must have a CAS or EC # • Single composition • No ‘M’ factors or specific concentration limits possible WWW.THEREACHCENTRE.COM
C&L INVENTORY • All C&L notifiers would receive a submission report which can be copied to group members to show compliance • C&L Inventory to be publicly available on ECHA website • Each notification will require up to 200 data fields to be completed so cooperation (group submissions) highly recommended • Nothing in CLP asks for mixture information • What was not dangerous before REACH and CLP may be hazardous now WWW.THEREACHCENTRE.COM
PROBLEMS?
• Lack of experience with CLP criteria • High demand for CLP expertise • Equivalence tables in CLP putting you the ‘wrong’ side of the classification ‘line’ as far as REACH (and other legislation?) duties are concerned • Preparation of, and notification for, C&L Inventory
WWW.THEREACHCENTRE.COM
Introduction to Classification, Labelling and Packaging Introduction to Classification, Labelling and Packaging £95 per person // Thursday 1st July 2010 // The Heath, Runcorn This course will introduce you to the new Classification, Labelling and Packaging (CLP) regulation which sets out the new requirements for the classification, labelling and packaging of chemical substances and mixtures. The course will be presented by Andrew Fasey, who was a member of the drafting group which The course will be presented by Andrew Fasey who was a member of the drafting group which prepared the GHS and was responsible for preparing the ground for the implementation of the GHS within the EU.
TOPICS INCLUDE TOPICS INCLUDE • • • • • • • •
What we have now: the existing system Why change? How the GHS developed EU i l EU implementation t ti Elements of the GHS/CLP Links between CLP and REACH Timing H How to prepare your company for CLP t f CLP
Book online: www.thereachcentre.com/introductiontoclp
