CLP: the Classification, Labelling and Packaging regulation
Introduction Before chemical products are placed on the market, they need to be • Classified • Labelled • Packed according to the applicable legislations and regulations As a result of a new European regulation, there will be changes to the way chemical hazards are calculated and communicated into the market through labels and Safety Data Sheets The goal of this presentation is to help you understanding the changes and the impact of this new European regulation
Regulatory background
What is GHS? GHS stands for Globally Harmonised System of Classification and Labelling of Chemicals • A United Nations project that began with a mandate from the 1992 Earth Summit Objective was to: • Enhance the protection of human health and the environment, while minimizing changes • Provide an internationally harmonized and comprehensible system for hazard classification and hazard communication • Reduce the need for animal testing and evaluation of chemicals • Facilitate international trade
What is GHS? GHS provides countries with a free building block approach to develop or modify existing programs • Jurisdictions can choose which parts to implement, can add extra requirements and can change assessment rules • Classification of substances and mixtures therefore not harmonized across jurisdictions
Free building block approach will lead to a non-harmonized world-wide adoption of the GHS Europe has adopted the GHS and therefore it has become a regulation: CLP
What is CLP? CLP is the regulation on Classification, Labelling and Packaging of substances and mixtures • Is the European implementation of the UN-GHS • Uses REACH findings on substances and translates into mixtures • CLP regulation (EC)No 1272/2008 will replace the current Dangerous Preparations Directive (DPD) Directives were implemented in each member state through national legislation, now being replaced by a new directly acting Regulation
• Impacts all chemical products except Cosmetics
Key changes: • New and much stricter hazard calculation rules will result in more products to become hazardous • New requirements for labels and Safety Data Sheets • Transport packaging now also requires CLP labelling, when not classified by transport (ADR)
CLP (EU) implementation timeline June 1st 2015 • CLP classification, labelling and SDS required for all products • EX-FACTORY, it is not allowed to produce any non-CLP compliant chemical as from this date
June 1st 2017 • There is a sell-out period of 2 years for existing stock. It is not allowed to trade/ship any non-CLP compliant chemical as from June 1st 2017 • This timing also applies to distributors • Any remaining stocks require relabelling • Products in storage and/or use by end-users are not affected by these deadlines and may be used beyond that deadline
Changes & Impact
Impact of CLP on chemicals Re-evaluation and classification according to new and stricter calculation rules Hazard classification change for many products, mostly to be more hazardous • Potential impact on transport classifications
New labels with new hazard symbols and new Hazard & Precautionary phrases • More text in all languages and diamond shaped symbols • Text on label need to be identical in all languages (no country specific translation/interpretation)
New Safety Data Sheets with CLP classification and labeling information
Hazards and pictograms Physical Hazards
DPD symbol
Health Hazards
• Explosives • Self-Reactives • Organic Peroxides
•Acute Toxicity (fatal or toxic)
• • • • • •
• • • • • •
Flammables Pyrophorics Self-Heating Emits Flammable Gas Self-Reactives Organic Peroxides
• Oxidizers
• Gases Under Pressure • Corrosive to Metals
Carcinogen Mutagenicity Reproductive Toxicity Respiratory Sensitizer Target Organ Toxicity Aspiration Toxicity
• Skin corrosion/burns • Eye damage • Irritant (skin and eye) • Skin Sensitizer • Acute Toxicity • Narcotic Effects • Respiratory Tract Irritant
Remark: Most relevant hazards for Sealed Air products are listed in bold
DPD symbol
OR
Hazards and pictograms Environmental Hazards
DPD symbol
• Acute aquatic toxicity • Chronic aquatic toxicity
•
Dangerous for the ozone layer
(not part of UN GHS)
Remark: Most relevant hazards for Sealed Air products are listed in bold
Hazards and pictograms Did you know? •
Products will not change straight from the DPD symbol to the similar CLP pictogram as the new and stricter calculation rules under CLP often lead to a different and/or new hazard classification (and pictogram)
•
The hazards on the label refer to the hazards of the concentrated product •
In many cases the hazard does not apply anymore once the product has been diluted to the concentration of the inuse-solution
•
Chemical products can have hazards from different categories, thus more than 1 picto
•
Pictograms can cover different hazards
•
The possible routes of exposure are important to determine if a product can be used safely or not
•
The new CLP rules result in more detergents being classified as irritant or corrosive to skin/eye
•
More products will get the flammable symbol under CLP •
•
Under DPD those products were already classified as flammable but without a DPD symbol on the label
On single packaging suppliers may omit CLP hazard pictograms if they duplicate the transport pictogram
Important changes in hazard classification of cleaning, maintenance and disinfection products Stricter classification rules Not classified → irritant to skin or eye
(H315, H319)
No pictogram →
• Typical for all mixtures containing 1 - 3 % surfactants • Will be a ‘given’ for any detergent under CLP
More corrosive labelling • Irritant to skin (R38) → corrosive to skin (H314) • Irritant to eye (R36) → serious eye damage (H318) • Typical for all mixtures containing > 3 % surfactants
→
Important changes in hazard classification of cleaning, maintenance and disinfection products New pictograms Not classified → Corrosive to metals
(H290)
No pictogram
→
No pictogram
→
No pictogram
→
• Hypochlorite, acids/bases
‘Flammable’ (R10) → Flammable (H226) • Flammable with symbol under CLP
Not classified → Aquatic chronic toxicity •
Relevant for surfactants
(H410, H411, H412)
Important changes in hazard classification of cleaning, maintenance and disinfection products Other new hazard classification criteria R65→ Harmful by aspiration
(H304)
• Mineral oils, pinene/limonene >10 %
Specific Target Organ Toxicity (STOT) • R67→ Vapours may cause drowsiness and dizziness (H336) o Warning symbol under CLP o Alcohols, pentane, heptane, acetone >20%
• Not classified→ may cause respiratory irritation (H335) • Not classified→ variants of ‘causes damage to organs’ (H370, H371, H372, H373)
New label requirements under CLP DPD • Symbols • Indications of danger • Risk phrases • Safety phrases
CLP • Pictograms • Signal word • Hazard phrases • Precautionary phrases
Danger Warning Will require more text in all languages!
• Additional labelling requirements • Supplemental labelling information • ‘Safety data sheet available on request’ required on label for non classified products for professional users. • Hazardous ingredients to be specifically mentioned • Same text in all languages / countries • CLP label also required on transport packaging (if not ADR)
More details on label requirements The signal words indicate the severity of the hazard: • Warning: less severe hazard • Danger: more severe hazard Hazard & Precautionary phrases • Hazard phrases describe the type of hazard and the severity of the effect • Precautionary phrases are recommended measures that help to prevent and minimize the exposure where necessary and are directions on how to respond to accidents • Always check the SDS for further safety requirements as precautionary phrases on the label will be limited to the most relevant ones Supplemental labeling information • Information related to other legislations which need to be mentioned on the label
Example of a CLP label 3 7
5
2 Product identifier,
1
2
1 Hazard pictogram
Trade name of chemical
6
3 Name and address of the manufacturer/supplier
4 Telephone number of local sales company
4 8
5 Signal word 6 Hazard and Precautionary phrases
7 Hazardous Ingredients Table (max. 4 hazardous ingredients)
8 Supplemental labelling information Comment: Only example of label; Does not represent the final label
Safety Data Sheets (SDS) The Safety Data Sheets will be adjusted to include *: • • •
CLP classification and labelling information in section 2 New mixture and substance toxicity data in section 11 Minor changes is other sections
Until 1st June 2015 the new SDS of products/mixtures will contain both the DPD classifications and the new CLP classifications* As the classification of products - and thus the handling, Personal Protective Equipment (PPE), storage and transport requirements - might have changed due to the new applicable classification rules, it is important to read the new SDS In addition (not CLP related): Change to new Sealed Air logo * Changes is line with Annex II of amendment 453/2010 of REACH (1907/2006)
Most relevant SDS design changes due to CLP New CLP classification and reference to CLP regulation (section 2.1) New label elements: pictograms, signal word, ‘Contains’ statement, hazard and precautionary statements Contains statement in INCI as well as chemical name (section 2.2) Until 1st June 2015 the DPD classification will still be given in the SDS (section 2.2)
Most relevant SDS design changes due to CLP Acute Toxicity Estimates (ATE’s) for mixture included for calculating the acute toxicity classification (section 11.1)
New toxicity data included: information on specific target organ toxicity and aspiration toxicity (section 11.1)
Impact of CLP for you You will receive products with new labels and new Safety Data Sheets • New label requirements • Transport packaging now also with CLP labeling (when not ADR classified) Safety instructions, transport and storage requirements of a product may have changed due to the new classification rules
What do you need to do? • Get familiar with the new pictograms and hazards and get prepared to receive CLP labeled products • Train employees on CLP and make sure employees working with chemicals understand and recognize the new label information • Always read the SDS and the Product Information Sheet (PIS) • • •
Make sure products are used correctly as mentioned in the SDS (section 1.2) Check if the classification has changed and follow safety advice provided on the new label and SDS Check if there is a change in safety instructions, transport or storage requirements
• Evaluate the risk from the use of the product and update workplace risk assessments if necessary • Review and update all classification related documentation: workplace hazard communication programs, worker instruction cards, internal trainings, dilution bottle labels, etc.
What do trade partners need to do? Additionally to what customers need to do, trade partners need to be aware that: • CLP labeling is also required on transport packaging (when not ADR classified) • Limited Quantity (LQ) is a transport classification
• In some cases, different storage and transport requirements might apply on products due to new CLP classification • They need to correctly label their outer packaging if they re-pack or combine products
Sealed Air (Diversey) Approach
Our Commitment • At Sealed Air, we are passionate about sustainability, safety and the environment. We are committed to reduce risk, to protect human health and the environment and to support our customers to do the same • We pro-actively evaluate our product ranges against the new CLP criteria and will continue to secure the safety of our products. We will implement the necessary changes before the regulatory deadlines • We want to emphasize that the chemical formulation of our products does not change. However, the hazard classification may be different or more stringent as a result of the stricter calculation rules under CLP but, we can assure the in-use solution remains as safe as before for end-users • Only in a few exceptional cases products will be reformulated to ensure we continue to provide the safest products to our customers. This will be done without compromising quality and performance of our cleaning solutions • We are committed to support and guide our customers during the implementation of CLP
Implementation approach • On our new SDS, we will provide you with the safety measures for the concentrated product as well as for the dilution as those of the dilution are not as severe as for the neat product • CLP SDS will be published when the first CLP labelled product becomes available in the supply chain • A change in transport classification will result in a change of SKU code when implementing CLP •
Other SKU codes changes might be required as a result of e.g. reformulations, SKU migrations
More information needed on CLP? If you want to know more about CLP in general, please visit the site of ECHA (European Chemical Agency (www.echa.eu) or consult our communication material If you have specific CLP questions on Sealed Air products, please contact your local sales representative or our customer service Sealed Air developed a free on-line training module on CLP. If you or your employees are interested, please go to our website