CLP – The mixtures challenge

Richard Roy REACHReady Technical Advisor Stand RS2 Chemspec Europe 2014

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Your REACH and CLP advantage

What is CLP? • C lassification,L abelling and P ackaging of Substances and Mixtures Regulation 2008 (as amended) • Implements Global Harmonisation System (GHS) • Replaces the DSD and DPD within Europe

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Your REACH and CLP advantage

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Obligations • Classify, label and package substances and mixtures before placing them on the market • Also classify substances not placed on the market subject to registration or notification under REACH (e.g. Isolated intermediates, PPORDs) • Submit notifications to C&L inventory • Keep up to date and update classifications as necessary • Keep records for > 10 yrs after last placed on market • No minimum threshold – includes substances and mixtures 25 - 200

CLP

Cat. 1 Category 2 Category 3 Category 4 ≤5 > 5 - ≤ 50 > 50 - ≤ 300 >300 - ≤ 2,000 mg/kg

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Harmful > 200 - 2000 mg/kg

Your REACH and CLP advantage

Re-classification of mixtures

• Classification should be based upon raw test data on mixture – Most accurate means of classification – Data on most mixtures unlikely to be readily available – Physical hazards: • Obliged to carry out testing if no data available • Can waive testing if none of the ingredients carry physical hazards, and it is unlikely the mixture will.

– Health and environmental hazards • No obligation to carry out new testing under CLP and in vivo data should not be generated. • For CMR effects and certain aquatic hazards, classification cannot be based upon data relating to mixture. www.reachready.co.uk

Your REACH and CLP advantage

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Re-classification of mixtures

• If no data available for mixture, but is available for similar mixtures, ‘bridging’ principles may be used.

• NOTE: Not all bridging principles apply to each class – you must check the relevant section of CLP to see which ones apply to the hazard class you are considering

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Your REACH and CLP advantage

Re-classification of mixtures

• Where no data available for mixture or similar mixtures for a particular hazard class, will need to use an ingredient-based approach • Requires accurate information on individual ingredients from… – – – –

Annex VI to CLP? Classification and labelling inventory? Other public databases? Suppliers safety data sheets?

• Potential inaccuracies if form is changed or new compounds created www.reachready.co.uk

Your REACH and CLP advantage

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Classification based on ingredients • Substances may be assigned ‘specific concentration limits’ for certain hazard classes – In Annex VI where harmonised, on SDS where not? – No longer concentration limits for acute toxicity – M-factors for aquatic toxicity

• For other substances/hazard classes, generic concentration limits to be used – Listed in Annex I to CLP – Some changes from DPD eg • Reproductive toxicant category 1A/1B from 0.5% (R60/61) to 0.3% (H360FD) • Skin/Eye irritant category 2 from 20% (R36/38) to 10% (H319, H315) www.reachready.co.uk

Your REACH and CLP advantage

Classification based on ingredients • As under DPD, some hazard classes are non-additive (ie concentration of ingredient above concentration limit prompts classification) – – – –

skin and respiratory sensitisers; germ cell mutagens; carcinogens; reproductive toxins; specific target organ toxicity, single and repeated exposure; aspiration hazard

• For other hazard classes it is assumed that the contribution made by the properties of each component is proportional to its concentration – Acute toxicity; – Skin corrosiveness/irritancy and eye damage/irritancy; – Aquatic toxicity www.reachready.co.uk

Your REACH and CLP advantage

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Classification based on ingredients • For corrosivity/irritation, equation based on concentration limits used (As under DPD) • Additivity principle will not always apply • Classification applies where: Sum of (ConcA / cIA) + (ConcB / cIB) + … + (ConcZ / cIZ) is ≥ 1 Where • ConcA = concentration of substance A in mixture; • cIA = concentration limit for substance A; • ConcB = concentration of substance B in mixture; • cIB = concentration limit for substance B www.reachready.co.uk

Your REACH and CLP advantage

Classification based on ingredients • For acute toxicity, equation based upon establishing ‘Acute Toxicity Estimate’ for ingredient • Use equation:

100 = ATE mix

∑ n

Ci ATE

i

Where • Ci = concentration of ingredient i (%w/w or %v/v) • ATEi = Acute Toxicity Estimate of ingredient i (%w/w or %v/v) • n = number of ingredients www.reachready.co.uk

Your REACH and CLP advantage

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Classification based on ingredinets • For aquatic toxicity, equations based upon multiplying(M)-factors • If sum of ingredients with same classification multiplied by the M-factor exceeds defined value, classification applied Sum of components classified as:

Mixture classified as:

Acute I x M >25%

Acute 1

Chronic I x M≥ 25%

Chronic 1

(M x 10 x Chronic 1) + Chronic 2 ≥ 25%

Chronic 2

(M x 100 x Chronic 1) + (10 x Chronic 2) + Chronic 3 ≥ 25%

Chronic 3

Chronic 1 + Chronic 2 + Chronic 3 + Chronic 4 ≥ 25%

Chronic 4

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Your REACH and CLP advantage

Re-classification of mixtures

• When data is unavailable to re-classify by one of the other methods, CLP Annex VII translation table can be used – Only allows reclassification for endpoints where there is a reasonable degree of coherence between DSD/DPD and CLP classifications – Not all hazard classes can be translated

LAST RESORT ONLY

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Your REACH and CLP advantage

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Issues for business

• Availability of data • Mixtures within mixtures • Imported products

• Deciding when best to make the change • Education/training of company staff (customer services, sales, etc), distributors and customers • Need to update safety data sheets, technical data sheets, sales literature, websites, etc. so all consistent

• Managing the PR aspects of the change • What do customers do with your product? End use? Formulated into other products? • New/changed classifications acceptable?

• Making the change at minimum cost www.reachready.co.uk

Your REACH and CLP advantage

Thank You!

www.reachready.co.uk [email protected]

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Your REACH and CLP advantage

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