Transforming Our World: Delivering affordable medicines to anyone, anywhere, any day 1 Environmental hazards of substances Annex 1 – Part 4 of CLP Date: Name:

2 CONTENTS 1.Basic elements for classification for aquatic environmental hazard 2.Acute aquatic hazard 3.Chronic aquatic hazard 4.Hazardous to the ozone layer 5.Label elements 6.CLP vs DSD 7.Example

3 BASIC ELEMENTS The hazard class ’Hazard for aquatic environment’ is subdivided into: –Acute aquatic hazard (1 category) –Chronic aquatic hazard (long term) (3 categories + safety net) Basic elements for classification for aquatic environmental hazard: –acute aquatic toxicity (LC/EC 50 ); –potential or actual bioaccumulation = accumulation of a chemical substance in an organism after take-up from the surrounding water or via the food chain (BCF, LogKow) –(biotic or abiotic) degradation of organic chemical substances = how long the substance remains available in the environment (break-up tests after 28 days, incl. OECD 301 (A-F)) –chronic aquatic toxicity (NOECs)

4 ACUTE AQUATIC HAZARD Category 1 96 hour-LC50 (for fish)<= 1mg/l and/or 48 hour EC50 (for crustaceans)<= 1mg/l and/or 72 or 96 hour ErC50 (for algae or other aquatic plants) <= 1mg/l NEW: crustaceans: e.g. Daphnia or mysids! algae also 96 hours and preferably ErC50 (EC50 on basis of the growth rate)

5 No acute categories 2 and 3 according to CLP, but in GHS!! Also in DSD, R51 and R52 do not exist alone Acute aquatic hazard123 Chronic aquatic hazard1234 N/A in CLP ACUTE AQUATIC HAZARD

6 CHRONIC AQUATIC HAZARD Category 1 96 hour LC50 (fish)<= 1mg/l and/or 48 hour EC50 (crustaceans)<= 1mg/l and/or 72 or 96 hour ErC50 (algae or other aquatic plants)<= 1mg/l AND The substance is not rapidly degradable and/or experimentally determined BCF >= 500 (or if this is absent, log Kow >= 4) Category 2 96 hour-LC50 (fish)> 1 and <= 10 mg/l and/or 48 hour-EC50 (crustaceans)> 1 and <= 10 mg/l and/or 72 or 96 hour ErC50 (algae or other water plants)> 1 and <= 10 mg/l AND The substance is not rapidlydegradable and/or experimentally determined BCF >= 500 (or if this is absent, log Kow >= 4) Unless the NOEC (chronic) > 1 mg/l

7 CHRONIC AQUATIC HAZARD Category 3 96 hour LC50 (fish)> 10 and <= 100 mg/l and/or 48 hour EC50 (crustaceans) > 10 and <= 100 mg/l and/or 72 or 96 hour ErC50 (algae or other aquatic plants) > 10 and <= 100 mg/l AND The substance is not rapidly degradable and/or experimentally determined BCF >= 500 (or if this is absent, log Kow >= 4) Unless the NOEC (chronic) > 1 mg/l

8 CHRONIC AQUATIC HAZARD Category 4 Safety net (no classification according to previous criteria but still grounds for concern) e.g. poorly soluble substances which: -Have no acute tox data at maximum solubility AND - Not rapidly degradable AND -Bioaccumulative (BCF >= 500 or, if absent LogKow >=4) Unless the NOEC (chronic) > 1 mg/l or NOEC > then solubility in water, or proof of rapid degradation (cf. previous R53)

9 HAZARDOUS TO THE OZONE LAYER Not included in GHS, but in CLP (GHS-EU): EUH059 DSD : N; R59 A list of clean substances is included in Regulation no. 2037/2000: PB L244 of

10 LABEL ELEMENTS - ACUTE

11 LABEL ELEMENTS - CHRONIC

12 CLP versus DSD Classification as per DSD CLP hazard categoryCLP classification N; R50Aquat.acute 1H400 N; R50/53Aquat.acute 1 Aquat.chron.1 H400 H410 N; R51/53Aquat.chron.2H411 R52/53Aquat.chron.3H412 R53Aquat.chron.4H413 N; R59OzoneEUH059

13 EXAMPLE LC50 (96h) fish: 75 mg/l EC50 (48h) daphnia: 30 mg/l ErC50 (72h) algae: 0.5 mg/l degradability (OECD301): 2 - 4% (not rapidly degradable) Log Kow 2.6 CLASSIFICATION: Pictogram: Classification: Aquat. Acute., category 1 Signal word: Warning Hazard indication: H400 LABEL Signal word: Warning Hazard indication: H410 H400 omitted if H410 Pictogram: Classification: Aquat. Chron., category 1 Signal word: Warning Hazard indication: H410