COMMISSION OF THE EUROPEAN COMMUNITIES 
C0MC90) 9 final 
Brussels,8 February 1990 
Proposal for a 
COUNCIL DIRECTIVE 
amending Directive 76/464/EEC on pollution caused by 
certain dangerous substances discharged into the 
aquatic environment of the Community 
(presented by the Commission) 
- Z * 
Proposal for a Council Directive amending Directive 76/464/EEC 
on pollution caused by certain dangerous substances 
discharged into the aquatic environment of the Community 
&XE&AHAXQ&Ï HEflORMUUUL 
On 3 and 4 May 1976» the Council adopted Directive 
76/464/EEC on pollution caused by certain dangerous 
substances discharged into the aquatic environment of the 
Community (1). In this Directive is stated in Article 12 
that the Council shall take a decision (within nine months-
acting unanimously on any Commission proposal concerning 
the limit values and quality objectives of the substances 
from the List I of the Annex to Directive 76/464/EEC. For 
each substance of this List not only the limit values and 
quality objectives were proposed by the Commission and 
discussed in the Council, but also all general legal and 
technical provisions. 
These general provisions were discussed for each substance 
the Council was dealing with. The discussion in the Council 
took very long time. In ten years the limit values snd 
quality objectives for only 3 substances (4 Directives) 
were approved by the Council. 
In order to speed the procedure the Commission proposed a 
"framework" Directive setting out the general legal 
provisions applicable to all the substances in List I in 
the Annex to Directive 76/464/EEC and containing a set of 
general technical provisions in its Annexes. 
CI) O.J. L 129 of 18.05.1976, p. 23 
Z 
- 2 13 
This Directive was adopted by the Council on 12 June 1986, 
as Directive 86/280/EEC on limit values and quality 
objectives for discharges of certain dangerous substances 
included in List I of the Annex to Directive 76/464/EEC. 
Although the mechanism set out in Directive 86/280/EEC 
signified an improvement with regard to the implementation 
of Article 6 of Directive 76/464/EEC the procedure under 
which limit values and quality objectives had to be fixed 
has been assumed not to be swift enough (1). 
During discussions of the first modification (2) to Di­
rective 86/280/EEC on limit values and quality objectives 
for discharges of certain dangerous substances included in 
List I of the Annex to Directive 76/464/EEC in the 
Committee of the Environment, Public Health and Consumer 
Protection of the European Parliament, it was proposed that 
at one stage future additions to the Annexes of Directive 
86/280/EEC be adopted in the Council by qualified majority. 
The Commission did recognise the force behind this id*»a, 
but stressed that on that purpose it would be more 
appropriate to present a single amendment to Article ^2 of 
the framework Directive 76/464/EEC in accordance with 
Article 130S. 
On 12 April 1938 at the Plenary Session of the European 
Parliament the Commission confirmed its willingness to 
amend the framework Directive 76/464/EEC in accordance with 
the wish of the European Parliament and undertook to make 
appropriate amendments in accordance with Article 130S of 
the EEC Treaty. 
one of the conclusions of the Hinisterial Seminar on future 
Community water policy held in Frankfurt on 27 and 28 June 
1988 is as follows : 
(1) O.J. L 181 of 04.07.1986, p.16 
(2) û.J. L 158 of 25.06.1988, p. 35 
"Most delegations urged that, in order to speed up 
progress, the identification of substances to be included 
in the Black List should be decided by unanimity and that 
the values to be subsequently applied should be decided by 
qualified majority following Article 130S, second indent." 
In order to fulfill the obligation following from this 
conclusion the Commission worked out the present proposai 
for an amendment of Article 12 of Directive 76/464/EEC on 
the basis of Article 130S, second paragraph of the EEC 
Treaty, and has requested National Experts to provide it 
with advice on the List of priority substances. 
Such a List has already been requested by the Environmental 
Council at its meeting on 21 March 1988. 
During the meeting of the National Experts on 29 June 1938 
a List of substances was unanimously agreed as the List ot 
priority substances. 
During the meeting of National Experts on 31 January 1V89, 
the Commission stated that insufficient ecotoxicological 
evidence had been found to include 3-Chlorotoluene and 
Chloroprene in the first priority List as proposed by the 
National Experts. 
Furthermore two substances are under discussion in the 
Council and therefore they were also excluded from the 
present proposal. 
II. The Commission suggests that the procedure under Article 
130S second indent shall first be applicable to the 
following list of substances : 
Substances Ecotoxi- Advice of 
cological Technical Scientific 
study study Advisory 
Committee 
1. Trifluralin (124) x 
2. Endosulfan (76) x 
3. Simazine(106) x 
4. Triorganotin comp. 
- Tributyltin oxide (115) x 
- Triphenyltin acetate (125) x 
- Triphenyltin chloride (126) x 
- Triphenyltin hydroxide (127)x 
o, Atrazine* (131) Q 
Organophosphorous substances : 
- Azinphos-ethyl (5) 0 
- Azinphos-methyl (6) 0 
- Fenitrothion (80) x 
- Fenthion (81) x 
- Malathion (89) x 
- Parathion and 
Parathion-methyl (100) x 
- Dichlorvos (70) 0 x 
x 
x 
X 
X 
X 
X 
X 
X 
X 
X 
x = available 
0 = envisaged (available 1990) 
*) Atrazine is not mentioned in the original "List of 129 
substances". The main reason for this was that the use of 
this substance was estimated to be low in EEC Member States 
at that time, 
(this footnote continues on the next page) 
The list is based on the original "List of 129 sub­
stances" (1) and contains four substances and two groups oi 
substances. These substances are chosen mainly on the basic 
of their ecotoxicological properties (toxicity, muta­
genicity, carcinogenicity, teratogenicity, bioaccumuletion 
and persistence) but also the production and figure on use 
are taken into account as well as their presence in i-h\-
Community surface waters. 
For some of these substances the Ecotoxicological and 
Technical studies are already available and for others the 
study is envisaged for the end of 1989 and for 1990. 
Although the advice of the Scientific Advisory Committee ±s 
not yet available for all of these substances, the 
Commission considers that there is already sufficient 
evidence to assume that the substances listed below are 
priority candidates for the following reason : 
*) However, in the last few years it has become obvious that 
Atrazine is extensively used as a herbicide. 
Considering its similarity with Simazine twhich was already 
proposed for the inclusion in the Annexes in Directive 
86/280/EEC) in terms of chemical structure and physical 
properties the Group of National Experts agreed to include 
Atrazine in the List of priority substances. 
(1) O.J. C 176 of 14.07.1982, p. 3 
1. TRIFLURALIR (N° 124) : CAS-1582-09-8 
1 •1 PRODUCTION AMD USE (Réf. 1) 
1.1.1 Production 
The installed production capacity of trifluralin within the 
Community is reported to be 10.300 tonnes/year. The mam 
producers are situated in Italy (3 plants) and Germany (t 
plant). The production capacity in the EEC is estimated to be 
17 % of the world production capacity. 
1.1.2 Use. 
Trifluralin is a key herbicide for weed control. The market, 
after having grown steadily for many years, seems now to be 
relatively steady. The expected growth of annual demand is 
estimated between 1 and 3 %. Worldwide consumption was 
estimated around 25.000 tonnes in 1983,. 
1 • 2 ECOTOXICOLOGICAL EVALUATION (Réf., 2 ) 
Classification of trifluralin is under discussion in the 
Comnittee on classification of existing chemicals (Directive 
67/548/EEC) ( 1 ; . 
1.2.1 Ipx.jçixy, 
1.2.1.1 Acute toxicity 
Despite its low water solubility f<1 mil 1igram.1"' at 27°C> and 
its high absorption potential to soils, trifluralin may pose a 
great hazard to aquatic flora and fauna. 
(1) Council Directive 67/548/EEC of 27 June 1967 on the 
approximation of laws, regulations and administrative 
provisions relating to the classification, packaging and 
labelling of dangerous substances (OJ 196, 16.8.67, p. 1) 
? 
Trifluralin displays very high acute toxicity to 
invertebrates and fish species : aquaLlc 
LCso f48 h:> for P.âRîin.La_jïLaLgiLa. 
LC50 (48 h) for Cvpria (Ostracoda) 
LCso (48 h) for rainbow trout 0,115-0,32 7 milligram.1 
0,06 milligram.I"1 
0,006-0,240 milligram.1 
In contrast to its aquatic toxicity, trifluralin displays low 
mammalian toxicity after acute exposure : 
LD00 for rat (oral) 
LDso for mouse (oral) 
LDso for newborn rat (oral) 5-36 gram/kg body weight 
5 gram/kg body weight 
0,5 gram/kg body weight 
1.2.1.2 Chronic 
The toxicity of trifluralin has been studied in Daphnia magna 
(3 generations). The maximum acceptable toxicant concentration 
iMATO 0,0024-0,0072 mi 11igram.1-1-
Fathead Minnow (Pimephales promelas) (1 life cycle) shows MATC 
of 0,0015-0,0165 milligram.I-1. 
Trifluralin also exhibits high chronic toxicity in marine 
organisms and sublethal effects in one fish species 
(C. variegatvjs) occcured at levels as low as 0,001-0,005 milii-
gram.l"1 (exposure time : 19 months). 
Chronic toxicity data for mammals are insufficient. 
1.2.1.3 Mutag,er>jcj£aU--£.&IlfiJLnQqgn.i_ç.i_£.y and,t_ejr.a_.t,o,g^nJçIty. 
There is insufficient data to evaluate carcinogenicity. IARC 
has not evaluated trifluralin. Although there is some evidence 
for the in vivo clastogenicity in mammals, the confusion caused 
by presence of nitrosamine prevents any firm conclusion. 
Trifluralin exhibits no mutagenic activity in a number of test 
systems (Ref.11). 
At high doses embryotoxicity was observed. 
The substance does not seem to be teratogenic. 
1.2.2 Per si s.t enc„e. 
Trjfluralin is rapidly lost from surface waters and a halt-life 
of less than one hour has been reported. Pho todecompositio* 
appears to be the major route of degradation, but evaporation 
may be of importance under certain conditions. 
Trifluralin in general has persistence in soil between 3-18 
weeks depending on the soil type. 
1.2.3 Bioaccumulation 
Trifluralin is lipophilic and displays high bioconcentration 
factors (up to 5.750 in fish). However, its potential for 
bioaccumulation is constrained by its low persistence in 
aquatic systems, together with a tendency to be adsorbed to 
sediments. 
1.2.4 Ajdj/JLce of the Scientific Advisory Committe_e 
Will be available in March 1990. 
2. ENJ3LQS.UJLEAH (N° 76) : CAS-115-29-7 
2 * PRODUCTION AND USE (Ref. 3) 
2.1.1 Production 
There is only one manufacturer of endosulfan within the EEC. 
The plant is located in Germany and produces about 7.000 
tonnes/year (1986). 
Endosulfan is formulated in Germany (1.500 tonnes/year), France 
» 2.000 tonnes/year), Italy (100-150 tonnes/year), Netherlands 
(30 tonnes/year), United Kingdom (5 tonnes/year), Spain (200 
tonnes/year) and Portugal (4 tonnes/year). 
2.1.2 Use. 
The substance is used in aboriculture, sylviculture and 
agriculture as an insecticide. In the EEC, it is mainly used 
for the cultivation of potatoes, maize, tabac, tomatoes, 
various other vegetables and also in cultivation of fruit 
trees. 
The total consumption is estimated to be 500-c>0C tonnes/year. 
2.2. ECOTOXICOLOGICAL EVALUATION (Ref. 4) 
Classification of endosulfan is under discussion in the 
Committee on classification of existing chemicals (Directive 
67/548/EEC) (1). 
2.2.1 To x..ic.i_t y. 
2.2.1.1 Acute toxicity 
Endosulfan is very toxic to aquatic fauna. Fish are extremely 
sensitive, LCso varying between 0,000.09- 0,004 milligram.!"1. 
For certain crustaceans still lower LCso values were reported 
(0,000.04 milligram.l-M. 
In contrast, endosulfan is moderately toxic to birds and 
mammals. 
LDso for pheasant 50-100 milligram/kg body weight 
LDso for mouse 5-10 milligram/kg body weight 
LD»o for rat 80-110 milligram techn. (in oil)/kg body 
weight 
(1) Council Directive 67/548/EEC of 27 June 1967 on the 
approximation of laws, regulations and administrative 
provisions relating to the classification, packaging end 
labelling of dangerous substances (0J 196, 16.8.67, p. 1) 
10 
2.2.1.2 Chronic toxicity 
Chronic toxicity data for aquatic organisms are insufficient. 
In feeding trials rats receiving 30 milligram/kg diet for two 
years and dogs 30 milligram/kg diet for one year showed no ili-
effect (Ref. 9). 
2.2.1.3 Mutagenicity, carcinogenicity and teratogenicity 
No mutagenic effects were reported. Teratogenicity was reported 
uùth administration of high doses. Endosulfan has been declared 
not carcinogenic. 
2.2.2 P.SX: S_iS.tfiJDLfi.fi. 
It is reported that the half-life in flowing waters varies 
between 4 and 15 days. In contrast, under anaerobic conditions, 
persistence is pH dependent (T 1/2 of 5 weeks for pH = 7 and T 
1/2 of 5 months for pH = 5,5). 
2 . ::. 3 Bioaccumulation 
Bioconcentration factors between 11-2.500 were reported in 
various aquatic organisms. 
2 .2.4 A^vlç,e_..of_„th€ Scientific AdyJjjpj_x_.Çjpjnm ittSLs. 
Mill be available in March 1990-
V 
11 
3- SIHA2IME (N° 106) : CAS-122-34-9 
3. i e&QJVÇTlQH^MLlLJMLfflE. (Réf. 1 ) 
3.1.1 Production 
Installed production capacity is recorded to be 15.000 
tonnes/year. There are 3 production plants in the EEC, situated 
in Italy and the United Kingdom. The exact production figure 
for the EEC is unknown but it is assumed to be 2.500-7.000 
tonnes/year. 
3.1.2 Use 
Simazine is a pre-emergence herbicide used for control of weeds 
in deep-rooted crops, such as citrus, olives, vineyards, 
coffee, tea, cacao. Its major use is on maize. 
Two different sources estimate uses in Europe to vary from 
4.000-7.000 tonnes/year. 
3.2 ECOTOXICOLOGICAL EVALUATION CRef. 2) 
Classification of simazine is under discussion in the Committee 
on classification of existing chemicals (Directive 
67/548/EEC) (1). 
3.2.1 Toxicity 
(1) Council Directive 67/548/EEC of 27 June 1967 on the 
approximation of laws, regulations and administrative 
provisions relating to the classification, packaging and 
labelling of dangerous substances (OJ 196, 16.8.67, p. 1) 
12 
3.2.1 .1 Acute toxicity 
Simazine is toxic to aquatic organisms., Tests have shown a wide 
range of sensitivity for different algae species; toxicity 
levels as low as 0,006 milligram.1"1 are reported for the most 
sensitive species, with most of the data being in the range 
0,1-1,0 mill igram. 1 ~ "• • 
For fish, it was shown to be moderately toxic (96 h LC,0 varies 
between 2,5 and 28,6 milligram.I-1). For one species ( Ro ecu. s 
S.â*<.a.ti..LlS..) an LCso of 0,25 mi 11 igram . 1 ~ "• has been reported. 
Mammalian acute toxicity is reported to be low (LDSo rat / 5 
gram/kg body weight). 
3.2.1.2 Chronic toxicity 
For long term exposures of 8 to 30 days, safe limits ranging 
between 0,1-1 mil 1igram.I"1 were suggested for some aquatic 
vertebrates, although for some sensitive species an LC9o of 
1 milligram.!-1 has been reported. 
Chronic toxicity data are very scarce for mammals. In two years 
feeding studies a no effect level (NOEL) of 100 and 150 
milligram/kg diet were established in rats and dogs. 
3.2.1.3 Mutagenicity, carcinogenicity and teratogenicity 
The studies available seem to show that simazine has no 
reproductive effects, it is not teratogenic, it may be geno-
toxic and no conclusion can therefore be drawn in relation to 
its carcinogenicity. 
3.2.2 Persistence 
Some studies indicate that simazine displays low persistence in 
the aquatic environment, with a short half-life (<1 month). 
However, other investigations report that half-life is 
sufficiently long to result in the accumulation of simazine 
from one season's treatment to the next. 
•f^ 
13 
3.2.3 eipaççutpigqUQn 
Sima2ine has a low bioconcentration factor (<i-55) and in 
general is not expected to accumulate in aquatic organisms. 
3.2.4 Advice of the SçjenUJLic-. Advisor.y ÇflJmLtt&fi. 
The advice on Simazine was delivered on 28 March 1988 (Pef. 
CSTE/88/17/COM) and confirms the decision to include this 
substance in List I. 
4. IJRXQB! IMPOUNDS 
TRIBUTYLTIN OXIDE <N° 115) 
TRIPHENYLTIN ACETATE (N° 125) 
CHLORIDE (N°126) 
HYDROXIDE (N°127) CAS-56-35-9 
CAS-900-95-8 
CAS-639-58-7 
CAS-76-87-9 TPhTAc ) 
TPhTCl ) 
TPhTOH ) 
These substances will hereafter be called 
collectively TPhTs. 
4. 1 PROPUÇTION ANP USJ, (Study will be available at the end of 
1989) 
*.1.1 Production 
The EC production of all tributyltin compounds (including 
tributyltin oxide) was estimated in 1986 as being 3.500 tons. 
According estimation from industry the production of 
triphenyltin compounds (including triphenyltin fluoride) 
reached the last years 2.500 tons/year. 
14 
4.1.2 Use 
Tributyltin oxide has a major use as a biocide and is used in 
wood preservatives (20 %) and particularly in antifouling 
paints (70 %) . The netto counted EEC use in 1986 was 2.500 
tons. 
Potential new uses have been reported in the area of tropical 
disease control. 
TPhTs are used in agriculture (745 - 1.680 tons in 1987) and as 
an antifouling agent (quantity estimated was 100 tons/year). 
TPhTCl is also used as intermediate for the production of 
TPhTOH and TPhTAc. 
4.2 ECOTOXIÇQlfQgIÇAL EVALUATION (Ref. 5, 6) 
A.2.1 Toxicity 
4.2.1.1 AcutQ toxicity 
Tributyltin oxide is highly toxic to various aquatic biota. At 
0,0001 milligram.!"1 it is reported to inhibit the growth of 
algae Skeletonema costatum. 
In Pacific oyster spat (Crassostrea giaas) metabolic effects 
are reported down to 0,000.01 milligram.I"1. 
Uith fish, LCso values generally range from 0,02-0,06 
milligram.I"1 • 
Tributyltin oxide has an acute oral LD»o for rats of the order 
of 150-250 mg/kg body weight. However, low doses in the diet of 
rats affect the immune system, with atrophy of the thymus and 
lymphoid glands. Similar phenomena have recently been reported 
in fish. 
if 
15 
TPhTs are also highly toxic to aquatic organisms. Inhibitory 
effects on algal metabolisms occur down to ca. 0,001 milli­
gram . 1 "1 . 
For freshwater molluscs, LCso range between 0,02 and 0,4 
milligram TPhTs l"1 and for Crustacea from 0,01 to 0,08 
milligram TPhTs l-"1. For fish, LC»0 of below 0,4 mil 1 igram. i -1 
are reported for TPhTAc, and for TPhTOH of below 0,1 
milligram.1~1. 
The acute oral LD8o of TPhTAc for rats is 0,1-0,5 gram/kg bodv 
weight and probably similar for the other TPhTs. 
4.2.1.2 Chronic toxicity 
Mussel larvae (Mvtilus spp.) are reported to have an LCso 15 
days as low as 0,0001 milligram.1~1 towards tributyltin oxide. 
Long-term toxicity data for TPhTs are lacking. 
4.2.1 .3 Mt-âafi.aiç-i.t.y_.â—SArç inftflfijaIsily and tfi.uat.Q.g.a..alc 1ty. 
There are no reports of carcinogenisis, no evidence of 
teratogenisis and no conclusive evidence of mutagenisis action 
with tributyltin oxide. 
From reported data it would appear that there is no conclusive 
evidence that TPhTs are either carcinogenic or mutagenic. There 
are no data for teratogenicity. 
4.2.2 Persistence 
Organotins are degraded by hydrolysis, oxidation, photolysis 
and biota, but the half-life is dependent upon the presence of 
microflora and ranges for tributyltin oxide in natural waters 
from 4 days to 35 weeks. 
4.2.3 Bioaccumulation 
The occurence of bioaccumulation of tributyltin oxide in 
aquatic organisms has been established. Bioconcentration factor 
ranges from 1.000-10.000 between differing species and from 
500-4.400 between differing organs. 
4C 
16 
TPhTs should be considered as moderately bioaccumulative. 
4.2.4 Ad y ic e .....o.f Lh..e._..Sçi.e„n.ti..f,i..c Advisory Committee 
The advice on tributyltin oxide and TPhTs was delivered on 27 
October 1988 (Ref. CSTE/88/41/COM and CSTE/88/61/COM respec­
tively) and confirms the decision to include these substances 
in List I. 
5. ATRAZINE (N° 131) : CAS-1912 - 24-9 
5.1 PRODUCTION AND USE (Study will be available at the end of 
1989) 
5.1-1 Production 
Atrazine is/or can be produced by four plants in Europe . 
The formulation (mixing of active ingredients with solvents 
and/or inert fillers) of atrazine is carried out by 3-6 
factories in the EEC. 
5.1.2 Use. 
Atrazine is widely used as herbicide in agriculture and for 
non-agricultural applications : 
- in agricultural uses (often confined to a very short period 
of the year), on maize and sorghum; 
- in non-agricultural uses to control weeds on roadsides and 
railway tracks. 
Data on use are lacking. 
•f 
17 
5.2 EÇQTQX;iC01,QgiÇ^I1,„EVAI<yjy^QN. (Study will be available at 
the end of 1989) 
Atrazine is still a matter of discussion in the Committee on 
classification of existing chemicals (Directive 
67/548/EEC) (1). 
5.2.1 Toxicity 
5.2.1.1 Acute toxicity 
The acute toxicity for aquatic organisms is rather high 
Skeietona costaturo 
Daj>hiil.a magi\a_ 
Daphnia magna 
Gamroarus frascatus 
Salmo gairdneri 
(rainbow trout) ECso (48 hours) - growth 0,2^5 
milligram.i"1 
ECso - growth 0,5 
milligram.1"1 
LCso (48 hours) 6,9 
milligram.1~1 
LC»o (48 hours) 5,7 
milligram.i"1 
LCso (24 hours) 12,6 
milligram.l"1 
No effect level (96 hours.» 0,1 
milligram.1~1 
Acute toxicity for mammals is low : 
LDso for rat 2.500-3.000 mg/kg body weight 
LDso for mouse 750 mg/kg body weight 
(1) Council Directive 67/548/EEC of 27 June 1967 on the 
approximation of laws, regulations and administrative 
provisions relating to the classification, packaging and 
labelling of dangerous substances (0J 196, 16.8.67, p. Y) 
/* 
18 
5.2.1.2 Chronic toxicity 
Blueg.i.ll. ECso (long-term exposure) - equilibrium 0,2 milli­
gram . 1" y 
Rat No effect level (2 years) 100-1.000 mg/kg body 
weight 
5.2.1.3 Mutagenicity, carcinogenicity and teratogenicity 
Data are not conclusive on mutagenicity and teratogenicity. 
Preliminary evaluation of data on carcinogenicity indicate that 
the substance can be assumed as not carcinogenic. 
5.2.2 Persistence 
Persistence of atrazine in surface waters is estimated to be 
high (half-life 4,3 months). 
5.2.3 Bioaccumulation 
Bioaccumulation seems to be low. 
5.2.4 Advice of the Scientific Advisory Committee 
In view of the Council Directive 80/778/EEC relating to the 
quality of water intended for human consumption, the Scientific 
Advisory Committee advised on 30.04..1987 that a maximum 
admissible concentration of 0,0001 milligram.I"1 should 
continue to be applied to individual pesticides (e.i. atrazine) 
in drinking water (Réf. CSTE/87/71/COM) as a general principle. 
The advice of the Committee on the environmental impact of 
atrazine on the aquatic environment will be available at the 
end of 1990. 
/1 
19 
QRGANQPHQSPH&BUS SUBSTANCES. 
AZINPHOS-ETHYL 
AZINPHOS-METHYL 
DICHLORVOS 
FENITROTHION 
FENTHION 
MALATHION 
PARATHION AND 
PARATHION-METHYL (N° 
(N° 
(N° 
(N° 
(N° 
(N° 
(N° 5) 
6) 
70) 
80) 
81 ) 
89) 
100) CAS-2642-71-9 
CAS-86-50-0 
CAS-62-73-7 
CAS-122-14-5 
CAS-55-38-9 
CAS-121-75-5 
CAS-56-38-2 
CAS-298-00-0 
6.1 PRODUCTION AND USE (Studies will be available at the end 
of 1989) 
6.1.1 Production 
The estimated EEC production figures are as follows : 
azinphos-ethyl 
azinphos-methyl 
dichlorvos 
fenitrothion 
fenthion 
malathion 
parathion and 
parathion-methyl 550-850 tons/year 
550-850 tons/year 
500 tons/year 
1.000-1.500 tons/year 
11.000 tons/year 
12.000 tons/year 
6.1.2 Use. 
Azinphos-ethvl is used as insecticide on a large range of 
crops. The estimated uses was 150-300 tons/year. 
Azinphos-methvl is used as accaricide with an extensive field 
of action in quantities estimated as being 100-150 tons/year. 
Dichlorvos is a used as a household and fumigant, especially 
against DiPtera and mosquitoes, for the protection of stored 
products, for crop protection against sucking and chewing 
insects and in veterinary applications. For 1989, the estimated 
use in EEC is about 100 tons. 
"•' o 
20 
Fejii.t.r.o_th.ion., is a contact insecticide effective against a wide 
range of pests. The counted use in EEC countries in 1989 is 
< 300 tons. 
The major use of fenthion seems to be the control of mosquitoes 
and midges in tropical countries. Furthermore it is used 
against fruit flies, leaf hoppers and cereal bugs - in EEC 
countries in quantities of 700-1.000 tons/year. 
M.i..l.a.th.ioj[x is an insecticide widely used all over the world to 
control insect pests in agriculture, sylviculture and home 
gardens. It is one of the most important organo-phosphorus 
insecticide employed, the netto counted EEC use is < 1.000 
tons/year. 
Pji..r.â.LbÀo_n and parathipn-methvl are both broad spectrum contact 
insecticides which are used in particular for the control of 
insects on cotton, small grains and vegetables. The use of 
these insecticides in the EEC is counted to be < 2.000 
tons/year. 
6.2 ECOTOXICOLOGICAL EVALUATION 
Azinphos-ethyl (Studies will be available at the end of 1990) 
Azinphos-methyl " 
Dichlorvos " 
Fenitrothion (Ref. 7) 
Fenthion (Ref. 7) 
Malathion (Ref. 8) 
Parathion and (Ref. 7) 
Parathion-methyl 
Classification of these substances is under discussion in the 
Committee on classification of existing chemicals (Directive 
67/548/EEC) (1). 
(1) Council Directive 67/548/EEC of 27 June 1967 on the 
li 
21 
6.2.1 To .x.i_c.i..tyL 
6.2.1.1 Acute toxicity 
According to laboratory studies azinphos-ethvl is very toxic 
to aquatic and terrestrial organisms. 
LCso (24 hours) for fish of several species varies from 
0,001 to 0,1 milligram.1_1 
LCso for crustaceans varies from 0,003 to 0,004 milligram.1~1 
LDso (oral) for rat 12 mg/kg body weight. 
According to laboratory studies azinphos-methyl is also very 
toxic to aquatic and terrestrial organisms. 
LCso (24 hours) for fish of several species varies from 
0,0047 to 8 milligram.I-1 
LCso (96 hours) 0,0004 to 4,3 milligram.!-1 
LCso for crustaceans varies from 0,0001 to 0,05 milligram.1~1 
LDso (oral) rat varies from 11 to 16 mg/kg body weight. 
According to laboratory studies dichlorvos is extremely to.-vic 
to aquatic organisms, especially crustaceans and insects. 
ECso (48 hours) for Daphnia pulex 0,000.06 mill igram. 1~ "• 
No effect level (NOEL-96 hours) for Lepomis macrochirus 0,1 
milligram. I"-1 • 
The substance is very toxic to terrestrial organisms and to 
birds : 
LDso (oral) for rat 56 mg/kg body weight. 
approximation of laws, regulations and administrative 
provisions relating to the classification, packaging and 
labelling of dangerous substances (0J 196, 16.8.67, p. 1) 
22 
According to laboratory studies fenitrothion displays - with 
exception of the groups mentioned hereunder - acute toxicity 
levels for aquatic biota between 1 and 10 milligram.I"1 . Acute 
LCso's for many species or crustacean and insect larvae are as 
low as 0,001-0,010 mi 11igram.1"n; for some fish species 50 % of 
the eggs are killed by exposure 0,06 milligram.1"1 
fenitrothion. Oral LDso's for mammals range from 220 to 1.350 
milligram/kg body weight, birds however are more sensitive 
(LDso's for pheasant and quail range from 70 to i 40 
milligram/kg body weight). 
According to laboratory studies fenthion is toxic to aquatic 
biota. For algae, most groups of inverteorates, fish and 
amphibians, acute toxicities range from 0,1 to 7 milligram.1~1 . 
Crustaceans and insect larvae are very sensitive to the 
pesticide : for many species LCso's and ECso's are 0,0005-0,005 
milligram.I-1 , and even as low as 0,000.02 milligram.!-1 for 
seme species of marine shrimp. LDso's for mammals range from 
100 to 500 milligram/kg body weight (compared with 2 to 28 
milligram/kg body weight for birds). 
According to laboratory studies parathion is very toxic to 
freshwater, estuarine and marine biota. Acute effects occur at 
0,001 to 6 mill igram. 1 "• depending on the group of biota. 
Insects and particularly crustaceans are extremely sensitive to 
acute parathion intoxication. 
The substance is also very toxic to terrestrial mammals; for 
male rats the oral LDso is about 7,6 milligram/kg body weight 
and for females 3,5 milligram/kg body weight. 
13 
23 
The range of toxic concentrations of parathion-methyl is very 
wide. The insects (the target group for the pesticide) are very 
sensitive (acute LCBO range 0,002-0,085 milligram.I"1 but 
crustaceans are even more sensitive (LCso range between 0,0001-
0,05 milligram.I-1). There are no significant differences in 
toxicity between freshwater and marine biota. It is also very 
toxic to terrestrial mammals and man. Average oral LDso's are 
11-16 mg/kg body weight for rats and the lethal dose for adult 
man ingesting this pesticide is less than 1.800 milligram. 
According to laboratory studies malathion has either very low 
toxicity or extremely high toxicity, depending on the 
sensitivity of the aquatic biota. In the freshwater 
environment, the LCBO (96 hours) was found to be as low as 
0,001 milligram. I-*1 for several species of various groups of 
insects and crustaceans. For the zoeal stages of some marine 
crab species the LCso (96 hours) is 0,001 milligram.I"1 . 
Oral LDso's for rats reported in the literature range from 885 
to 1.375 milligram/kg body weight. The lowest dose reported to 
cause a lethal effect to humans was 50 milligram/kg body 
weight. 
6.2.1.2 ÇhrQn,lç,JLoxiçUy 
There were no symptoms of poisoning found in rats receiving 2,5 
milligram azinphos-methvl/kg diet for 2 years. In 90 days no 
intoxication was showed in trial rats receiving either 1000 
milligram dichlorvos per kg diet or 2 milligram azinphos-ethyl 
per kg diet. 
Although no chronic data on aquatic toxicity for dichlorvos are 
available for the most sensitive groups of biota, it is 
presumed, by analogy with experiments with fish larvae carried 
out with dichlorvos, that MATCs are at least one order of 
magnitude lower than acute effect levels; consequently NOEL 
levels to crustaceans and insects are probably at the 10 
nanogram.I"1 or lower. 
?4 
24 
Uith regard to sublethal and chronic effects some fish species 
react negatively to fenitrothion in concentrations of 0,01 
milligram.1 ~ 1 . 
Fenthion' s data based on sublethal doses used in chronic 
toxicity trials indicate that physiological activity can be 
impared at 0,05 milligram.I"1 in fish and even at 0,001 
milligram.I"1 in copepods. 
Chronical exposure induces mortality in rats at doses of 5 
miiligram/kg body weight and reproduction success is influenced 
by doses of 10 milligram/kg body weight. 
In 1-year feeding trials dogs receiving 50 milligram/kg diet 
showed no loss of weight or food consumption (Ref. 9). 
As fas as chronic effects of parathion are concerned, levels 
ranging from 0,0001 up to 0,005 milligram.I"1 are reported to 
be lethal for freshwater crustaceans. For insects, 
concentrations of 0,0002 milligram.I"1 up to 0,002 milli­
gram. I*1 seem to be lethal after 2-3 weeks exposure of the 
organisms. 
In 90-days feeding trials rats receiving 5 milligram of 
parathion-methvl/kg diet showed no symptoms of poisoning 
(Ref. 9). 
Chronic toxicity data on insects and crustaceans confirm the 
susceptibility of these biota to malathion: some fish species 
are affected by chronic exposure to 0,05 milligram.I"1 of the 
insecticide. 
Chronic effects in rabbits were detected at levels of 120 
milligram technical grade malathion/kg body weight. In 21 
months feeding trials, rats receiving 100 mg technical grade 
malathion/kg diet showed normal weight gain (Ref. 9). 
6.2.1 .3 Mu,.tag_,en_jc..ity.,,, __ç_ajçcinpgenjcity and t_exat_pgenIcjty, 
For azinphos-ethyl no data have been recorded for mutagenicity, 
carcinogenicity and teratogenicity. 
25 
25 
For azinphos-roethyl only a few data have been recorded which 
show some mutagenic effects to microorganisms. 
Carcinogenicity tests on rats were negative however there is a 
suspicion of neoplastic effects on mice. 
Following available data fenitrothion does not seem to have 
mutagenic and carcinogenic properties, but has shown to be 
teratogenic to embryos of amphibians at relatively low 
concentrations (0,3-3 mil 1 i-gram. I""1 ) . 
Dichlorvos shows mutagenic properties; dichloroacetaldehyde, 
the major metabolite of dichlorvos in mammals la y.iyo was 
discovered to be mutagenic. Carcinogenicity studies gave mostly 
positive results in short term experiments but was not 
confirmed by long term trials, so the evidence is not 
considered as conclusive to date. Dichlorvos may have a 
(slight) teratogenic potential, though most studies gave 
negative results. 
?..e.Q.th.i.OJCL has no mutagenic potential, but has been shown to be 
able to induce malignant tumors in male mice, but not in 
females, nor male or female rats. The teratogenic potential of 
the compound is only expressed at high doses (e.g. in 
milligram/kg in the offspring of mice). 
M.al„a„t.b^pj[i„ and the intermediate oxidation product malaoxon do 
not seem to have oncogenic or teratogenic potency. Malathion 
has, however, been found to be mutagenic in several types of 
experiments on E. coli and on mammalian cells. 
Convincing scientific evidence showing that parathion is 
carcinogenic or mutagenic is not available, so that further 
studies are desirable. The substance can induce teratogenic 
effects in birds, malformation in mammals and aquatic 
organisms, but only at concentrations above those encountered 
in the environment. 
26 
Experimental data (in mice and rats) on the carcinogenic 
potential of parathion-methvl indicate that the compound is not 
oncogenic (Ref. 10). The mutagenic effects are organism 
dependent (e.g. positive gene mutations were obtained in vitro 
experiments with Ej coli and Saccharomyces cerevisiae and 
negative for S^J^MmuxtUM* • 
Teratogenic effects can be induced in birds and mice, but only 
in very high doses. 
6 . Persistence. 
Az inphos-methyl has a low persistence in surface water (from 
hours to days) and moderate in soil (months). 
Degradation occurs through chemical and biological hydrolysis 
and oxidation. Also photodegradation plays a role. 
Degradation of azinphos-ethyl probably occurs through photo-
degradation and chemical and biological hydrolysis. 
Dichlorvos has a low persistence (half-life in aquatic 
environment range from less than one day to several days). It 
is degraded abiotically (by hydrolysis and by photodegradation' 
and biologically. 
Fenitrothion is rather rapidly (a few days up to maximum i-2 
weeks) eliminated from the terrestrial and aquatic biota by 
photolysis and hydrolysis, but mainly by bacterial degradation. 
Fenthion's elimination from the aquatic environments occurs 
relatively quickly (from a few days to 4 weeks) by photolysis, 
hydrolysis but mainly by bacterial degradation. 
MoLlatjiiojQ is quickly eliminated from the aquatic environment >a 
few days) by hydrolysis. 
In the aquatic environment, parathion and parathion-methyl are 
rapidly degraded by microorganisms (half-lives between 2-8 days 
and 2-4 days respectively). 
it 
27 
6.2.? BjLO^.cçum.u.la^loj\. 
Bioaccumulation data for azinphos- ethyl and azijipho^^iethyl on 
aquatic organisms are not reported in the literature. The 
bioaccumulation factors for these substances calculated (from 
log P) are 3.000 and 400 respectively. 
The bioaccumulation factor for dichlorvos is low (log Pow 
1,5£*, which would exclude the possibility of serious 
accumulation in organisms. 
Fejii trothLoiL bioaccumulates to a moderate extent, but 
depuration is relatively rapid (a few days) when contamination 
c eases. 
Despite its high bioaccumulation potential, fenthjpn is not 
considered to accumulate in the aquatic food chain, because of 
its rapid metabolization by plants as well as animals. 
M.Al.at.h..iQJi. is rapidly metabolized by plants and by animals and, 
as a consequence, has not been found to accumulate to any 
serious extent in biota. 
Despite a moderate bioaccumulation potential in aquatic 
organisms, parathion and parathion-methyl are removed by 50 % 
from the biota in a few days and eliminated totally in a few 
weeks. 
6.2.4 Advice of the Scientific Advisory Committee 
Advice on the following substances will be available in 
March 1990. 
- Azinphos-ethyl 
- Azinphos-methyl 
- Dichlorvos 
-V 
28 
Advice on the following substances were delivered by the 
Committee and confirm the decision to include these substances 
in List I : 
Fenitrothion 
F e n t h i o n 
Malathion 
Parathion and 
Parathion-methyl (Réf. CSTE/87/67/C0M) 
(Réf. CSTE/87/65/C0M) 
(Réf. CSTE/87/103/C0M) 
(Réf. CSTE/87/69/C0M) 
CONCLUSION 
Based on the proposal of the Parliament: and on the result of 
the Ministerial Seminar, the Commission proposes an amendment 
to Directive 76/464/EEC according to Article 130S of the EEC 
Treaty. 
This amendment intends that Article 12 of Directive 76/464/EEC 
will be amended to enable the Council to take decision acting 
by qualified majority with regard to the determination of limit 
values and quality objectives pursuant to Article 6 of 
Directive 76/464/EEC for the substances included in the family 
and group of substances within List I of the Annex to Directive 
76/464/EEC. 
The Commission suggests that the procedure under Article 130S, 
second indent, of the EEC Treaty, shall first be applicable to 
the sixteen substances mentioned in this Explanatory Memorandum 
(point II) and Article 2 of the proposed modification. 
Any future selection of substances from List I of Directive 
76/464/EEC for the purpose of fixing limit values and quality 
objectives will be adopted by the Council acting unanimously 
and the determination of limit values and quality objectives 
for these substances will be adopted by the Council by 
qualified majority. 
A 
R EFERENCES 
"Study on the discharges of certain dangerous substances 
into the aquatic environment and the best technical means 
for the reduction of waterpollution from such discharges in 
application of the Directive 76/464/EEC (substances N° 44, 
52, 63, 88, 104, 106, 124)n - EXCOSER S.C. - September 1986 
- XI/686/86. 
"Assessment of the impact of the emission of certain 
halogenated organic compounds : Chloral hydrate, Cyanuric 
chloride, Hexachloroethane, Simazine, 1,1,2-Trichloro-
1 ,2,2-Trifluoroethane and Trifluralin on the aquatic 
environment" - Dr. L.K. Shuker and Dr. M. Hutton - European 
Science Foundation - September 1986 - XI/896/87. 
"Détermination de la réduction de 1'hexachlorobutadiène, de 
1'endosulfan, du pentachlorophénol et du trichlorophénol 
contenus dans les effluents en tenant compte des meilleurs 
moyens techniques disponibles" - Nucléaire s.à.r.l. - J.P. 
Focquet, R. Theisen - Juin 1981 - XI/83/87. 
"Evaluation de l'impact de 1'hexachlorobutadiène, de 
1'endo-sulfan, du pentachlorophénol, des trichlorophénols 
sur l'environnement aquatique" - Université Louis Pasteur 
de Strasbourg - G. Ourisson, P. Koch - Novembre 1980 -
XI/205/82. 
"Evaluation of the impact of Organotin compounds on the 
aquatic environment" -Netherlands Organization for Applied 
Scientific Research - TNO - Dr. H.A. Meinemo, Mrs. T.G. van 
Dam-Meerbeek, Dr. J.W. Vonk - 31 October 1986 - XI/539/87. 
"Tributyltin in the Environment - sources, fate and 
determination" - Uater Pollution Research Report 
Commission of the EEC, EUR 11562, 1988. 
"Evaluation of the impact of Parathion, Methyl-parathion, 
Fenitrothion and Fenthion on the aquatic environment" 
University of Ghent - G. Persoone, P. Vanhaeke, E. Gobbers 
- October 1985 - XI/171/86. 
"Evaluation of the 
environment" - Joint 
1983 - XI/44/84. impact of Malathion on the aquatic 
Research Centre ISPRA - G. Premazzi -
"The Pesticide manual" - Ch. R. Worthing, 
Editor, Glasshouse Crops Research Institute, Sixth Edition 
1979. 
3c 
10. "Pesticide residues in food 
jointly FAO and WHO, Report 1984. 1984", Report sponsored 
11. "Trifluralin -assessment of its Toxicity and Danger to 
Human Health, Paivi Julkunen and Olavi Pelkonen, Helsinki 
1986. 
l< 
Proposal for a 
COUNCIL DIRECTIVE 
amending Directive 76/464/EEC on pollution caused by 
certain dangerous substances discharged into the 
aquatic environment of the Community 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European Economic 
Community, and in particular Article 130s thereof. 
Having regard to Council Directive 76/464/EEC of 4 May 1976 
on pollution caused by certain dangerous substances discharged 
into the aquatic environment of the Community (1), and in 
particular Articles 6 and 12 thereof , 
Having regard to the proposal from the Commission (2), 
Having regard to the opinion of the European Parliament (3), 
Having regard to the opinion of the Economic and Social 
Comcuittee ( 4) , 
Whereas, in order to protect the aquatic environment of the 
Community against pollution caused by certain dangerous 
substances, Article 3 of Directive 76/464/EEC introduces a 
system of prior authorization laying down emission standards 
for discharges of the substances in List I in the Annex 
thereto; whereas Article 6 of the said Directive provides 
for laying down limit values for such emission standards 
and quality objectives for the aquatic environment affected by 
discharges of these substances; 
(1) OJ No L 129, 18.5.1976, p. 23. 
(2) 
(3) 
(4) 
Whereas pollution through discharges of the various 
dangerous substances within List I must be eliminated; whereas 
the Council should, within specific time limits and on a 
proposal from the Commission, adopt limit values which the 
emission standards should not exceed, methods of measurement, 
and the time limits with which existing dischargers should 
comply; 
Whereas Member States should apply these limit values, except 
where a Member State can prove to the Commission, in accordance 
wirh •> monitoring procedure set up by the Council, that the 
quality objectives established by the Council, on a proposal 
from the Commission, are being met and continuously maintained 
throughout the area which might be affected by the discharges 
because of the action taken, among others, by that Member 
State ; 
Unzreas, to enable Member States to demonstrate that the 
quality objectives are being met, provision should be made for 
reports to the Commission for each quality objective chosen and 
applled ; 
Whereas Member States should seek to ensure that the measures 
taken pursuant to this Directive do not have the effect of 
increasing soil or air pollution; 
Whereas substances and groups of substances are listed in List 
I in the Annex to Directive 76/464/EEC because of their persistence, 
toxicity and bioaccumulation; 
Whereas it is necessary to make the procedure establishing 
limit values and quality objectives for dangerous substances 
more efficient in order to achieve quickly common Community-
wide standards for those substances belonging to List I in the Annex to 
Directive 76/464/EEC; whereas the setting of limit values and 
quality objectives should, for reasons of time and efficiency, 
be carried out by the Council acting by qualified majority 
pursuant to the second paragraph of Article 130s; 
Whereas trifluralin, endosulfan, simazine, triorganotin 
compounds (i.e. tributyltin oxide, triphenyltin acetate, 
triphenyltin chloride, triphenyltin hydroxide), atrazine and 
Organophosphoros substances (i.e. azinphos- ethyl, azinphos-
methyi, fenitrothion, fenthion, malathion, parathion and 
parathion-methyl, dichlorvos) have been chosen mainly on the 
basis of the criteria adopted in Directive 76/464/EEC; 
Whereas, since pollution due to the discharge of these 
substances into the aquatic environment is caused by a large 
number of industries, it is necessary to lay down specific 
limit values for discharges according to the type of industry 
concerned and to lay down quality objectives for the aquatic 
environment into which these substances are discharged, 
HAS ADOPTED THIS DIRECTIVE : 
Axli.c_Ifi._L 
The first subparagraph of Article 12(1) of Directive 76/464/EEC is 
hereby replaced by the following: 
"The Council acting by qualified majority and after consulting 
the European Parliament and the Economic and Social Committee 
shall, within nine months, take a decision on any Commission 
proposal made pursuant to Article 6 and on the proposals 
concerning the methods of measurement applicable." 
AX_LlÊ.lfi.._2„ 
The following substances belonging to List I of the Annex to 
Directive 76/464/EEC will be considered on a priority basis for 
the purpose of fixing limit values and quality objectives : 
Trifluralin 
Endosulfan 
Simazine 
Triorganotin compounds : 
* Tributyltin oxide 
* Triphenyltin acetate 
* Triphenyltin oxide 
* Triphenyltin hydroxide 
Atrazine 
Organophosphoros substances : 
* Azinphos-ethyl 
* Azinphos-methyl 
* Fenitrothion 
* Fenthion 
* Malathion 
* Parathion and Parathion-methyl 
* Dichlorvos 
Article 3 
1. Member States shall bring into force the measures necessary 
to comply with this Directive by 31 December 1991. 
They shall forthwith inform the Commission thereof. 
The provisions adopted pursuant to the first subparagraph shall 
make express reference to this Directive. 
2. Member States shall communicate to the Commission 
the text of the provis-hons of national law which they adopt in the field 
governed by this Directive. 
The Commission shall inform the Member States accordingly. 
35 
ArtjçJ,e__l 
This Directive is addressed to the Member States 
Done at For the Council 


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