3. 4. 86 Official Journal of the European Communities No C 75/1 
II 
(Preparatory Acts) 
ECONOMIC AND SOCIAL COMMITTEE 
Opinion on the proposal for a Council Directive concerning the examination of animals and 
fresh meat for the presence of residues (!) 
(86/C 75/01) 
On 28 May 1985 the Council decided to consult the Economic and Social Committee, 
under Article 198 of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The Section for Protection of the Environment, Public Health and Consumer Affairs, which 
was responsible for preparing the Committee's work on the subject, adopted its opinion on 
7 January 1986, in the light of the Report by Mr Storie-Pugh. 
At its 233rd plenary session (meeting of 29 January 1986) the Economic and Social Committee 
unanimously adopted the following opinion: 
1. General comments 
1.1. The initiative of the Commission is welcomed, 
but major modifications to the proposal are required, 
and are referred to in this opinion. 
1.2. The proposal is based on the Directive 83/90/ 
EEC amending the fresh meat Directive 64/433/EEC 
and on a parallel Directive 81/602/EEC which prohibits 
stilbenes and thyrostatics and also on the Directive 85/ 
.../EEC prohibiting oestradiol 17E, progesterone, testos­
terone, zeranol and trembalone. These Directives 
require that a system of monitoring and control of 
residues be established. 
1.3. The purpose of this proposal is to establish 
sampling guidelines and an administrative framework 
to monitor the presence of residues of an extensive 
range of chemicals which might occur in animals and 
fresh meat. 
1.3.1. These substances basically fall into three 
groups: 
(a) substances the use of which is totally prohibited; 
(') OJ No C 138, 31. 5. 1985, p. 5. (b) substances the existence of which above a certain 
(tolerance) level is forbidden for human consump­
tion; 
(c) undesirable contaminants. 
1.4. The Committee recognizes the need for common 
measures to protect the consumer from such residues 
as they might represent a human health hazard. The 
Committee additionally supports the objective of 
removing barriers to intra-Community trade which 
result from the differing veterinary and public health 
requirements of the Member States. 
1.5. In general, Commission document COM(85) 
192 final proposes that a system of sampling and analy­
sis be instituted and administered primarily by the 
Member States, with Community laboratories to liaise 
with national reference laboratories. Each Member 
State would be responsible, both administratively and 
fiscally, for its own system. 
1.6. The present proposal addresses itself exclusively 
to those residue control measures involving the examin­
ation of animals and fresh meat for existing residues. 
The Committee feels that it is important not to neglect 
the need for other kinds of measures to prevent the 
occurrence of harmful residues. That is, one achieves 
the most complete protection of the consumer by ensur­
ing that approved veterinary drugs and other approved 
No C 75/2 Official Journal of the European Communities 3. 4. 86 
chemicals are used correctly, avoiding practices which 
result in unacceptable levels of residues. This ''upstream' 
aspect of residue control is best addressed through 
efforts to educate those who administer chemicals to 
animals, so that they are made aware of the possible 
consequences of agricultural practices on public health. 
A significant portion of the responsibility for education 
in the proper use of veterinary and agricultural chemi­
cals falls upon the manufacturers and distributors of 
those products. The role of the practising veterinary 
surgeon in the distribution and use of animal health 
products is critical for ensuring that veterinary medical, 
animal protection and public health aspects are all 
taken into account when medecines are made available 
to farmers, and their staff. 
1.7. In a preventive approach two other factors can 
play some part: 
(a) a greater emphasis on antemortem inspection e.g. 
for injection sites, or suspicion of recent therapy; 
(b) a greater practical awareness of environmental pol­
lution problems as a possible hazard, of a chronic 
nature, to livestock. 
1.8. The practical effect of limiting the advertising 
of prescription only medicines should be looked into. 
Indeed the POM category could be considerably 
expanded if the public is to be satisfied that those with 
the appropriate training are handling and advising on 
all aspects of the correct use of medicines in animals. 
2. Sampling 
2.1. The philosophy of a basic monitoring regime 
with more intensive checking if problems are found, is 
the right one. However, because the concern to protect 
the consumer is paramount, it is necessary to use the 
resources available for residue control in the most effec­
tive way possible. 
2.2. While sampling of urine, faeces, blood or milk 
from live animals on the farm is an effective means of 
monitoring for prohibited substances and environmen­
tal contaminants, it is not always adequate at present 
for the quantitative determination of illegal levels of 
approved substances. For some of the latter, carcase 
sampling of edible tissues, including offal, is indispens­
able. The quantitative determination of residues of approved 
substances in the live animal should become more useful 
as quantitative analytical methods are improved. 
3. Assays, tolerances and laboratories 
3.1. It should be noted that the consumer's interests 
would be best served where possible if two official 
analytical methods were available for each substance: 
(a) A rapid, inexpensive screening method designed to 
detect very low levels of prohibited substances and/ 
or levels of approved substances near or exceeding 
the tolerance levels to be established for those sub­
stances. Such methods would be employed for resi­
due monitoring in the approved Member State lab­
oratories; 
(b) A specific method (almost inevitably more laborious 
and expensive to run) for official confirmation of 
any positive results obtained with the screening 
method. The confirmatory procedures would be 
carried out by an approved reference laboratory for 
the substance in question; 
(c) One screening test and one reference test should be 
agreed for each substance; 
(d) More study is required of the possible toxicity and 
relevant analytical methods for 'cocktails' i.e. mix­
tures of administrable substances; 
(e) Target organs for testing must be laid down. 
3.2. If the livestock industry is to have confidence 
there must be provision made by Member States for re­
examination and independent expert opinion. Retesting 
must not be carried out at the same laboratory as 
performed the original test. 
4. International trade 
4.1. Whereas more favourable conditions for trade 
to the Community cannot be given to third countries 
than to Member States, it can be pointed out that 
many countries already have to meet with similar third 
country requirements in regard to substances having a 
residue potential. There should be the usual degree of 
liaison in these matters with third countries, so as 
to facilitate compliance with these proposals and to 
minimize unnecessary disruption of international trade. 
Encouragement should be given to accelerate current 
initiatives to get international standards agreed for 
minimum residue levels. Indeed, a universally accept­
able system of residue control seems long overdue. 
3. 4. 86 Official Journal of the 
5. Residue-positive carcase disposal 
5.1. A much clearer explanation must be given of 
the criteria for disposal or utilization of carcases and 
offals, removed from the human food chain. 
5.2. This lack of clarity is made worse by the con­
flicting statements in Article 6 of 85/358/EEC, and the 
risk therefore exists that pet food manufacturers could 
inadvertently receive batches of material which should 
not be placed on the market for animal consumption. 
53. It is necessary to include a requirement that 
meat and offal excluded from the human' food chain 
under these proposals should be destroyed in such a 
way that they do not become available for pet food 
either as fresh meat or in rendered products such as 
meat meal. 
5.4. As a separate point, it is not clear as to where 
detained carcases are to be held pending a final decision. 
Certainly detention space in abattoirs is limited. 
6. Animal identification 
6.1. It is a truism that no control system, no tracing 
mechanism, can be effective without proper identifi­
cation of animals. Careful consideration must be given 
to the most effective (and cost-effective) means of 
achieving this, preferably on an agreed Community 
basis. 
7. Excluded food species 
7.1. A clearer statement of intention should be given 
as to control in animal species not covered by these 
proposals such as poultry and game, and in fish (for 
which more research/information is needed). 
8. Priority criteria for implementation 
8.1. The Committee, aware both that certain impor­
tant points are understandably glossed over in the Com­
mission's proposal, and that the Committee will not be 
consulted when practical details are formulated, draws 
attention to certain points of view. 
8.2. Consumers can feel confident that this proposal 
is meaningful-i.e. will lead to a reduced risk of en-
dangerment to health — if, and only if— European Communities No C 75/3 
(a) a clear position is taken as to what extraneous 
substances are forbidden and what are permitted. 
If long-term consumer interests are to be protected 
(in this as in other fields), such lists must be based 
on incontestable factual evidence. One can hardly 
advance without this basis. 
(b) analytical methods are of such a nature (adequate 
sensitivity and precision, capacity to be widely 
applied with good reproducibility, low rate of false 
positives or false negatives) that consumers are not 
lulled into a false sense of security. Additionally, the 
designation of official assay methods for approved 
substances logically must follow the establishment 
of the corresponding tolerance levels (maximum 
residue limits). 
(c) tolerance levels (harmless residue levels remaining 
on expiry of the delay period) and the corresponding 
delay periods are harmonized throughout the Com­
munity for individual pharmaceutical products. 
This is essential for the uniform interpretation of 
residue test results. These tolerance levels and delay 
periods should be established by the Committee 
for Veterinary Medicinal Products (CVMP) set up 
under the veterinary medicines Directives. This 
work should be accelerated, as it is an unfortunate 
fact that no tolerance levels have yet been estab­
lished for any of the substances listed in the Annex 
to this proposal—with the exception of the zero 
tolerance of the prohibited stilbenes and thyrostat-
ics. A list of 'residue limits' is already used in the 
USA 1985 National Residue Testing Programme. 
(d) more attention is focussed upon mechanisms 
already in place when new products are licensed for 
controlling residues before a given chemical ever 
gets into an animal. By setting an appropriate toler­
ance level for the chemical in question and approv­
ing only formulations which are known not to result 
in residues in excess of the tolerance level, the 
licensing authorities can diminish the practical 
problem of residues of that compound from the 
outset. 
9. Specific comments 
Article 2 
(a) 'Approved sample' means a sample taken at random 
by the competent authority for the examination of a 
given residue and which is clearly labelled with a refer­
ence to the species; the tissue and the amount, the 
method of collection, packaging and despatch; the 
identification of origin and the date of collection. 
No C 75/4 Official Journal of the European Communities 3. 4. 86 
(b) The criteria for the designation of official labora­
tories for each substance at the regional, national and 
Community levels is left as the subject of a future 
proposal. The ESC recommends that not only govern­
ment laboratories, but all competent independently 
supervised laboratories be eligible to be certified as 
'approved laboratories' for residue analysis. 
(c) A more accurate definition of residue should be 
arrived at. The present definition of residue taken from 
the fresh meat Directive can be taken to imply that 
what remains as a result of substances having a pharma­
cological action are likely to be dangerous to human 
health. As a general statement this is incorrect and, 
unless they are taken in large quantities, is not true of 
some of the particular substances listed in the Annex. 
Article 3 
1. (a) A reference to providing a sufficient sample to 
allow confirmatory assays must be included. 
1. (b) The 'comparative tests' should include compari­
sons between different methods in the same laboratory 
and comparisons of the same test performed at different 
laboratories. 
Article 4 
3. (a) Add the word 'counted' before the word 'pro­
vided' in line 3. 
3. (c) It will be extremely difficult to detect substances 
above the maximum permitted levels on farms where 
the withdrawal periods have not been met. In such 
situations the farmer would clearly say that no offence 
had been committed and that he intended to comply 
with the conditions of use of that particular product. 
One could also argue that it is far more important to 
ensure that the minimum residue level is not exceeded 
than that the withdrawal period is met. 
3. (d) This is too restrictive and there is no reason why 
an animal should not be disposed of subject to licensing 
and specific conditions applicable thereto. 
4. first subparagraph: The requirement for one week's 
notice of the proposed slaughter of animals the slaugh­
ter of which is prohibited, is unrealistic in relation to 
casualty stock for which humane considerations dictate 
immediate slaughter. 
4. second subparagraph: Where are these carcases to be 
detained? At whose cost? The slaughterhouse cannot 
be expected to provide the space or pay the bill. Article 6 
1. Add '(or to a greater extent if required by the Mem­
ber State)' after 'in accordance with the Annex'. 
Annexes 
1. The Committee restricts itself to some general 
comments, but would be misleading if it did not express 
considerable reservation about the proposed classifi­
cation and methodology. 
2. The Committee reaffirms one of its main premises 
for the protection of the consumer. The difficulties and 
errors frequently noted in the analysis of chemicals in 
biological material underlines the need to ensure the 
correct use of such substances and the need to stop, as 
far as is practicable, substances which are, or whose 
metabolites are, potentially hazardous to human health 
from getting unnecessarily into the animal in the first 
place. 
3. The Annex is in need of rethinking and revision, 
and a greater clarity of aim and expression would give 
more confidence in the scheme's workability (e.g. the 
meaning of 'positive findings' varies: the' meaning of 
some paragraphs is totally obscure—-see page 8 'Sup­
plementary Survey' (a) and (b)). The Commission pro­
posal requires considerable modification and refine­
ment. Otherwise a very expensive sampling and moni­
toring system will be established without due regard to 
the residues it is intended to detect. 
In support of this contention attention can be drawn 
to some exemplary views. 
3.1. In general it can be argued that the sampling 
systems are too inflexible and do not take full account 
of population size, drug authorization, drug usage and 
previous results (e.g. in Chapter II paragraph 5 one 
might add 'unless such testing has already been done 
to this extent in previous years'). The variable criteria 
(Chapter I 3b) are difficult to gauge as a first stage. 
What is needed is a State base line, so that far more 
discretion should be left to Member States to allow 
them to determine what tests should be conducted. 
3.2. It should be made clear that sampling fre­
quencies refer only to random sampling for survey 
purposes—not for suspect investigations. This in effect 
probably restricts this sampling to abattoirs. 
3. 4. 86 Official Journal of the European Communities No C 75/5 
3.3. There is questionable validity of the Com­
mission's apparent assumption that prohibited com­
pounds require highly frequent sampling; nevertheless, 
noting the Commission's recent proposals regarding 
Group II substances making them prohibited sub­
stances, should not the testing level be changed, as for 
substances in Group I, to reflect their new-found danger 
to public health. 
3.4. One wonders what is the scientific justification 
for subjecting pesticides to less rigorous requirements 
than that proposed for anabolics and antibiotics given 
the known toxicity of the organophosphorous com­
pounds, their persistence and the fact that there is 
frequently inadequate supervision. 
3.5. It might be wiser, or at least of interest, to know 
which substances are to be tested for and then tailor 
the categories accordingly. It is difficult to grasp the 
logic of the proposed classification, which seems to be partly by similarity of function, partly by similarity 
of legal status and partly by similarity of analytical 
methodology. 
A more pragmatic system might be devised based on 
four categories of priorities for the assay of the whole 
range of compounds. Priorities might thus be allocated 
on the basis of: 
(a) importance to the consumer; 
(b) practicality of tests available; 
(c) amount used and conditions of use; 
(d) potential for misuse. 
3.6. Care should be exercised in not making the 
list of substances too specific and too comprehensive. 
Room must be left for flexibility, to allow for both 
additions and deletions. Since when, for instance, has 
arsenic been a heavy metal (Chapter 1.1 Group V) ? 
One seriously doubts whether there is any rationale for 
listing some of the others in that group at all. 
Done at Brussels, 29 January 1986. 
The Chairman 
of the Economic and Social Committee 
Gerd MUHR 
Opinion on the proposal for a Council Directive on a general system for the recognition of 
higher education diplomas (*) 
(86/C 75/02) 
On 26 July 1985 the Council decided to consult the Economic and Social Committee 
under Article 100 of the Treaty establishing the European Economic Community on the 
abovementioned proposal. 
The Section for Industry, Commerce, Crafts and Services, which was responsible for preparing 
the Committee's work on the subject, adopted its opinion on 8 January 1986, in the light of 
the report by Mr De Bievre. 
At its 233rd plenary session (meeting of 29 January 1986) the Economic and Social Committee 
adopted the following opinion by 55 votes to 3, with 6 abstentions (vote recorded). 
The Committee approves the proposal for a Directive, subject to the following general and 
specific comments: 
1. General comments 
1.1. The Committee notes that little headway has 
been made so far on the right of establishment and the 
OJ No C 217, 28. 8. 1985, p. 3. freedom to provide services, largely because of the 
complexity of the task of harmonizing occupational 
qualifications; this situation is very disadvantageous for 
persons who have obtained higher education diplomas 
or professional qualifications in their country of origin 
but are unable to use them in other Member States.