18. 8. 86 Official Journal of the European Communities No C 207/3 
1. The Committee agrees to the proposed Directive 
providing for supplies of services relating to the future 
cross-Channel fixed link to be exempted from VAT, with 
the right of refund of the tax paid on such services at the 
preceding stage. 
2. The Commission's proposal is simple, logical and fair 
since all cross-Channel communications are placed on an 
equal footing. This decision would have to be reviewed, 
Done at Brussels, 21 May 1986. 
1. The Committee: 
— strongly supports the concept of these proposals and 
agrees with most of the provisions, 
— differs in certain aspects, 
— recommends a number of modifications. 
In general, the Committee has tried to avoid going into too 
much detail in its comments, being of the view that the 
Commission's proposal should act as a framework for a 
sentient approach, allowing national authorities to 
elaborate, from the proposal's base line, the system which 
best suits their circumstances. 
2. General comments 
2.1. The European Convention (adopted on 31 May 
1985 by the 21 Member States of the Council of Europe) has 
two objectives: 
(a) to reduce the number of animals used for experimental 
purposes; 
(!) OJ No C 351, 31. 12. 1985, p. 16. should VAT be imposed on other cross-Channel transport 
services for purposes of ruling out any distortion of 
competition. 
3. The Committee grasps this opportunity to urge the 
Commission to speed up work so as to end the dis­
crepancies still to be found in respect of indirect taxation on 
passenger services in general. 
The Chairman 
of the Economic and Social Committee 
Gerd MUHR 
(b) to safeguard the welfare of animals used in experiments 
so as to avoid all unnecessary suffering. 
2.2. The present proposal seeks to embody within the 
framework of Community rules the principles, objectives 
and main elements which are to be found in the European 
Convention. The intention of the present proposal is to 
ensure the full implementation of the Convention on a 
consistent and coherent basis in the Member States. The 
Committee recommends that the final text of the proposal 
be as close as possible to the text of the Convention for ease 
of interpretation generally. 
2.3. The European Convention on ratification will be a 
valuable step forward in laboratory animal welfare. It took 
several years of careful discussion by the participating 
countries to develop the framework of the Convention and 
associated guidance. Encouragement should be given to 
those countries which are not Member States of the 
European Community to ratify and implement the 
provisions fully. 
2.4. The present proposals are warmly welcomed and 
supported in their general endeavour. The aims of the 
proposed Directive are entirely supported. Whilst it is Opinion on the proposal for a Council Directive on the protection of animals used for 
experimental and other scientific purposes (}) 
(86/C 207/03) 
On 20 January 1986 the Council decided to consult the Economic and Social Committee, under 
Articles 43 and 100 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 6 May 1986 
in the light of the report by Mr Storie-Pugh. 
At its 237th plenary session (meeting of 21 May 1986) the Economic and Social Committee 
unanimously adopted the following opinion. 
No C 207/4 Official Journal of the European Communities 18. 8. 86 
important that all Member States achieve a uniform high 
standard of provision for the welfare of laboratory animals, 
controls to ensure laboratory animal welfare must be based 
on the framework which has been fully discussed and 
agreed within the Council of Europe. 
2.5. It is important that the provisions of the Conven­
tion can be implemented in Member States so as to bring 
laboratory animal protection to a uniform standard 
throughout the Community. The Committee stresses that 
there is no impediment to Member States adopting more 
advanced national legislation. 
2.6. The long-term aim should be to upgrade laboratory 
animal protection to the highest standards already existing. 
2.7. Great benefits in science, human and animal 
medicine and in public health have flowed from animal 
experiments in the past and will continue to flow. Research 
on laboratory animals is essential in the discovery and 
development of new medicines, the production and safety 
testing of vaccines, the assessment of safety of pesticides, 
industrial chemicals and other products, and in protection 
of human and animal health and the environment. Controls 
proposed to protect laboratory animals must maintain the 
balance between their welfare and the legitime needs of 
science and industry. 
2.8. Animal experimentation is an activity with moral 
content. Use of animals needs to be stringently justified. 
Hence a balance must be struck between the interests of 
science, industry, public health and animal health in terms 
of animal use. Animals so used must be protected from all 
avoidable suffering. Therefore the aim of this Directive is to 
reduce unnecessary animal use and suffering to the 
minimum. Note, however, that reduction in animal 
numbers must always be subordinate to suffering in 
individual animals. 
As a general principle, licensing authorities must ensure 
that the object to be attained by any procedure is equated 
with the possible degree of suffering likely to be entailed by 
that procedure. 
2.9. There are at present few validated in vitro 
alternatives to the use of laboratory animals, although 
many techniques are used to complement and refine 
methods and thus reduce the number of animals used and 
help to minimize pain and distress. European Community 
research programmes should be directed towards the 
development of such techniques. 
2.10. Refinement implies a progressive improvement in 
experimental design, methodology and technique. The 
Committee stresses this need to refine techniques (includ­
ing, when appropriate and without frustrating the object of 
the intervention, the use of appropriate analgesics, not 
forgetting in rodent species) and to develop less distressing 
end points in toxicity and vaccine-potency tests. Harmoniz­ation of test methods and guidelines requiring the use of 
animals should be given a priority, particularly in the case 
of standards for control of vaccines. 
2.11. The Commission, in preparing this proposal, 
states that it has been inspired by certain main principles, 
one of which is that 'lower-order animals should be used as 
appropriate with the aim of the experiment7. The 
Committee agrees with this principle and furthermore 
affirms that in cases where in vitro experiments are not 
possible, the expected gain in knowledge from the planned 
animal experiments must justify recourse to the proposed 
species of animal. Thus the requirements for gain in 
knowledge should become stricter according to the 
'ranking' of the species concerned (the 'ladder' principle). 
Authorization should only be granted if the desired results 
are of particular importance and cannot be ascertained 
from a 'lower species'. The Committee is in agreement with 
Article 7 of the Convention which states: 
'When a procedure has to be performed, the choice of 
species shall be carefully considered, and where required, 
be explained to the responsible authority'. 
There are clearly special concerns for the husbandry of 
certain species under laboratory conditions — for example 
non-human primates, and these should be given close 
consideration under Annex II (already given under 
Appendix A of the Convention). 
2.12. The Commission as a matter of urgency must use 
its influence to review the current standards demanded for 
testing, standards and so forth and try to induce a sense of 
urgency in the regulatory bodies concerned. It should 
review existing Community Directives with a view to 
reducing requirements for animal testing, and use its best 
influence to achieve modifications in various international 
for a. 
2.13. The method of enforcement of this Directive will 
be essential to achieving its aims. 
Member States should adopt a framework for implemen­
tation of controls over the use of laboratory animals which 
ensures that the provisions are properly enforced — for 
example by a suitable qualified national inspectorate, or 
other methods (such as animal 'care and use' committees or 
regional ethical committees) depending on the constitution 
of the national competent authority. 
2.14. There is provision (Article 17) for pooling 
information and expertise from Member States and 
achieving good coordination. This should help generally. 
It is not appropriate, however, for such a committee to 
intervene in the activities of national, public or private 
research institutions, nor in national research policy, as this 
18. 8. 86 Official Journal of the European Communities No C 207/5 
role must remain with the national competent authority as 
the latter sees fit. 
Notwithstanding, it is the duty of the Commission to 
organize the appropriate exchange of information and 
expertise in the context of the implementation of this 
Directive, and seek to ensure higher standards. 
2.15. The Committee calls upon the Commission to 
ensure that the provisions of this proposal do not adversely 
affect the Community's industrial position and advance­
ment. In its simplest terms it would not be in the interests of 
animals, were research, development, production and 
testing to be diverted to countries outside the Community, 
where different and possibly less stringent standards might 
prevail (in other words, there is a dual duty, one of which is 
to watch the interests of animals which may be outside the 
jurisdiction of the Community proposals). See Article 33 of 
the Convention. 'The Committee of Ministers of the 
Council of Europe may invite any State not a member of the 
Council to accede to this Convention.' 
2.16. The Committee specifically draws attention: 
— to certain areas in which its thinking and conclusions 
differ from those in the proposal: 
— there should be non-discrimination of species, 
— experiments in schools should be prohibited, 
— the notification procedure should be brought into 
line with the real-life situation; 
— to certain areas (in which avoidable suffering can 
frequently be reduced) in which an increased emphasis 
would be welcomed: 
— strongly encourage training at all levels, and 
continuing education courses, 
— more study should be undertaken into husbandry 
requirements; 
— to certain areas where immediate action should be 
taken: 
— current legislation, including Directives, to see 
whether reasonable modifications are possible to 
achieve an acceptable, sensible standard and balance 
between consumer demands for protection and the 
related number of animals and possible distress 
which may ensue in such testing. Some legislation in 
draft seems out of touch with current thinking (e.g. 
in regard to pet-food testing), 
— harmonization of international standards and 
testing regulations, 
— the trading position of third countries; 
— to certain areas where discussion between the national 
authorities of the Member States seems desirable: — national authorization procedures, 
— national inspectorates (or equivalent), 
— personal licensing, 
— statistics/data banks/confidentiality, 
in the expectation that this proposal can be made truly 
meaningful without unnecessary bureaucracy. 
3. Specific comments 
3.1. Article 1 
3.1.1. Article 1 (1) 
It is presumed that it is the Commission's intention that the 
definition of an experiment conforms with that contained 
in the Convention Article 1.2 (c) for a 'procedure' (some 
scientific procedures are not 'experimental', such as 
vaccine-potency testing or production of sera). The two are 
not the same. 
3.2. Article 2 
A definition of foetus (eggs) is required (not in Conven­
tion), and clarification in the various languages of the 
meaning of 'feral'. 
In general, a closer linguistic conformity with the 
definitions of the the Convention would seem essential. 
3.2.1. Article 2 (1) (a) 
The Committee supports inclusion of Cephalopoda 
(although uncertain whether this proposal is the ap­
propriate place), believing there is enough indication of 
their susceptibility to pain to give them the benefit of the 
doubt. Octopuses are used substantially by neurologists in 
some countries and some of the experiments are severe. The 
Committee would not wish to extend protection to other 
invertebrates at this stage— it would be too confusing and 
complicated. 
3.2.2. Article 1 (1) (d) 
Although humane methods of killing and marking are 
excluded, accepted veterinary practice is not excluded. This 
is one of several instances where provisions appear to have 
been lifted from the European Convention without careful 
consideration of the context in which they are placed. A 
specific exclusion should be included for veterinary 
practice, for clinical trials of veterinary medicines and for 
certain specific agricultural practices such as castration and 
No C 207/6 Official Journal of the European Communities 18. 8. 86 
disbudding. (Some aspects are already covered by other 
Community legislation, e.g. clinical trials). 
3.3. Article 3 
3.3.1. Define 'endangered species' as under Washington 
Convention, Appendix 1. 
3.3.2. The use of endangered species should be permit­
ted only under special circumstances approved by a 
national competent authority and must be rigorously 
justified. It is appreciated that exceptionally a particular 
species proves to be the only one suitable for essential 
medical or other scientific research (and, indeed, in practice 
this very quality may be an incentive to try and breed such a 
species in captivity). 
Basically, however, the two major criteria for the use of an 
endangered species are: 
(a) to conduct research to preserve that species; 
(b) when the species can be purpose-bred successfully in 
captivity. 
3.4. Article 4 
3.4.1. Article 4 (1) 
This should be an important Article (equivalent to Article 5 
and Appendix A of the Convention). The welfare of 
laboratory animals cannot be ensured without adequate 
attention to husbandry. Good husbandry should meet the 
ethological needs of the species in question balanced 
against procedures. 
The Committee believes that Annex II of the Directive 
should consist of the full text of Appendix A of the 
Convention Guidelines for the accommodation and care of 
animals. 
3.5. Article 5 
3.5.1. Article 5 (1) 
Hopefully this means that national responsible authorities 
will be expected to establish an inspectorate system. The 
Committee supports the establishment of national inspec­
torates. 
3.5.2. Article 5 (2) 
It is not clear whether this implies a personal-licensing 
system. The Committee is firmly of the opinion that a 
personal licence is essential, implying that the licensee has 
the proper knowledge, skill and expertise to carry out 
certain defined procedures. Such a licence, by itself, is not a 
permit to carry out an experiment, but is a necessary 
complement to a project-approval system. 3.6. Article 6 
3.6.1. Article 6 (1) 
This is vague. Delete 'is reasonably and practically 
available'. It is a 'subjective' assessment whether an 
'alternative' exists for some research projects. In other 
cases, e.g. a particular toxicity or vaccine test, the question 
will be simple to answer. 
3.6.2. Article 6 (2) 
Replace 'where required, shall' with 'should be required 
to'. The case for using the species chosen should always be 
clearly stated, both on scientific and welfare grounds. The 
other provisions of this paragraph are sound. 
3.6.3. Article 6 (3) 
Rewrite the first sentence to read: 
'All experiments shall be designed to reduce pain, 
discomfort and distress to the minimum, using, when­
ever appropriate, general or local anaesthesia and post-
procedural analgesia.' 
3.6.4. Delete the last two sentences (and hence Annexes 
III, IV and V) and replace by the following three paragraphs 
as Article 6 (4), Article 6 (5) and Article 6 (6). 
Article 6 (4) 
'Where appropriate, experiments shall be performed under 
general or local anaesthesia, or by other methods designed 
effectively to eliminate as far as practicable pain, suffering, 
distress or lasting harm, applied throughout the procedure 
used. Anaesthesia is not appropriate where the methods are 
judged to be more distressing for the animal than the 
procedure itself, or is incompatible with the aim of the 
procedure. Such procedures shall be declared to the 
responsible authority, unless previously authorized.' 
Article 6 (5) 
'When an animal which is being or has been subjected to a 
procedure experiences severe pain which is likely to endure, 
it should be immediately killed by a humane method.' 
Article 6 (6) 
'1. At the end of any experiment it shall be decided whether 
the animal shall be kept alive or killed by a humane 
method, subject to the condition that it shall not be kept 
alive if, even thought it has been restored to normal health 
in all other respects, it is likely to remain in lasting pain or 
distress. 
18. 8. 86 Official Journal of the European Communities No C 207/7 
2. The decisions referred to in paragraph 1 of this Article 
shall be taken by a competent person, in particular a 
veterinarian, or the person who is responsible for, or has 
performed the procedure. 
3. Where at the end of an experiment: 
(a) an animal is to be kept alive, it shall receive the care 
appropriate to its state of health and be placed under the 
supervision of a veterinarian or other competent person 
and shall be kept under conditions laid down in Article 4 
and Annex II. The conditions laid down in this 
subparagraph may, however, be waived where, in the 
opinion of a veterinarian, the animal would not suffer as 
a consequence of such exemption. 
(b) an animal is not to be kept alive or cannot benefit from 
the provisions of Article 4 for its well-being, it shall be 
killed by a humane method as soon as possible. 
4. No animal which has been used in an experiment 
entailing severe or enduring pain or suffering, irrespective 
of whether an anaesthetic or an analgesic was employed, 
shall be used in a further procedure unless it has returned to 
good health and well-being, and either: 
(a) the further experiment is one in which the animal is 
subject throughout to general anaesthesia from which it 
is not allowed to recover, 
or 
(b) the further experiments will involve minor interventions 
only.' 
3.7. Article 7 
3.7.1. Appropriate training and requirement of requisite 
skills is very important. The training and calibre of 
handling personnel is an essential element in translating the 
spirit of the Commission proposal into reality, and in 
general is the responsibility of senior staff in universities 
and research institutes and of management in industry. 
Training in this situation refers to animal technicians, 
licensees and veterinarians. A number of Member States 
organize courses of a high standard for animal technicians, 
and the Commission should encourage Member States to 
exchange information with a view to a voluntary adoption 
of such a system by all countries. 
It is important, however, to get into perspective that it is not 
worth training users to be competent in all aspects. Any 
training that is required is best carried out on courses 
specifically aimed at the procedures that licensees are to 
carry out personally so that these limited procedures are 
carried out competently, efficiently and humanely. As to veterinarians, the Commission should invite the 
Advisory Committee on Veterinary Training, which is 
already examining postgraduate education, to review the 
position of laboratory animal science, for which specialist 
diplomas and courses already exist in some Member States, 
with a view to a wider adoption of this speciality. 
In all cases, continuing education and refresher courses 
should be established. 
3.8. Article 8 
3.8.1. Article 8 (1) 
Article 8 needs redrafting. It is impracticable to notify each 
individual experiment 30 days prior to its conduct. 
Allowance must be made for an open and flexible system of 
notification on a project basis. 
3.8.2. One wonders whether this provision would result 
in effective implementation. If only notification is required, 
an incompetent or negligent authority could sit back and do 
nothing. The fundamental question is whether or not this 
Article should be replaced by provision for proper licensing 
at the national level. Development and implementation of 
licensing systems could proceed with advice from the 
central advisory committee, and be monitored by this body. 
This would be difficult and would take time, but would 
seem, in the long term, the most effective means of attaining 
the objectives of the Directive. The Committee emphati­
cally supports a dual licensing system — personal and 
project. 
3.8.3. Article 8 (3) 
Replace 'the animal well-being aspects of good laboratory 
practice' with 'due consideration for animal welfare'. 
3.8.4. Article 8 (4) 
Delete. Vide supra paragraph 2.11. 
3.8.5. Article 8 (6) 
Why should these be exempted ? 
There could be conflict between this and Article 9 (1). What 
is necessary is a scientific re-examination of Community 
Directives with a view to harmonization and cutting out 
unnecessary duplication and unnecessarily severe end 
points. 
3.9. Article 9 
3.9.1. Although we accept the need to avoid unnecessary 
replication of experimentation, there are good scientific 
and commercial reasons why certain tests must be repeated. 
No C 207/8 Official Journal of the European Communities 18. 8. 86 
3.10. Article 10 
3.10.1. Article 10 (1) 
In the first sentence delete 'as far as possible'. The second 
sentence should read 'Whenever teaching purposes allow, 
visual and other suitable methods etc,'. It is recognized that 
such means, at higher education levels, are frequently not 
effective. 
3.10.2. Article 10 (2) 
Delete all after 'lower level'. There is no justification for use 
of living animals by schoolchildren. Those preparing for 
special careers might be authorized to use them at student 
level (define this level e.g. for truly professional courses). 
3.11. Article 11 
3.11.1. For certain experiments, e.g. those designed to 
detect adverse effects on the environment, it is necessary to 
use animals obtained from the wild. A total ban on the use 
of wild animals will prevent the use of such animals in these 
experiments. This provision would appear to conflict with 
Article 15 (3) which states that bred animals shall be used 
whenever possible but by implication not exclusively. A 
general exemption to permit certain procedures is neces­
sary. 
3.11.2. At the end of the first sentence add a provision 
that this need not apply to animals supplied by farms, zoos, 
or other establishments breeding animals for non-scientific 
uses. Provision should be made for some use of animals 
taken from the wild where this can be justified. 
3.11.3. Second sentence: The object is to eliminate the 
use of strays, feral and stolen animals and restrict use to 
purpose-bred animals (especially in the case of cats and 
dogs). Note however that feral animals may be needed to 
study problems related to feral animals, e.g. sterilization in 
feral-cat populations. This second sentence should be 
strengthened or a loophole might exist to frustrate the 
intention. Exemption needed: 
(a) to replace or renew or broaden genetic basis of breeding 
stock; 
(b) to study breed-related disorders. 3.12. Article 12 
Needs to be at a sufficiently high level of authority as well 
as competent. 
3.13. Article 13 
3.13.1. The detailed information to be collected from 
breeding and supplying establishments should not be 
published. 
3.14. Article 14 
3.14.1. Article 14 (3) 
What does this really mean? Is it weaned i.e. without its 
dam, or is it unweaned, i.e. with its dam. 
3.15. Article 15 
3.15.1. Article 15 (2) (a) 
Such a person would usually be a senior animal technician 
or curator. The authority for this person to take action to 
relieve suffering or terminate animals' lives if considered 
necessary is essential. However, the person should first be 
required to notify the person carrying out the experiment 
(who is the person actually responsible) if he/she is readily 
available. 
The experimenter must have ultimate responsibility. This 
does not prevent him/her delegating authority to the 
'competent person' to take necessary remedial action in his/ 
her absence. The 'competent person' is likely to be on the 
spot at all times whereas the experimenter may not be. 
The last part of the sentence is not clear. Whether an 
experiment is 'properly conducted' is not the point at issue. 
It may well be so, and yet still lead to avoidable, relievable 
or unexpected suffering. Also terminating an experiment is 
not the same as killing individual animals. Re-phrase, 
something like: 
'A competent person working full time in the establish­
ment who is responsible for the care of the animals and 
the functioning of the equipment used shall be identified. 
This person shall have the authority to inform the 
experimenter when action is needed to relieve suffering 
or kill animals where an unacceptable level of suffering 
has occurred which cannot be relieved. The person shall 
have authority to take such action on his/her own 
initiative where the experimenter is not readily avai­
lable.' 
18. 8. 86 Official Journal of the European Communities No C 207/9 
3.15.2. Article IS (2) (c) 
Vide supra paragraph 3.7.1. 
3.15.3.Article 15 (2) (d) 
This does not really cover the need for skilled surgeons and 
anaesthetists, etc. It should be drafted broadly to cover 
'competence in scientific procedures to be carried out'. 
3.15.4. Article 15 (4) 
Records should include the date of use of animals and their 
euthanasia so that a complete record is available from the 
time of an animal's acquisition to its death. Such records 
should be kept for three years. 
3.16. Article 16 
No comment. 3.18. Article 19 
3.18.1. Paragraph 1 is very welcome. However, there is 
concern about the scope of paragraph 2. The exchange of 
information on the requirements in the Member State will 
be of considerable use, but the exchange of factual 
information on experiments gives rise to concern about 
confidentiality and the use to which such information will 
be put. If the information is used to facilitate the placing on 
the market of a product by any party other than the party 
on whose behalf the experiment was carried out, this 
provision will significantly distort competition and would 
not be acceptable. 
3.19. Articles 20,21, 22 and 23 
No comment (though a transitional period of one year is 
too short a time to implement the changes proposed). 
3.17. Articles 17 and 18 
3.17.1. The central committee should not monitor the 
implementation of the Directive. It should pool inform­
ation and resources and make it available to Member States 
where needed. This committee's composition, authority, 
duties and responsibilities need to be clearly spelled out. We 
again draw attention to provisions for wild and farm 
animals and to breed-related disorders. 
3.17.2. The Annexes to the proposed Directive are of 
great significance. It must be made clear as to whether any 
additional consultation procedure is envisaged. Small 
changes in the Annexes could be of major significance to 
science and industry. 3.20. Annexes 
3.20.1. Annex I: Chickens might come from farms. 
Include all hamsters, not solely golden. 
3.20.2. Annex II: Vide supra paragraph 3.4.1. 
3.20.3. Annexes III and IV: Delete. Replace by Articles 
6 (4) and 6 (5). 
3.20.4. Annex V: Delete. Replace by Article 6 (6). 
3.20.5. Annex VI: The data to be collected for statistical 
information need to be more detailed than this, and should 
conform to that requested under the Convention. More 
thought could be given to the role of data banks. 
Done at Brussels, 21 May 1986. 
The Chairman 
of the Economic and Social Committee 
Gerd MUHR 
Opinion on the proposal for a Council Directive on water quality objectives for chromium 
(86/C 207/04) 
On 20 January 1986 the Council decided to consult the Economic and Social Committee, under 
Articles 100 and 235 of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
(') OJ No C 351, 31. 12. 1985, p. 33.