Consultation Update – health and safety standards across the “agri-food chain”
Proposal for a new Regulation of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products to replace Regulation (EC) No 882/2004.
On the 6 May 2013, the European Commission adopted a proposal for a draft regulation on official controls and other official activities performed which aims to strengthen the enforcement of health and safety standards across the “agri-food chain”.
The Department of Agriculture, Food and the Marine (DAFM), the Department of Health (DoH) and the Food Safety Authority of Ireland (FSAI) invited comments in respect of the proposed Regulation to be submitted to the FSAI by the 9th September 2013 (subsequently extended to the 27th September).
Views from the general public were invited through the websites of the DAFM, the DoH and the FSAI. The launch of the consultation was accompanied by an FSAI press release which received some media coverage in print media and on radio.
In addition the following were specifically notified of the consultation:
- Relevant contacts in the DAFM and the DoH.
- Subscribers to the consultation notifications on the FSAI website. This includes private individuals, business operators, industry representative groups, competent authorities and other interested parties some of which have email addresses outside of the Republic of Ireland.
- Official agencies with whom the FSAI has service contracts or Memoranda of Understanding.
- Members of the FSAI industry fora.
Members of the FSAI Retail, Food Service and Artisan Fora.
The DAFM also had discussions and meetings with food industry representatives including Meat Industry Ireland, the Irish Association of Pigmeat Processors, the Irish Egg Association, the Animal and Plant Health Association and with the feed industry representatives, the Irish Grain and Feed Association at which the industry comments on the proposed Regulation were received.
|Health Service Executive Environmental Health Service|
|HSE Official Food Microbiology Laboratories (six)|
|HSE Public Analyst Laboratories (three)|
|County Councils (27) and City Council (one)|
|The Department of Agriculture, Food and the Marine|
|Revenue Commissioners Custom and Excise Service|
|Radiological Protection Institute of Ireland|
|The Marine Institute|
|The Sea-Fisheries Protection Authority|
|The National Standards Authority of Ireland|
|Bord Iascaigh Mhara|
|National Standards Authority|
In addition to the above consultation process, the FSAI gave presentations on the proposed regulation to the following:
- The FSAI industry fora including the Artisan, Food Service and Retail Fora
- Official agencies including the HSE Environmental Health Service, the HSE laboratories and local authority veterinary inspectors
- The FSAI Food Safety Consultative Council
- The FSAI Cross-Agency Import Control Working Group
DAFM officials attended the Oireachtas Joint Committee on Agriculture, Food and the Marine on 8 October 2013 for a detailed discussion on the proposed new regulations.
Response to Consultative Process
The response to the consultative process was limited and showed that there may be a need for further consultation and informal on-going dialogue on specific issues. Four responses were received. This does not include the submissions from the competent authorities for food, feed, plant health and animal health which were submitted as part of DAFM, DoH and the FSAI competent authority consultation.
The four submissions to the public consultation were from:
- The Irish Grain and Feed Association
- The Marine Institute
- Meat Industry Ireland and the Irish Association of Pig Meat Producers
- BWG Foods
Of the three industry submissions two were from industry representative organisations and one was on behalf of an individual food business.
None of the submissions raised an outright objection to the draft regulation. Many of the submissions raised the need for further consultation and feedback on the draft regulation and its implementation.
The largest number of comments related to the proposals for inspection fees. The three industry submissions included specific comments on fees relating to full cost recovery, exemptions for micro enterprises and the need for transparency, fee reduction for consistently compliant operators and consultation on the fee calculation method.
One of the submissions had comments/issues on the changes to import controls.
There were also some comments on other Articles not related to inspection fees in two of the industry submissions.
Negotiations at EU level
Discussions on the proposal started at Council level in June 2013 under the Irish Presidency of the EU and were continued in July under the Lithuanian Presidency. Up to end 2013, there were six European Council Working Party meetings of the joint Working Party of Veterinary Experts (Public Health) and Phytosanitary Experts on the proposal. Up to end 2013, Articles 1 to 61 and 91 to 99 were examined. Greece took over the Presidency of the EU on 1 January 2014 and its first Council Working Group meeting was held on 15 and 16 January 2014 and a second meeting on 4 and 5 of February. Articles 62 -90, Article 124-128 and 134-136 were examined at these meetings.
It is proposed to have a further four meetings during its Presidency.
Many Member States (MS) expressed preliminary positive opinions on an integrated and a risk-based approach on official controls, however, the need for clarification and improvement of the text and for further discussion at technical level was raised. Some of the particular points raised were as follows:
Scope (Article 1): Some MS expressed concern about extending official controls to forestry propagating material and/or pesticide application equipment. There was also some opposition to extending to the plant health and/or plant reproductive material sectors. Several MS requested clarification with regard to official controls to be performed in some areas (e.g. use of GMOs, veterinary medicinal products or organic products).
Definitions (Article 2): Several MS outlined the need to review some definitions and also add others, including taking better account of the specificity of the plant health sector. A large number of MS requested more clarity on the division between “official controls” and “other official activities”.
Delegated acts and implementing acts: Several MS questioned the high usage of both delegate acts and implementing acts within the proposal as well as the broad and unclear scope of several of them. Some MS outlined that some of the elements to be delegated were in certain cases essential and should therefore be included in the basic text of the proposal. There was also some discussion on whether some of the delegated acts should be replaced by implementing acts.
Financing of official controls (Articles 76 – 84): Most MS were against the proposals in their current form. In particular, MS were against the proposal to exclude all micro businesses from fees, as it would mean on average 90% of businesses would be excluded from charges which would appear to be in conflict with the aim of collecting fees to recover the costs incurred in relation to official controls. Several MS want flexibility to allow them to decide from which operators they should collect fees and the level at which those fees should be set. Others recognised that this would distort the single market. Many MS pointed out that any fees collected must be given in to the central exchequer and there is no guarantee that they will be released exclusively to fund the carrying out of official controls.
Sampling, analyses, test and diagnoses and laboratories (Articles 33 to 41 and 91 to 99): Several MS raised questions on the scope of the accreditation of official laboratories but generally welcomed the planned derogations from accreditation. However, a few MS voiced concerns with regard to some of these derogations. Several MS questioned the proposed hierarchy in the methods to be used by these laboratories. Many MS requested clarification of the role and responsibilities of the operators and of competent authorities regarding the issue of the second expert opinion. Furthermore, several MS expressed concerns regarding the transparency and the absence of involvement of MS in the procedure for designating EU reference laboratories.
Import controls (Articles 42 to 61): Numerous queries and requests for clarification were raised in relation to Import Controls. Details as follows:
- Several MS requested a clearer reference to a risk-based approach and suggested reordering the Articles at the beginning of the chapter.
- Many MS requested clarification on part of the text to take better account of the specificities of the plant health sector (e.g. to specify better the places where controls can be carried out).
- Several MS specifically requested that the official veterinarian be clearly designated as responsible for import controls not only on animals but also on products of animal origin – however, some MS did not support this and outlined that flexibility should be left with individual MS on this issue.
- Some MS requested clarification with regard to the use of TRACES system by national competent authorities of the border control posts and its compatibility with possibly existing national systems.
- Several MS also indicated that they should not be required to provide information on the equipment in place and/or the volume of animals and goods handled per year by each border control post.
Some of the other points raised by MS which will require additional discussion in the future related to the following issues:
- The concept of a single competent authority and the delegation of tasks
- Prior notification of controls
- Reporting following an official control
- Right of appeal
- Disclosure to the public of information on official controls
- The need to delete transitional provisions for EU reference laboratories acting within the framework of the authorisation procedures for genetically modified food or feed and for feed additives (Articles 148 and 149) as those EU reference laboratories do not act within the framework of official controls or other official activities
Official certification (Articles 85-90) Many MS had difficulties with the use of the term “official” in relation to official attestations, as the term “official” should only be reserved for activities carried out by the competent authorities. There were also some concerns about the role of delegated bodies in certification. The Commission clarified that this proposal will only apply to certificates which cover the rules in Article 1.2 of this proposal and also to matters which are the subject of bilateral agreement between the EU and Third Countries. The Regulation does not apply to certificates which cover items the subject of bilateral agreements between individual MS and Third Countries and which go beyond the scope of Article 1.2.
he main concern was in relation to Article 136 which says that penalties must be effective, proportionate and dissuasive. However, 136.2 then says that in cases of intentional violation of the rules, financial penalties must “at least offset the economic advantage sought through the violation”
While MS approved the intention to apply stiff penalties for fraud, all who spoke were against this paragraph on the grounds that in cases of criminal activity it interfered with the independence of the courts and in other cases, the amount of the penalty would be impossible to calculate. The general view was that this paragraph should be deleted.
Following publication of the proposed Regulation in May 2013 a joint working group of DAFM, DoH and the FSAI was established to formulate the Irish position for the Council working group meetings. This group meets at regular intervals to review the Articles for discussion at forthcoming Council meetings and prepare the agreed Irish position. The Irish position takes into account the views of the competent authorities and where relevant those from stakeholders received through the public consultation and at other fora such as competent authority meetings with industry representatives.
As well as making comment during the working group meetings Ireland has submitted written comments to the Council on Articles 1-24 and a separate submission on Articles 25-41 and 91-99. Further submissions will be made by Ireland. These submissions will be made publicly available by the Council along with other Member States submissions.
DAFM, DoH and the FSAI will continue to analyse and discuss the proposed regulation with a view to preparing a full regulatory impact analysis document . The regulatory impact analysis document will be a live, on-going document and will therefore, be subject to continuous review. In the first instance it will seek to set out the issues that will inform the negotiation process through on-going consultation with all relevant stakeholders.
The regulatory impact analysis document will be published on the websites of DAFM, DoH and the FSAI.