ANNEX II
OFIS templates as referred to in Article 9
1.
Template for a standard notification on suspected or established non-compliance
*First language:
Second language:
A.
Notifying Member State:
1)
Country:
2)
Competent authority – contact details:
*3)
Date of notification (DD/MM/YYYY):
*4)
Reference
B.
Notified Member State or Member States:
*1)
Country/countries:
2)
Competent authority/authorities – contact details:
C.
Product:
*1)
Category of product:
*2)
Product/trade name:
*3)
Country of origin:
4)
Description of the product (packaging size and form, etc.) – please attach copied or scanned seal or label:
5)
Identification of the lot (e.g. lot number, delivery number, delivery date, etc.):
6)
Other information:
D.
Traceability:
Please describe in detail the complete supply chain:
1)
Producer – contact details – competent authority or, where appropriate, the control authority or control body:
2)
Processor/seller in the country of origin – contact details – competent authority or, where appropriate, the control authority or control body:
3)
Importer in the notifying country – contact details – competent authority or, where appropriate, the control authority or control body:
4)
Wholesaler – contact details – competent authority or, where appropriate, the control authority or control body:
5)
Retailer or other operator in the notifying country, where the non-compliance has been detected – contact details – competent authority or, where appropriate, the control authority or control body:
Authority (ies):
Other actors:
E.
Non-compliance, suspicion of non-compliance, other problem raised:
*1)
Nature of the non-compliance/suspicion of non-compliance/other problem raised.
Which non-compliance/suspicion of non-compliance/other problem raised has been identified?:
*In what aspect does it represent a non-compliance/suspicion of non-compliance/other problem raised with Regulation (EU) 2018/848 of the European Parliament and of the Council ( 1 ) ?:
2)
Context of the detection of the non-compliance/suspicion of non-compliance/other problem raised – please attach a copy of invoice or other supporting documents:
Date of the detection of the non-compliance/suspicion of non-compliance/other problem raised (DD/MM/YYYY):
Place of the detection of the non-compliance/suspicion of non-compliance/other problem raised:
3)
Analysis of the samples/tests (if any) – please attach a copy of analysis report:
Date of sampling/testing (DD/MM/YYYY):
Place of sampling/testing:
Date of the analysis – report (DD/MM/YYYY):
Details (name of the laboratory, methods used, results):
Name of the substances found:
Level of the residues detected:
Is the level above the threshold allowed in food (or feed) in general?:
Is the level for labeling of GMO-contents overshot?:
F.
Market influence:
1)
Has the product been withdrawn from the market, blocked or marketed?:
2)
Which actors have been already informed?:
3)
Are other Member States affected? If so, which Member States?:
G.
Measures taken:
1)
Have any voluntary measures been taken (on the product/operator/market)?:
2)
Have any compulsory measures been taken?:
3)
What is the scope of the measures (national, regional, exports, etc.)?:
4)
Date of entry into force: (DD/MM/YYYY):
5)
Duration (in months):
6)
Justification/legal basis of the measures:
7)
Which competent authority or, where appropriate, control authority or control body has adopted the measures?:
H.
Other information/Evaluation:
I.
Annexes:
Copied or scanned documentation of the product (seal, label, etc.). Copy of invoice, documentary account or document of transport or delivery order. Analysis report and/or any other relevant documents:
2.
Template for a standard reply to a standard notification on suspected or established non-compliance
*First language:
Second language:
Version of reply:
A.
Notified Member State:
1)
Country:
2)
Competent authority – contact details:
*3)
Date (DD/MM/YYY):
*4)
Reference:
B.
Notification:
1)
Country:
2)
Competent authority – contact details:
*3)
Date of notification (DD/MM/YYYY):
*4)
Reference of notification (same as in point A.4 of the notification):
*5)
Product:
6)
Non-compliance/suspicion of non-compliance/other problem raised:
C.
Investigation
1)
Which competent authority(-ies) or, where appropriate, control authority(-ies) and/or control body(-ies) are/were in charge of the investigation?:
2)
Describe cooperation between the different operators and competent authority(-ies) or, where appropriate, control authority(-ies) and/or control body(-ies) involved, in the different countries involved (if any)?:
3)
Which investigation methods/procedures have been used?:
For instance, have the operators concerned been submitted to a specific control?:
Have samples been taken and analysed?:
4)
What is the outcome of the investigation?:
What are the results of the inspections/analyses (if any)?:
Has the origin of the non-compliance/suspicion of non-compliance/other problem raised been cleared out?:
What is your assessment on the seriousness of the non-compliance/suspicion of non-compliance/other problem raised?:
5)
Have the origin of the contamination/non-compliance/suspicion of non-compliance/other problem raised and the responsibility of the actors been clearly identified and established?:
Have the operators identified been involved in other non-compliance/suspicion of non-compliance/other problem raised cases in the last 3 years?:
D.
Measures and penalties:
*1)
What preventive and corrective measures have been taken (e.g. as regards the distribution/circulation of the product on the Union market and third-country markets)?:
2)
What actions in case of non-compliance/suspicion of non-compliance/other problem raised were taken on the operators and/or the products concerned? ( 2 ) :
*Mode of actions (written form, warning, etc.)?:
Was the certification of the producer/processor limited, suspended or withdrawn?:
Date of entry into force of the actions (if any) (DD/MM/YYYY):
Duration of the actions (if any) (in months):
Competent authority or, where appropriate, control authority and/or control body which adopted and applied the actions (if any):
3)
Are additional inspections planned at the operators concerned?:
4)
What other measures are the competent authority or, where appropriate, the control authority or control body planning to prevent the occurrence of similar cases?:
E.
Other information:
F.
Annexes:
3.
Template for an alert notification
1.
Alert origin and status
Alerting Country:
Competent authority:
2.
Alerted country or countries
Country
Competent authority
Coordinator
Scope
3.
Non-compliance , fraud, other issue and suspicion thereof (hereinafter "non-compliance")
Title:
Description:
What is your assessment on the seriousness of the non-compliance?
Which actors have been already informed?
Detection context
Date:
Place:
Person/body detecting the non-compliance:
Union legislation at stake (reference(s)):
4.
Product traceability
Description
Name:
Brand/trade name:
Other aspects:
Consignment
Consignment/lot/delivery number:
Country of origin:
Total net/gross weight, volume:
Other information:
Supply chain – description of operators
(name – type – contact details – control body/control authority (with contact details))
5.
Measures taken
0.
No action yet (please explain why)
1.
Prohibition of the placing on the market of the product(basis – date – quantities)
2.
Downgrading product to conventional (basis – date – quantities – from/to)
3.
Suspension of certificate of the operator (from/to – scope)
4.
De-certification of operator (as from)
5.
Other measures (please describe)
6.
Other information
7.
Files
4.
Template for a standard international notification on suspected or established non-compliance
Notifying country:
Country:
Notified Actor details:
Notified Actor Type:
Actor code:
Actor version:
Name:
Street:
Postcode:
Locality:
Telephone:
Mail:
Fax
Website link:
URL site:
Comments:
A.
Product:
*1)
Country of origin:
*2)
Category of product:
*3)
Product/trade name:
4)
Description of the product (packaging size and form, etc.) – please attach copied or scanned seal or label:
5)
Identification of the lot (e.g. lot number, delivery number, delivery date, etc.):
6)
Other information:
B.
Traceability:
Please describe in detail the complete supply chain:
1)
Producer – contact details – control authority or control body:
2)
Processor/seller/exporter in the country of origin – contact details – control authority or control body:
3)
Importer in the notifying country – contact details – control authority or control body:
4)
Wholesaler – contact details – control authority or control body:
5)
Retailer or other operator in the notifying country, where the non-compliance has been detected – contact details – control authority or control body:
Authority (ies):
Other actors:
C.
Non-compliance, suspicion of non-compliance, other problem raised:
*1)
Nature of the non-compliance/suspicion of non-compliance/other problem raised.
Which non-compliance/suspicion of non-compliance/other problem raised has been identified?:
*In what aspect does it represent a non-compliance/suspicion of non-compliance/other problem raised with Regulation (EU) 2018/848 of the European Parliament and of the Council ( 3 ) ?:
2)
Context of the detection of the non-compliance/suspicion of non-compliance/other problem raised – please attach a copy of invoice or other supporting documents:
Date of the detection of the non-compliance/suspicion of non-compliance/other problem raised (DD/MM/YYYY):
Place of the detection of the non-compliance/suspicion of non-compliance/other problem raised:
3)
Analysis of the samples/tests (if any) – please attach a copy of analysis report:
Date of sampling/testing (DD/MM/YYYY):
Place of sampling/testing:
Date of the analysis – report (DD/MM/YYYY):
Details (name of the laboratory, methods used, results):
Name of the substances found:
Level of the residues detected:
Is the level above the threshold allowed in food (or feed) in general?:
Is the level for labeling of GMO-contents overshot?:
D.
Market influence:
1)
Has the product been withdrawn from the market, blocked?:
2)
Which actors have been already informed?:
3)
Are other Member States affected? If so, which Member States?:
E.
Measures taken:
1)
Have any voluntary measures been taken (on the product/operator/market)?:
2)
Have any compulsory measures been taken?:
3)
What is the scope of the measures (national, regional, exports, etc.)?:
4)
Date of entry into force: (DD/MM/YYYY):
5)
Duration (in months):
6)
Justification/legal basis of the measures:
7)
Which control authority or control body has adopted the measures?:
F.
Other information/Evaluation:
G.
Annexes:
Copied or scanned documentation of the product (seal, label, etc.). Copy of invoice, documentary account or document of transport or delivery order. Analysis report and/or any other relevant documents:
-----------
(*)
Mandatory fields.
( 1 ) Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 ( OJ L 150, 14.6.2018, p. 1 ).
( 2 ) Measure pursuant to Articles 29(1) and (2), 41(1) to (4) and 42 of Regulation (EU) 2018/848.
( 3 ) Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 ( OJ L 150, 14.6.2018, p. 1 ).