Sanctions Regulation Legislative Decree No. 133 of 14 September 2009 for breach of the provisions of Regulation (EC) n°1907/2006.
1- PENALTIES FOR REGISTRATION AND NOTIFICATION OF SUBSTANCES (Breach Article 6-7-8-12-17-18)
-The manufacturer or importer or distributor or only representative is obliged to register at concentrations greater than 1 ton / year:
If this is not the case, it is punished with a penalty of 15,000 to 90,000 euros.
-The manufacturer or importer or distributor or only representative is obliged to notify:
If this is not the case, it is punished with a penalty of 15,000 to 90,000 euros.
- The registrant at the time of registration shall not be notified or communicated incorrectly the information being punished with a sanction of 10,000 to 60,000 euros.
- The manufacturer of a site-insulated or transported intermediate substance in quantities equalt to or greater than 1 tonne/year which does not comply with or fails to comply correctly with the registration shall be punished with a penalty of 10,000 to 60,000 euros.
- Anyone who fulfills the obligations incumbent on importers without being designated as an only representative will have to pay a fine from 10,000 to 60,000 euros.
2 - PENALTIES FOR THE REQUEST OF EXEMPTION FROM THE RECORDING OBLIGATION FOR RESEARCH AND DEVELOPMENT ACTIVITIES (Article 9)
-The manufacturer, importer, distributor, only representative or producer of articles shall be obliged to notify the Agency of the information required by Article 9 (2) for the exemption.
If he does not fulfill these obligations he has to pay a penalty of 3,000 to 18,000 euros.
-If the manufacturer, the importer, the only representative or the manufacturer of articles manufactures or imports substances / articles within two weeks of notification or does not meet the conditions set by the Agency, he has to pay a fine of 3,000 to 18,000 euros.
3 - PENALTIES FOR THE BREACH OF OBLIGATIONS TO BE COMMUNICATED BY THE TONNING BALL (Art. 12-22-24)
-The manufacturer, the importer, the only representative who fails to supply the information to be notified on the basis of the tonnage referred to in Article 12, or a substance notified under Directive 67/548 / EEC in accordance with Article 24 Complies with the obligation to provide additional information is punished with a fine from 15,000 to 90,000 euros.
-If the registrant does not comply or does not comply with any changes, changes, new uses, new information, he will have to pay a penalty of 10,000 to 60,000 euros.
4. PENALTIES FOR THE BREACH OF REQUIREMENTS FOR THE REPORT FOR CHEMICAL SAFETY AND RISK REDUCTION MEASURES (Article 14)
- The registrant of the substance that is recorded in quantities exceeding 10 tonnes / year which does not perform or partially carry out a chemical safety report will be punished with a penalty of 15,000 to 90,000 euros.
- The declarant who fails to comply with the obligations to apply the necessary measures to adequately control the risks identified in the chemical safety assessment and who does not keep an up-to-date version of the chemical safety report must pay a fine from 10,000 to 60,000 euros.
5- VIOLATION OF THE OBLIGATIONS CONCERNING MANUFACTURING AND IMPORTING SUBSTANCES BY THE DECLARATION (Article 21)
- The declarant who initiates or continues manufacturing / importing in the presence of a contrary indication of the Agency is punished with a sanction of 10,000 to 60,000 euros
6- VIOLATION OF THE DATA SHARING OBLIGATIONS AND PROVISIONS TO AVOID SUPERFLUENT EXPERIMENTS ON VERTEBRED ANIMALS (Art. 25-26)
- The petitioner who carries out animal testing where it is unnecessary has to pay a penalty of 10,000 to 60,000 euros.
- The registrant of a substance not subject to a transitional or transient procedure which has not carried out a preliminary registration must make inquiries prior to registering the substance on request of the Agency, if he fails to comply with these obligations must pay a sanction of 3,000 18,000 euros.
7- VIOLATION OF THE OBLIGATIONS CONCERNING THE DATA DIVISING FROM EXPERIMENTAL TESTS (Article 30)
If the owner of a vertebrate animal testing or animal testing on non-vertebrate animals refuses to provide evidence of the cost of the study or study to one or more participants, it must pay a sum of 10,000 to 60,000 euros.
8- INFRINGEMENT OF INFORMATION OBLIGATIONS INSIDE THE APPROVAL CATEGORY (Art. 7-31-32-33-34-35-36)
-The manufacturer, importer or only representative of articles that does not comply with the obligation to provide appropriate instructions to the recipient of articles must pay a fine from 10,000 to 60,000 euros.
-The supplier of a substance or mixture that does not provide the safety data sheet to each actor in the supply chain or an actor in the supply chain that does not include the relevant exposure scenarios attached to the safety data sheet (if a chemical safety report has been carried out) is punished with an administrative sanction of 10,000 to 60,000 euros.
-If the supplier of a substance or mixture provides the safety data sheet in a language other than that of the country where the product is placed on the market or incomplete it has to pay a penalty of 3,000 to 18,000 euros.
-If the supplier of a substance or mixture does not have to provide the safety data sheet but does not disclose the information as per art. 33 such as registration number and information concerning substances subject to authorization or some restriction, must pay a fine from 10,000 to 60,000 euros.
-The supplier of an article must provide information along the supply chain regarding the article that is subject to authorization if it does not have to pay a penalty from 5,000 to 30,000 euros.
-The supply chain actor has the obligation to provide information upstream of the chain, if this does not happen he will be punished with a penalty of 3,000 to 18,000 euros.
-The employer must allow workers full access to information regarding the substances and mixtures they use, if this does not happen, it will be punished with a penalty of 15,000 to 90,000 euros.
-If the manufacturer, importer, only representative, downstream user or distributor decides to stop the business or transfer the company, the party that assumes corporate responsibility is obliged to retain the information, if this does not happen will be punished With a penalty of 3,000 to 18,000 euros.
9- VIOLATION OF THE OBLIGATIONS CONCERNING THE PERFORMANCE OF DOWNSTREAM USERS (Art. 37-38-39)
- The downstream user of a substance or a mixture must comply with the obligations of the chemical safety assessment, for the downstream user to produce his own chemical safety report. If the downstream user does not recommend appropriate measures and does not follow the above obligations, he will have to pay a penalty of 10,000 to 60,000 euros.
-The downstream user must update and keep the chemical safety report available if he does not disclose information to the agency for use that deviates from the use stated in the registration, or to have a classification that differs or is Failure to comply with the limits indicated to comply with the requirements of Article 37 must pay a fine from 5,000 to 30,000 euros.
- If there are any further changes in the use you want to register, you must immediately inform the Agency if this is not the case you have to pay a penalty of 3,000 to 18,000 euros.
10- VIOLATION OF OBLIGATIONS RELATING TO THE INFORMATION ON THE ASSESSMENT OF SUBSTANCES (Articles 46-49)
- The declarant who fails to comply with the obligation to provide additional information over time and fails to comply with the provisions on risk reduction measures for isolated on-site intermediates must pay a fine from 10,000 to 60,000 euros.
-If the declarant does not disclose additional information to the Authorities regarding isolated intermediates he has to pay a fine of 2,000 to 12,000 euros.
11- VIOLATION OF THE OBLIGATIONS CONCERNING THE DECLARATION THAT HAS FAILED TO MANUALLY OR IMPORT (Article 50)
- If the declarant has ceased to manufacture or import a substance / article or if the user has stopped using it, it is necessary to give notice to the Agency and no longer may be required to provide information on this substance if the communication does not You have to pay a penalty of 5,000 to 30,000 euros.
-The Authority may request additional information if it establishes that there may be long-term risks to health and the environment, if they are not supplied a penalty of 10,000 to 60,000 euros is payable.
12 - INFRINGEMENT OF OBLIGATIONS RELATING TO THE MARKETING OF A SUBSTANCE FOR A PARTICULAR USE. (Article 56)
-The manufacturer, importer, only representative or downstream user who places on the market or uses a substance included in Annex XIV subject to authorization is punished by a sanction of 40,000 to 150,000 euros with the exception of substances referred to in art. 56.
13- VIOLATION OF THE OBLIGATIONS RELATING TO THE EXEMPTION OF AUTHORIZATIONS (Art. 60-65-66)
-The holder of an authorization must reduce the exposure to the lowest technically and practically as low as possible, and must provide the authorization number on the label of the substances being blended, if this does not happen it must pay a fine from 10,000 to 60,000 euro.
- Downstream users should notify the Agency if they use substances authorized to fall within the scope of Article 56 (2), if they do not have to pay a penalty of 5,000 to 30,000 euros.
14 - VIOLATION OF RESTRICTION OBLIGATIONS (Art. 67)
-The manufacturer, the importer, the exclusive representative or downstream user who places on the market or uses a substance as such, either in blend or in an article which does not comply with the conditions of the restrictions set out in Annex XVII of the Regulation outside the cases Referred to in Article 67, shall be punished with the arrest of up to three months and with the fine from 40,000 to 150,000 euros
15 - VIOLATION OF OBLIGATIONS RELATING TO INFORMATION TO BE NOTIFIED TO AGENCY (Article 113)
- Any manufacturer, producer or importer or group of manufacturers or processors or importer or only representative who places on the market a substance which falls within the scope of the registration obligation and between substances which fall within the scope of Hazardous substances according to Directive 67/548 / EEC, in concentrations above the limits laid down in Directive 1999/45 / EC and do not communicate or communicate to the Agency improperly the information in accordance with art. 113 has to pay a penalty of 10,000 to 60,000 euros.
- Any manufacturer, manufacturer or importer or group of manufacturers or manufacturers of articles or importer or only representative who does not update the information to the Agency shall pay a fine of 5,000 to 30,000 euros.