title: Commission Implementing Regulation (EU) 2019/1997 of 29 November 2019 reopening the investigation following the judgment of 19 September 2019, in Case C‐251/18 Trace Sport SAS, with regard to Council Implementing Regulation (EU) No 501/2013 of 29 May 2013 extending the definitive anti-dumping duty imposed by Implementing Regulation (EU) No 990/2011 on imports of bicycles originating in the People’s Republic of China to imports of bicycles consigned from Indonesia, Malaysia, Sri Lanka and Tunisia, whether declared as originating in Indonesia, Malaysia, Sri Lanka and Tunisia or not

text:
                  2.12.2019

                  EN

                  Official Journal of the European Union

                  L 310/29

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1997
         of 29 November 2019
         reopening the investigation following the judgment of 19 September 2019, in Case C‐251/18 Trace Sport SAS, with regard to Council Implementing Regulation (EU) No 501/2013 of 29 May 2013 extending the definitive anti-dumping duty imposed by Implementing Regulation (EU) No 990/2011 on imports of bicycles originating in the People’s Republic of China to imports of bicycles consigned from Indonesia, Malaysia, Sri Lanka and Tunisia, whether declared as originating in Indonesia, Malaysia, Sri Lanka and Tunisia or not
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union, and in particular Article 266 thereof,
         Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1) (‘the basic Regulation’) and in particular Article 13 thereof,
         Whereas:
         1.   PROCEDURE

                     (1)

                     On 26 September 2012, the Commission, by way of Regulation (EU) No 875/2012 (2), initiated an investigation concerning the possible circumvention of the anti-dumping measures imposed by Council Implementing Regulation (EU) No 990/2011 on imports of bicycles originating in the People’s Republic of China (‘the PRC’) following an expiry review pursuant to Article 11(2) of Regulation (EC) No 1225/2009.

                     (2)

                     On 5 June 2013, the Council extended the anti-dumping duty imposed by Council Implementing Regulation (EU) No 990/2011 to imports of bicycles consigned from Indonesia, Malaysia, Sri Lanka and Tunisia, whether declared as originating in Indonesia, Malaysia, Sri Lanka and Tunisia or not, by Council Implementing Regulation (EU) No 501/2013 of 29 May 2013 (3) (the ‘contested regulation’).

                     (3)

                     By its judgment of 19 March 2015, in Case T‑413/13 City Cycle Industries v Council, the General Court of the European Union annulled Article 1(1) and (3) of Council Implementing Regulation (EU) No 501/2013, in so far as that regulation concerns City Cycle Industries (‘City Cycle’).

                     (4)

                     The General Court firstly analysed, in paragraphs 82 to 97 of that judgment, the evidence communicated by City Cycle during the investigation. It concluded that that evidence did not show that City Cycle was in fact a bicycle exporter of Sri Lankan origin or that it met the criteria laid down in Article 13(2) of the basic Regulation. In the second place, in paragraph 98 of the judgment under appeal, the General Court nonetheless held that the Council had no evidence from which it could properly conclude, in recital 78 of the regulation at issue, that City Cycle was involved in transhipment operations. In the third place, in paragraph 99 of the judgment under appeal, the General Court stated that it could not be ruled out that the practices, processes or work for which there was insufficient due cause or economic justification other than the imposition of the initial anti-dumping duty, within the meaning of the second subparagraph of Article 13(1) of the basic Regulation, included City Cycle’s engagement in transhipment operations.

                     (5)

                     On 26 January 2017, the appeals brought forward against the judgment of the General Court of 19 March 2015, were dismissed by judgment of the Court of Justice in Joined Cases C-248/15P, C-254/15P and C-260/15P (4), City Cycle Industries v Council.

                     (6)

                     Following that judgment of the Court of Justice, the Commission partially reopened the anti-circumvention investigation concerning imports of bicycles consigned from Sri Lanka, whether declared as originating in Sri Lanka or not that led to the adoption of the contested Regulation and resumed it at the point at which the irregularity occurred. The reopening was limited in scope to the implementation of the judgment of the Court of Justice with regard to City Cycle. As a result of this reopening the Commission adopted Implementing Regulation (EU) 2018/28 of 9 January 2018 re-imposing a definitive anti-dumping duty on imports of bicycles whether declared as originating in Sri Lanka or not from City Cycle Industries.

                     (7)

                     On 19 September 2019 in the context of a preliminary reference request made by the Rechtbank Noord-Holland, the Court of Justice ruled in Case C-251/18 Trace Sport SAS that Council Implementing Regulation (EU) No 501/2013 is invalid in so far as it concerns imports of bicycles shipped from Sri Lanka, whether declared as originating in Sri Lanka or not. The Court of Justice concluded that Council Implementing Regulation (EU) No 501/2013 did not contain any individual analysis of circumvention practices in which Kelani Cycles and Creative Cycles may have been engaged. The Court of Justice found that the conclusion as to the existence of transshipment operations in Sri Lanka could not legally be based only on the two findings expressly made by the Council, that is, first, that there had been a change in the pattern of trade between the Union and Sri Lanka and, second, that some of the exporting producers had failed to cooperate. On this basis the Court of Justice declared Council Implementing Regulation (EU) No 501/2013 invalid in so far as it concerns imports of bicycles shipped from Sri Lanka, whether or not declared as originating in that country.

                     (8)

                     In accordance with Article 266 of the Treaty on the Functioning of the European Union, the Union’s institutions must take the necessary steps to comply with the judgment of the Court of Justice of the European Union.

                     (9)

                     It follows from the case-law that where a judgment of the Court of Justice annuls a regulation imposing anti-dumping duties or declares such a regulation to be invalid, the institution called upon to take such measures for the purpose of implementing that judgment does have the option of resuming the proceeding at the origin of that regulation, even if that option is not expressly set out in the applicable legislation (5).

                     (10)

                     Furthermore, except where the irregularity found has vitiated the entire proceeding with illegality, the institution concerned has the option, in order to adopt an act intended to replace the act that has been annulled or declared invalid, to resume that proceeding only at the stage when the irregularity was committed (6). That implies in particular that in a situation where an act concluding an administrative procedure is annulled, that annulment does not necessarily affect the preparatory acts, such as the initiation of the anti-circumvention procedure by Commission Regulation (EU) No 875/2012.

                     (11)

                     Thus, the Commission has the possibility to remedy the aspects of Council Implementing Regulation (EU) No 501/2013 which led to its declaration of invalidity, leaving those parts which were not affected by the judgment of the Court unaffected. (7)

                     (12)

                     The Commission has therefore decided to reopen the anti-circumvention investigation in order to correct the illegality identified by the Court of Justice.

                     (13)

                     Given that Commission Implementing Regulation (EU) 2018/28 of 9 January 2018 is not affected by the irregularity identified by the Court of Justice in Case C-251/18, the definitive anti-dumping duties on imports of bicycles whether declared as originating in Sri Lanka or not from City Cycle Industries are not covered by this proceeding.

               2.   REOPENING PROCEDURE

         2.1.   Reopening

                     (14)

                     In view of the above, the Commission reopens the anti-circumvention investigation concerning imports of bicycles and other cycles (including delivery tricycles, but excluding unicycles), not motorised, CN codes ex 8712 00 30 and ex 8712 00 70 (TARIC codes 8712003010 and 8712007091), consigned from Indonesia, Malaysia, Sri-Lanka and Tunisia, whether declared as originating in Indonesia, Malaysia, Sri Lanka and Tunisia or not, that led to the adoption of Council Implementing Regulation (EU) No 501/2013 and resumes it at the point at which the irregularity occurred by publishing this Regulation in the Official Journal of the European Union.

                     (15)

                     The reopening is limited in scope to the implementation of the judgment of the Court of Justice in Case C-251/18 Trace Sport SAS. In that judgment, the illegality identified by the Court of Justice pertains to the obligation for the institutions of the Union to bear the burden of proof arising from Article 13(3) of Regulation (EU) 2016/1036 as it stood at the time.

                     (16)

                     Therefore, the lack of sufficient reasoning in Council Implmenting Regulation (EU) No 501/2013 concerning the available evidence on the existence of circumventing practices in Sri Lanka must be corrected.

               2.2.   Registration

                     (17)

                     Pursuant to Article 14(5) of the basic Regulation, imports of the product under investigation shall be made subject to registration in order to ensure that, should the investigation result in findings of circumvention, anti-dumping duties of an appropriate amount can be levied from the date on which registration of such imports was imposed.

                     (18)

                     The Commission, by regulation, may direct Customs authorities to cease registration in respect of imports into the Union of products manufactured by producers having applied for an exemption of registration and having been found to fulfil the conditions for an exemption to be granted.

               2.3.   Written submission

                     (19)

                     Interested parties are invited to come forward and to make their views known, submit information and provide supporting evidence on issues pertaining to the reopening of the investigation within 20 days of the date of publication of this Regulation in the Official Journal of the European Union.

               2.4.   Possibility to be heard by the Commission investigation services

                     (20)

                     Interested parties may request to be heard by the Commission investigation services. Any request to be heard should be made in writing and should specify the reasons for the request. For hearings on issues pertaining to the reopening of the investigation the request must be submitted within 15 days of the date of publication of this Regulation in the Official Journal of the European Union. Thereafter, a request to be heard must be submitted within the specific deadlines set by the Commission in its communication with these parties.

               2.5.   Instructions for making written submissions and sending correspondence

                     (21)

                     Information submitted to the Commission for the purpose of trade defence investigations should be free from copyright. Interested parties, before submitting to the Commission information and/or data which is subject to third party copyright, must request specific permission to the copyright holder explicitly allowing (a) the Commission to use the information and data for the purpose of this trade defence proceeding; and (b) to provide the information and/or data to interested parties to this investigation in a form that allows them to exercise their rights of defence.

                     (22)

                     All written submissions and correspondence provided by interested parties for which confidential treatment is requested shall be labelled ‘Limited’ (8).

                     (23)

                     Interested parties providing ‘Limited’ information are required to furnish non-confidential summaries of it pursuant to Article 19(2) of the basic Regulation, which will be labelled ‘For inspection by interested parties’. These summaries should be sufficiently detailed to permit a reasonable understanding of the substance of the information submitted in confidence. If an interested party providing confidential information does not furnish a non-confidential summary of it in the requested format and quality, such information may be disregarded.

                     (24)

                     Interested parties are invited to make all submissions and requests by e-mail or TRON.tdi (https://webgate.ec.europa.eu/tron/TDI) (9) including scanned powers of attorney and certification sheets. By using e-mail or TRON.tdi, interested parties express their agreement with the rules applicable to electronic submissions contained in the document ‘CORRESPONDENCE WITH THE EUROPEAN COMMISSION IN TRADE DEFENCE CASES’ published on the website of the Directorate-General for Trade: http://trade.ec.europa.eu/doclib/docs/2011/june/tradoc_148003.pdf. The interested parties must indicate their name, address, telephone and a valid e-mail address and they should ensure that the provided e-mail address is a functioning official business e-mail which is checked on a daily basis. Once contact details are provided, the Commission will communicate with interested parties by e-mail only, unless they explicitly request to receive all documents from the Commission by another means of communication or unless the nature of the document to be sent requires the use of a registered mail. For further rules and information concerning correspondence with the Commission including principles that apply to submissions by e-mail, interested parties should consult the communication instructions for interested parties referred to above.

                                 Commission address for correspondence:

                                 European Commission

                                 Directorate-General for Trade

                                 Directorate H Office: CHAR 04/039 1049 Brussels

                                 BELGIUM

                                 E-mail: TRADE-R563-BICYCLES-CIRC@ec.europa.eu

               2.6.   Non-cooperation

                     (25)

                     In cases where any interested party refuses access to or does not provide the necessary information within the time limits, or significantly impedes the investigation, findings, affirmative or negative, may be made on the basis of facts available, in accordance with Article 18 of the basic Regulation.

                     (26)

                     Where it is found that any interested party has supplied false or misleading information, the information may be disregarded and use may be made of facts available.

                     (27)

                     If an interested party does not cooperate or cooperates only partially and findings are therefore based on facts available in accordance with Article 18 of the basic Regulation, the result may be less favourable to that party than if it had cooperated.

                     (28)

                     Failure to give a computerised response will not be deemed to constitute non-cooperation, provided that the interested party shows that presenting the response as requested would result in an unreasonable extra burden or unreasonable additional cost. The interested party should immediately contact the Commission.

               2.7.   Hearing Officer

                     (29)

                     Interested parties may request the intervention of the Hearing Officer in trade proceedings. The Hearing Officer acts as an interface between the interested parties and the Commission investigation services. The Hearing Officer reviews requests for access to the file, disputes regarding the confidentiality of documents, requests for extension of time limits and requests by third parties to be heard. The Hearing Officer may organise a hearing with an individual interested party and mediate to ensure that the interested parties’ rights of defence are being fully exercised.

                     (30)

                     A request for a hearing with the Hearing Officer should be made in writing and should specify the reasons for the request. The Hearing Officer will examine the reasons for the requests. These hearings should only take place if the issues have not been settled with the Commission services in due course.

                     (31)

                     Any request must be submitted in good time and expeditiously so as not to jeopardise the orderly conduct of proceedings. To that effect, interested parties should request the intervention of the Hearing Officer at the earliest possible time following the occurrence of the event justifying such intervention. Where hearing requests are submitted outside the relevant timeframes, the Hearing Officer will also examine the reasons for such late requests, the nature of the issues raised and the impact of those issues on the rights of defence, having due regard to the interests of good administration and the timely completion of the investigation.

                     (32)

                     For further information and contact details interested parties may consult the Hearing Officer’s web pages on DG Trade’s website: http://ec.europa.eu/trade/trade-policy-and-you/contacts/hearing-officer/

               2.8.   Processing of personal data

                     (33)

                     Any personal data collected in this investigation will be treated in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (10).

                     (34)

                     A data protection notice that informs all individuals of the processing of personal data in the framework of Commission’s trade defence activities is available on DG Trade’s website: https://trade.ec.europa.eu/doclib/docs/2019/april/tradoc_157872.pdf

               2.9.   Instructions to customs authorities

                     (35)

                     National customs authorities are instructed to await the publication of the outcome of the reopening investigation before deciding on any claims for repayment and remission of the duties concerned by this Regulation. Such publication should normally occur within nine months from the date of publication of this Regulation.

               2.10.   Disclosure

                     (36)

                     Interested parties will be subsequently informed of the essential facts and considerations on the basis of which it is intended to implement the judgment and will be given an opportunity to comment,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The Commission reopens the anti-circumvention investigation concerning imports of bicycles and other cycles (including delivery tricycles, but excluding unicycles), not motorised, currently falling within CN codes ex 8712 00 30 and ex 8712 00 70 (TARIC codes 8712003010 and 8712007091), consigned from Indonesia, Malaysia, Sri Lanka and Tunisia, whether declared as originating in Indonesia, Malaysia, Sri Lanka and Tunisia or not, that led to the adoption of Council Implementing Regulation (EU) No 501/2013 of 29 May 2013 extending the definitive anti-dumping duty imposed by Council Implementing Regulation (EU) No 990/2011.

            Article 2

               1.   The customs authorities of the Member States shall, pursuant to Article 13(3) and Article 14(5) of the basic Regulation, take the appropriate steps to register the imports into the Union identified in Article 1 of this Regulation.

               2.   Registration shall expire nine months following the date of entry into force of this Regulation.

            Article 3
            National customs authorities shall await the publication of the outcome of the reopening investigation before deciding on any claims for repayment and remission of the duties concerned by this Regulation.

            Article 4
            This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 29 November 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 176, 30.6.2016, p. 21.

            (2)  Commission Regulation (EU) No 875/2012 of 25 September 2012 initiating an investigation concerning the possible circumvention of anti-dumping measures imposed by Council Implementing Regulation (EU) No 990/2011 on imports of bicycles originating in the People’s Republic of China by imports of bicycles consigned from Indonesia, Malaysia, Sri Lanka and Tunisia, whether declared as originating in Indonesia, Malaysia, Sri Lanka and Tunisia or not, and making such imports subject to registration (OJ L 258, 26.9.2012, p. 21).

            (3)  Council Implementing Regulation (EU) No 501/2013 of 29 May 2013 extending the definitive anti-dumping duty imposed by Implementing Regulation (EU) No 990/2011 on imports of bicycles originating in the People’s Republic of China to imports of bicycles consigned from Indonesia, Malaysia, Sri Lanka and Tunisia, whether declared as originating in Indonesia, Malaysia, Sri Lanka and Tunisia or not (OJ L 153, 5.6.2013, p. 1).

            (4)  Joined Cases C-248/15P (appeal submitted by the Union industry), C-254/15P (appeal submitted by the European Commission) and C-260/15 P (appeal submitted by the Council of the European Union).

            (5)  Judgment of the Court of 15 March 2018, Case C-256/16 Deichmann, ECLI:EU:C:2018:187, paragraph 73; see also judgment of the Court of 19 June 2019, Case C-612/16 P&J Clark International, ECLI:EU:C:2019:508, paragraph 43

            (6)  Ibid, paragraph 74; see also judgment of the Court of 19 June 2019, Case C-612/16 P&J Clark International, ECLI:EU:C:2019:508, paragraph 43.

            (7)  Judgment of 3 October 2000, Case C-458/98 P Industrie des Poudres Sphériques v Council, ECLI:EU:C:2000:531, paragraph 80 to 85.

            (8)  A ‘Limited’ document is a document which is considered confidential pursuant to Article 19 of Regulation (EU) 2016/1036 of the European Parliament and of the Council (OJ L 176, 30.6.2016, p. 21) and Article 6 of the WTO Agreement on Implementation of Article VI of the GATT 1994 (Anti-Dumping Agreement). It is also a document protected pursuant to Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council (OJ L 145, 31.5.2001, p. 43).

            (9)  In order to have access to TRON.tdi, interested parties need an EU Login account. Full instructions on how to register and use TRON.tdi are available on https://webgate.ec.europa.eu/tron/resources/documents/gettingStarted.pdf

            (10)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).


title: Commission Implementing Regulation (EU) 2019/2029 of 29 November 2019 granting a Union authorisation for the single biocidal product CVAS Disinfectant product based on Propan-2-ol (Text with EEA relevance)

text:
                  4.12.2019

                  EN

                  Official Journal of the European Union

                  L 313/41

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/2029
         of 29 November 2019
         granting a Union authorisation for the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph of Article 44(5) thereof,
         Whereas:

                     (1)

                     On 29 June 2016, SCC GmbH (on behalf of CVAS Development GmbH), submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a single biocidal product named ‘CVAS Disinfectant product based on Propan-2-ol’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-DH025620-60 in the Register for Biocidal Products.

                     (2)

                     ‘CVAS Disinfectant product based on Propan-2-ol’ contains propan-2-ol, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.

                     (3)

                     On 17 August 2018, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

                     (4)

                     On 25 March 2019, the Agency submitted to the Commission an opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘CVAS Disinfectant product based on Propan-2-ol’ and the final assessment report on the single biocidal product in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concludes that ‘CVAS Disinfectant product based on Propan-2-ol’ is a ‘single biocidal product’ within the meaning of Article 3(1)(r) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.

                     (5)

                     On 3 June 2019, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

                     (6)

                     The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘CVAS Disinfectant product based on Propan-2-ol’.

                     (7)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

               HAS ADOPTED THIS REGULATION:

            Article 1
            A Union authorisation with authorisation number EU-0020461-0000 is granted to CVAS Development GmbH for the making available on the market and use of the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’, in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 24 December 2019 until 30 November 2029.

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 29 November 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 167, 27.6.2012, p. 1.

            (2)  ECHA opinion of 28 February 2019 on the Union authorisation of ‘CVAS Disinfectant product based on Propan-2-ol’ (ECHA/BPC/222/2019).

            ANNEX

               Summary of product characteristics for a biocidal product

            CVAS Disinfectant product based on Propan-2-ol
            Product type 2 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
            Product type 4 — Food and feed area (Disinfectants)
            Authorisation number: EU-0020461-0000
            R4BP asset number: EU-0020461-0000
            1.   ADMINISTRATIVE INFORMATION
            1.1.   Trade name(s) of the product

                        Trade name(s)

                        CVAS Disinfectant product based on Propan-2-ol
                        calgonit DS 622
                        R 3000 SCHNELLDESINFEKTION
                        IPADES 70
                        Alpha Septin
                        Blu-Sept
                        Disinfect home
                        Schnell Des
                        Disinfect Rapid
                        Bakt-Ex Pur
                        Bakt-Ex Rapid
                        ROTIE-DES quick
                        Bactazol I
                        Dezynfektator
                        EOSSAN-Desinfektionsspray-Fluid
                        FS-7-Spray
                        Gartengeräte Hygiene Spray
                        NeudoClean Hygiene Spray

                  1.2.   Authorisation holder

                        Name and address of the authorisation holder

                        Name

                        CVAS Development GmbH

                        Address

                        Dr Albert Reimann Str. 16a, 68526, Ladenburg, Germany

                        Authorisation number

                        EU-0020461-0000

                           R4BP asset number

                        EU-0020461-0000

                        Date of the authorisation

                        24 December 2019

                        Expiry date of the authorisation

                        30 November 2029

                  1.3.   Manufacturer(s) of the product

                        Name of manufacturer

                        Brenntag GmbH

                        Address of manufacturer

                        Messeallee 11, 45131 Essen, Germany

                        Location of manufacturing sites

                        Am Nordseekai 22, 73207 Plochingen Germany

                        Name of manufacturer

                        Calvatis GmbH

                        Address of manufacturer

                        Dr Albert Reimann Str. 16a, 68526 Ladenburg Germany

                        Location of manufacturing sites

                        Dr Albert Reimann Str. 16a, 68526 Ladenburg Germany

                        Name of manufacturer

                        Arthur Schopf Hygiene GmbH & Co. KG

                        Address of manufacturer

                        Pfaffensteinstr. 1, 83115 Neubeuern Germany

                        Location of manufacturing sites

                        Pfaffensteinstr. 1, 83115 Neubeuern Germany

                  1.4.   Manufacturer(s) of the active substance(s)

                        Active substance

                        Propan-2-ol

                        Name of manufacturer

                        Shell Nederland Raffinaderij B.V.

                        Address of manufacturer

                        Vondelingenweg 601, 3196 KK, Vodelingenenplaat Rotterdam Netherlands

                        Location of manufacturing sites

                        Vondelingenweg 601, 3196 KK, Vodelingenenplaat Rotterdam Netherlands

                        Active substance

                        Propan-2-ol

                        Name of manufacturer

                        ExxonMobil

                        Address of manufacturer

                        4999 Scenic Highway, LA 70897 Baton Rouge, Louisana United States

                        Location of manufacturing sites

                        4999 Scenic Highway, LA 70897 Baton Rouge, Louisana United States

                        Active substance

                        Propan-2-ol

                        Name of manufacturer

                        INEOS Solvents Germany GmbH

                        Address of manufacturer

                        Römerstraße 733, 47443 Moers Germany

                        Location of manufacturing sites

                        Römerstraße 733, 47443 Moers Germany

                  2.   PRODUCT COMPOSITION AND FORMULATION
            2.1.   Qualitative and quantitative information on the composition of the product

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        61,25

                  2.2.   Type of formulation

            Any other liquid (ready-to-use)
            3.   HAZARD AND PRECAUTIONARY STATEMENTS

                        Hazard statements

                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        If medical advice is needed, have product container or label at hand.
                        Keep out of reach of children.
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Avoid breathing vapours.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents/container in accordance with local regulations.
                        Wash hands thoroughly after handling.
                        IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                        In case of fire: Use alcohol-resistant foam to extinguish.

                  4.   AUTHORISED USE(S)
            4.1.   Use description

               Table 1

               Use # 1 — Disinfection of small surfaces by non-professional users (product-type 2)

                        Product type

                        PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts

                        Field(s) of use

                        Indoor
                        Disinfection of non-porous surfaces in domestic areas.

                        Application method(s)

                        Spraying
                        Spraying with trigger sprayer or pump spray
                        Spraying and wiping
                        Spraying with trigger sprayer or pump spray and wiping
                        Pouring and wiping

                        Application rate(s) and frequency

                        40-50 mL/m2

                        Category(ies) of users

                        General public (non-professional)

                        Pack sizes and packaging material

                                    1.

                                    Bottle: High-density polyethylene (HDPE), 250 - 1 000  mL

                                    2.

                                    Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000  mL

                  4.1.1.   Use-specific instructions for use

            The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label:

                        •

                        Trigger spray: Apply 20 spray strokes per 0,5 m2.

                        •

                        Pump spray: Apply 3 jets per 100 cm2.

                        •

                        Bottle: Apply one measuring cup per m2.

                  4.1.2.   Use-specific risk mitigation measures

            See section 5.2.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See section 5.3.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See section 5.4.
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See section 5.5.
            4.2.   Use description

               Table 2

               Use # 2 — Disinfection of small surfaces by professional users (product-type 2)

                        Product type

                        PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts

                        Field(s) of use

                        Indoor
                        Disinfection of non-porous surfaces in industry, small enterprises, institutions and domestic areas.

                        Application method(s)

                        Spraying
                        Spraying with trigger sprayer or pump spray
                        Spraying and wiping
                        Spraying with trigger sprayer or pump spray and wiping
                        Pouring and wiping

                        Application rate(s) and frequency

                        40-50 mL/m2

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                                    1.

                                    Bottle: HDPE, 250 - 1 000  mL

                                    2.

                                    Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000  mL

                                    3.

                                    Intermediate bulk containers (IBC): HDPE, 720 L

                                    4.

                                    Drum: Steel, zinc coated and painted, 200 - 220 L

                                    5.

                                    Canister: HDPE, 5 - 50 L

                  4.2.1.   Use-specific instructions for use

            See section 5.1.
            4.2.2.   Use-specific risk mitigation measures

                        1.

                        The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and/or organisational measures: The use of eye protection during handling of the product is recommended.

                        2.

                        The product must only be applied for disinfection of small surfaces.

                  4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See section 5.3.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See section 5.4.
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See section 5.5.
            4.3.   Use description

               Table 3

               Use # 3 — Disinfection of small surfaces by non-professional users (product-type 4)

                        Product type

                        PT04 — Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts

                        Field(s) of use

                        Indoor
                        Disinfection of non-porous surfaces in kitchens.
                        Disinfection of gardening equipment for human hygiene purpose only.

                        Application method(s)

                        Spraying
                        Spraying with trigger sprayer or pump spray
                        Spraying and wiping
                        Spraying with trigger sprayer or pump spray and wiping
                        Pouring and wiping

                        Application rate(s) and frequency

                        40-50 mL/m2

                        Category(ies) of users

                        General public (non-professional)

                        Pack sizes and packaging material

                                    1.

                                    Bottle: HDPE, 250 - 1 000  mL

                                    2.

                                    Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000  mL

                  4.3.1.   Use-specific instructions for use

                        1.

                        For use at room temperature (20 ± 2 °C).

                        2.

                        The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label:

                                    •

                                    Trigger spray: Apply 20 spray strokes per 0,5 m2.

                                    •

                                    Pump spray: Apply 3 jets per 100 cm2.

                                    •

                                    Bottle: Apply one measuring cup per m2

                        3.

                        Disinfection of gardening equipment for human hygiene purpose only.

                        4.

                        Disinfect gardening equipment only indoors.

                  4.3.2.   Use-specific risk mitigation measures

            See section 5.2.
            4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See section 5.3.
            4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See section 5.4.
            4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See section 5.5.
            4.4.   Use description

               Table 4

               Use # 4 — Disinfection of small surfaces by professional users (product-type 4)

                        Product type

                        PT04 — Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts

                        Field(s) of use

                        Indoor
                        Disinfection of non-porous surfaces in canteens or kitchens, food processing industry (including breweries).
                        Disinfection of gardening equipment for human hygiene purpose only.

                        Application method(s)

                        Spraying
                        Spraying with trigger sprayer or pump spray
                        Spraying and wiping
                        Spraying with trigger sprayer or pump spray and wiping
                        Pouring and wiping

                        Application rate(s) and frequency

                        40-50 mL/m2

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                                    1.

                                    Bottle: HDPE, 250 - 1 000  mL

                                    2.

                                    Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000  mL

                                    3.

                                    IBC: HDPE, 720 L

                                    4.

                                    Drum: Steel, zinc coated and painted, 200 - 220 L

                                    5.

                                    Canister: HDPE, 5 - 50 L

                  4.4.1.   Use-specific instructions for use

                        1.

                        For use at room temperature (20 ± 2 °C).

                        2.

                        Disinfection of gardening equipment for human hygiene purpose only.

                        3.

                        Disinfect gardening equipment only indoors.

                  4.4.2.   Use-specific risk mitigation measures

                        1.

                        Provide adequate ventilation (industrial ventilation or keeping windows and doors open).

                        2.

                        The product must only be applied for disinfection of small surfaces.

                        3.

                        The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and/or organisational measures: The use of eye protection during handling of the product is recommended.

                  4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See section 5.3.
            4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See section 5.4.
            4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See section 5.5.
            5.   GENERAL DIRECTIONS FOR USE (1)

            5.1.   Instructions for use

                        1.

                        Clean surfaces before use.

                        2.

                        Apply the product to the surface undiluted by spraying. Make sure to wet surfaces completely. Allow to take effect for at least 15 minutes.

                        3.

                        Apply the product to the surface undiluted by spraying/pouring the product and wiping of the surface afterwards. Make sure to wet surfaces completely. Allow to take effect for at least 5 minutes.

                        4.

                        Do not apply more than 50 mL/m2.

                        5.

                        Used wipes must be disposed in a closed container.

                        6.

                        For non-professional users only: Do not use more than 4 applications per day.

                  5.2.   Risk mitigation measures

                        1.

                        Keep out of reach of children and pets.

                        2.

                        Avoid contact with eyes.

                        3.

                        Do not apply in the presence of small children.

                        4.

                        Keep children and pets away from rooms, where disinfection is taking place. Provide adequate ventilation before children enter treated rooms.

                        5.

                        For refilling a funnel must be applied.

                  5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            First aid:

                        1.

                        IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.

                        2.

                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.

                        3.

                        Call a POISON CENTER or doctor/physician if you feel unwell.

                        4.

                        If eye irritation persists, get medical advice.

                  5.4.   Instructions for safe disposal of the product and its packaging

            At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store cool (not above 30 °C) and protect from frost.
            Shelf-life: 24 months.
            6.   OTHER INFORMATION
            Please be aware of the European reference value of 129,28 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the product.

               (1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.