Audit process and levels of assurance
1. Voluntary schemes shall require that economic operators successfully pass an initial audit before allowing them to participate in the scheme. The initial audit of a new scheme participant or a re-certification of existing scheme participant under a revised regulatory framework shall always be on-site and shall as a minimum provide reasonable assurance on the effectiveness of its internal processes. Depending on the risk profile of the economic operator, a limited assurance level can be applied on the veracity of its statements. On the basis of the results of the initial audit, those economic operators who are considered low risk may be subject to subsequent limited assurance audits.
2. Voluntary schemes may authorise a certification body to perform the verification of compliance with different certification frameworks during the same auditing process, as long as the certification body certifies that economic operators satisfy the requirements in line with Article 1. Voluntary schemes that allow a certificate duration longer than one year shall ensure the carrying out of an annual surveillance audit of all economic operators participating in the scheme. However, in the case of group audits, the annual audit may cover a sample of the group members in accordance with Article 12. The frequency of surveillance audits shall be increased on the basis of the level of overall risk related to the profile of the economic operator, the supply chain and the results of previous audits. The technical reviewer shall be responsible for validating the results of surveillance audits.
Voluntary schemes shall establish detailed procedures setting out how audits are planned and conducted and how audit reports are drawn up. Voluntary schemes shall ensure that certification bodies conduct audits in accordance with ISO 19011 or the equivalent. Voluntary schemes shall also ensure an efficient and timely exchange of audit information between them to support the effective preparation and conduct of the audit. The audit shall include at least the following elements:
(a)
identification of the activities undertaken by the economic operator which are relevant to the scheme’s criteria;
(b)
identification of the relevant systems of the economic operator and its overall organisation with respect to the scheme’s criteria and checks of the effective implementation of relevant control systems;
(c)
analysis of the risks which could lead to a material misstatement, based on the auditor’s professional knowledge and the information submitted by the economic operator. That analysis shall take into consideration the overall risk profile of the activities, depending on the level of risk of the economic operator and the supply chain, above all at the immediately upstream and downstream stages, for example, for economic operators that handle material listed in Annex IX. The audit intensity or scope, or both, shall be adapted to the level of overall risk identified, also based on plausibility checks of the production capacity of a plant and the declared quantities of produced fuels;
(d)
a verification plan which corresponds to the risk analysis and the scope and complexity of the economic operator’s activities, and which defines the sampling methods to be used with respect to that operator’s activities;
(e)
implementation of the verification plan by gathering evidence in accordance with the defined sampling methods, plus all relevant additional evidence, upon which the verifier’s conclusion will be based;
(f)
a request to the operator for the provision of any missing elements of audit trails, an explanation of variations, or the revision of claims or calculations, before reaching a final verification conclusion;
(g)
verification of the accuracy of data recorded by the economic operators or their representatives in the Union database.
3. Non-conformities identified during an audit shall be classified as critical, major and minor in accordance with the second, third and fourth subparagraphs.
The intentional violation of a voluntary scheme’s standards such as fraud, irreversible non-conformity, or a violation that jeopardies the integrity of the voluntary scheme shall be considered to be a critical non-conformity. Critical non-conformities shall include, but are not limited to, the following:
(a)
non-compliance with a mandatory requirement of Directive (EU) 2018/2001, such as land conversion which contravenes Article 29(3), (4) and (5) of that Directive;
(b)
fraudulent issuance of a proof of sustainability or self-declarations, for example, intentional duplication of a proof of sustainability to seek financial benefit;
(c)
deliberate misstatement of raw material description, falsification of GHG values or input data as well as the deliberate production of wastes or residues, for example, the deliberate modification of a production process to produce additional residue material, or the deliberate contamination of a material with the intention of classifying it as a waste.
Failure to comply with a mandatory requirement of Directive (EU) 2018/2001, where the non-conformity is potentially reversible, repeated and reveals systematic problems, or aspects that alone, or in combination with further non-conformities, may result in a fundamental system failure, shall be considered to be a major non-conformity. Major non-conformities shall include, but are not limited to, the following:
(a)
systematic problems with mass balance or GHG data reported for example, incorrect documentation is identified in more than 10 % of the claims included in the representative sample;
(b)
the omission of an economic operator to declare its participation in other voluntary schemes during the certification process;
(c)
failure to provide relevant information to auditors for example, mass balance data and audit reports.
A non-conformity that has a limited impact, constitutes an isolated or temporary lapse, is not systematic and does not result in a fundamental failure if not corrected, shall be considered to be a minor non-conformity.
4. The consequences of non-conformities for economic operators shall be the following:
(a)
in the case of critical non-conformities, economic operators applying for certification shall not be issued a certificate. Economic operators may re-apply for certification after the lapse of a fixed period of time, determined by the voluntary scheme. Critical non-conformities identified during surveillance or re-certification audits, or through a voluntary scheme’s internal monitoring or complaints process, shall lead to the immediate withdrawal of the economic operator’s certificate;
(b)
in the case of major non-conformities, economic operators applying for certification shall not be issued a certificate. Major non-conformities identified during surveillance or re-certification audits, or through a voluntary scheme’s internal monitoring or complaints process, shall lead to the immediate suspension of the economic operator’s certificate. Where economic operators do not provide a remedy for any major non-conformities within 90 days from notification, the certificate shall be withdrawn;
(c)
in the case of minor non-conformities, voluntary schemes may define the time period for their resolution, not exceeding 12 months from their notification and the date of next surveillance or re-certification audit.
5. Voluntary schemes shall only certify economic operators where they comply with all the following requirements:
(a)
have a documentation management system;
(b)
have an auditable system for safekeeping and reviewing all evidence related to the claims they make or rely on;
(c)
keep all evidence necessary to comply with this Regulation and Directive (EU) 2018/2001 for a minimum of 5 years, or longer where it is required by the relevant national authority;
(d)
accept responsibility for preparing any information related to the auditing of such evidence.
6. The audit reports and summary audit reports or certificates drawn up or issued by a certification body within the framework of a voluntary scheme shall at least include the elements set out in Annex II.
Auditor competence
1. A certification body performing audits on behalf of a voluntary scheme shall be accredited to ISO 17065, and to ISO 14065 where it performs audits on actual GHG values.
Certification bodies shall also be accredited by a national accreditation body and in accordance with Regulation (EC) No 765/2008 or recognised by a competent authority to cover the scope of Directive (EU) 2018/2001 or the specific scope of the voluntary scheme. Where no use of such accreditation or recognition is made, Member States may allow voluntary schemes to use a system of independent oversight that covers the scope of Directive (EU) 2018/2001 or the specific scope of the voluntary scheme, for the territory of that Member State. The Commission shall review the effectiveness of the systems described in this paragraph with regard to their suitability to ensure adequate surveillance and issue guidance if appropriate.
The certification body shall select and appoint the audit team in accordance with ISO 19011, taking into account the competence needed to achieve the objectives of the audit.
2. The audit team shall have the competence, experience and the generic and specific skills necessary for conducting the audit taking into account the scope of the audit. Where there is only one auditor, the auditor shall also have the competence to perform the duties of an audit team leader applicable for that audit. The certification body shall ensure that the certification decision is taken by a technical reviewer that was not part of the audit team.
3. Auditors shall:
(a)
be independent of the activity being audited, except for audits concerning Article 29(6), point (a), and Article 29(7), point (a) of Directive (EU) 2018/2001, for which first or second party auditing may be carried out up to the first gathering point;
(b)
be free from conflict of interest;
(c)
have the specific skills necessary for conducting the audit related to the scheme’s criteria, including:
(i)
for land-use criteria laid down in Article 29, points (2) to (9) of Directive (EU) 2018/2001 as well as the low ILUC risk certification methodology set in Chapter V and Annex VIII of this implementing regulation: experience in agriculture, agronomy, ecology, natural science, forestry, silviculture or a related field, including specific technical skills needed to verify compliance with the highly biodiverse grasslands and highly biodiverse forest criteria;
(ii)
for GHG emissions saving criteria laid down in Article 29(10) of Directive (EU) 2018/2001 or when determining the GHG emissions of recycled carbon fuels and renewable fuels of non-biological origin in accordance with the methodology set out in Article 28(5) of Directive (EU) 2018/2001: a minimum of 2 years’ experience in fuel life-cycle assessment, and specific experience in auditing GHG emission calculations in accordance with the methodology set out in Annexes V and VI to Directive (EU) 2018/2001, that is relevant for the type of audits to be conducted by the individual auditor. Depending on the specific scope of the audit, that experience shall be complemented by experience in agriculture, agronomy, ecology, forestry, natural science, silviculture, engineering, energy management or a related field. Where the scope of the audit includes verifying soil organic carbon levels, for the purpose of applying the emission saving credit for soil carbon accumulation, technical knowledge on soil science shall also be required;
(iii)
for the chain of custody criteria laid down in Article 30, points (1) to (2) of Directive (EU) 2018/2001: experience in mass balance systems, supply chain logistics, bookkeeping, traceability, and data handling or a related field;
(iv)
for group auditing: experience in conducting group audits.
4. Voluntary schemes shall set up training courses for auditors, covering all aspects relevant to the scope of the scheme. The courses shall include an examination to demonstrate the participants’ compliance with the training requirements in the technical area or areas in which they are active. Auditors shall participate in the training courses, before performing audits on behalf of the voluntary scheme.
5. Auditors shall undertake refresher training courses on a regular basis. Voluntary schemes shall implement a system to monitor the training status of active scheme auditors. Voluntary schemes shall also provide guidance to certification bodies, as required, on aspects that are relevant to the certification process. That guidance may include updates to the regulatory framework or relevant findings from the voluntary scheme’s internal monitoring process.
Group auditing
1. Voluntary schemes may perform group auditing only in the following cases:
(a)
for producers of raw material, in particular smallholders, producer organisations and cooperatives as well as waste collectors;
(b)
for compliance with the scheme’s land-related criteria, where the areas concerned are in proximity and have similar characteristics, such as climatic or soil conditions;
(c)
for the purpose of calculating GHG savings, where the units have similar production systems and types of crops.
Economic operators included in a group audit shall designate a group manager. First gathering points, producer organisations or cooperatives, may also act as group managers, representing the economic operators included in the group audit.
2. Group auditing may carry out verification for all units concerned on the basis of sample of units. Voluntary schemes shall set out guidelines on the implementation of a group auditing approach, including at least the following elements:
(a)
role of the group manager, covering specifications for the internal management system and internal group inspection procedures;
(b)
determination of sample size.
3. A sample consisting of a number of group members equivalent to the square root of the total number of group members shall be audited individually at least once a year. That number shall be increased in the event of a higher level of risk. Voluntary schemes shall establish criteria for determining the general level of risk in the areas and the consequences of that level of risk for the auditing approach. The sample shall be representative of the whole group and determined using a combination of risk and random selection. Random selection shall represent at least 25 % of the sample. The producer of raw material selected for the audit shall vary from year to year.
4. Group auditing shall be performed on-site, unless it is considered that desk audits are able to provide the same level of assurance as an on-site audit. Voluntary schemes shall set out the evidence required to allow for desk audits. Self-declarations from economic operators shall not be considered to be sufficient evidence. Audits of the group manager shall always be conducted on-site.
5. Critical or major non-compliance of individual group members identified during an audit shall be addressed according to process set out under paragraph 4 (a) and (b) of Article 10, as applicable. If a critical or major non-compliance is identified in the whole initial group sample, then an additional sample of group members of the same size shall also be audited. Systemic non-compliance of the majority of group members across the whole sample shall lead to the suspension or withdrawal of the whole group certification, as applicable.
Auditing of waste and residues
1. Voluntary schemes and the certification bodies working on their behalf shall apply the requirements for the verification of the supply chain of biofuels and bioliquids made from waste and residues set out in paragraphs 2 to 7, and for biomass fuels the requirements set out in paragraphs 2 to 5.
2. The whole supply chain shall be covered starting from its origin, that is to say, the economic operator where the waste or residue material arises;
3. All economic operators shall be audited individually. However, group auditing approaches may be carried out at the origin of the supply chain, for example, restaurants and waste or residue producers;
4. The frequency and intensity of the auditing procedure shall reflect the overall level of risk. Voluntary schemes shall define clear rules, commensurate to the level of specific risk associated with the type of residues or waste. For biofuels and bioliquids, points of origin supplying five or more tonnes per month of waste or residue listed in part A and B of Annex IX to Directive (EU) 2018/2001 shall be subject to an on-site audit. The on-side audit may be based on a sample where a group auditing approach is taken.
5. Collection points shall be required to submit a list of all points of origin that have signed a self-declaration to the auditor prior to the audit of the collection point. The amount of waste generated monthly or annually shall be clearly stated on the self-declaration. Evidence or documents for all individual deliveries shall be available at the collection point and verified by the auditor, including waste disposal agreement, delivery slips and self-declarations;
6. The auditor shall verify the existence of a number of points of origin equivalent to at least the square root of all the points of origin on the list. The verification may be performed remotely, unless there is doubt concerning the existence of the point of origin or where it meets the criteria for on-site audit pursuant to point (4). Auditors shall check deliveries of sustainable material to downstream recipients by verifying the copies of the sustainability declaration issued by the collecting point to recipients of those deliveries, based on a random and risk-based sample;
7. The certification body shall carry out a mandatory surveillance audit within 6 months after the first certification. For collection points and traders that deal with both waste and residues and with virgin materials such as vegetable oils, an additional surveillance audit shall be conducted 3 months after the first certification audit, covering the first mass balance period. Where a collection point has multiple storage sites, the auditor shall audit the mass balance of every storage site.
8. If there are reasonable doubts about the nature of the declared waste and residues, the auditor is authorised to take samples and to have them analysed by an independent laboratory.
Auditing of actual GHG emission calculations
1. Voluntary schemes shall require economic operators to provide auditors with all the relevant and up to date information concerning the calculation of actual GHG emissions, in advance of the planned audit. That information shall include input data and any other relevant evidence, information on the emission and conversion factors and standard values applied and their reference sources, GHG emission calculations and evidence relating to the application of GHG emission saving credits.
2. The auditor shall record the emissions occurring at the audited site in the audit report. For the processing of final biofuels, the auditor shall record the emissions after allocation and the achieved savings. Where the emissions deviate significantly from typical values or calculated actual values of emissions savings are abnormally high, reasons shall be given for the deviations in the report. Voluntary schemes shall establish procedures requiring certification bodies to immediately inform them of such deviations.
3. Auditors shall verify that the estimate of emissions saving from capture and replacement of CO 2 is limited to emissions avoided through the capture of CO 2 of which the carbon originates from biomass and which is used to replace fossil-derived CO 2 . That verification requires access to the following information:
(a)
the purpose for which the captured CO 2 is used;
(b)
the origin of the CO 2 that is replaced;
(c)
the origin of the CO 2 that is captured;
(d)
information on emissions due to capturing and processing of CO 2 .
For the purposes of point (b), economic operators using captured CO 2 may state how the CO 2 that is replaced was previously generated and declare, in writing, that emissions equivalent to that quantity are avoided as a consequence of the replacement. That evidence shall be considered sufficient to verify compliance with the requirements of Directive (EU) 2018/2001 and the avoidance of emissions.
4. Economic operators may only make actual GHG values claims after their capability to conduct actual value calculations has been verified by an audit.
5. Upon request, voluntary schemes shall provide access to actual GHG calculations certified under their voluntary scheme together with the respective audit reports to the Commission and the national authorities responsible for supervision of the certification bodies.
Audits of mass balance systems
Voluntary schemes shall ensure that economic operators provide auditors with all mass balance data in advance of the audit.
During the initial audit, carried out before an economic operator is allowed to participate in a scheme, the auditor shall check the existence and functioning of the mass balance system.
During subsequent annual audits, the auditor shall check at least the following elements:
(a)
list of all sites, that are under the scope of certification. Each site shall have its own mass balance records;
(b)
list of all inputs per site and the description of material handled and details of all suppliers;
(c)
list of all outputs per site and the description of material handled and details of all customers;
(d)
conversion factors applied, in particular in the case of installations processing waste or residues to ensure that the process is not modified to produce more waste or residue material;
(e)
any discrepancies between book keeping system and inputs, outputs and balances;
(f)
allocation of sustainability characteristics;
(g)
equivalence of the sustainability data and the physical stock at the end of the mass balance period.
Auditing of natural and non-natural highly-biodiverse grassland
1. Auditors verifying whether land is highly biodiverse grassland as referred to in Article 29(3), point (d), of Directive (EU) 2018/2001 shall verify whether the land is or has been highly biodiverse grassland at any moment since January 2008. In their system documents, voluntary schemes shall inform the economic operators about the type of evidence, which their certification bodies may accept to prove historical area status since January 2008.
2. Where land remains grassland, or would have remained grassland in the absence of human intervention, and is located in any of the geographic ranges listed in Regulation (EU) No 1307/2014, it shall be considered as natural, highly biodiverse grassland.
3. For land that is located outside the areas referred to in paragraph 2, the auditor shall assess whether the grassland maintains, or would have maintained in the absence of human intervention, the natural species composition and ecological characteristics and processes. Where that is the case, the land shall be considered as being, or having been, natural, highly biodiverse grassland. Where grassland has already been converted to arable land and it is not possible to assess the characteristics of the land itself through information available from the national competent authorities or satellite imagery, the auditor shall consider such land as not having been highly biodiverse grassland at the moment of conversion.
4. Where the land ceased, or would have ceased in the absence of human intervention, to be grassland, is species-rich and not degraded and has been identified as being highly biodiverse by the relevant competent authority, then the land shall be considered as non-natural, highly biodiverse grassland.
5. Any land that is, or was, non-natural, highly biodiverse grassland in or after January 2008 may be used for fuels production on condition that harvesting of the raw material is necessary to preserve the status of the grassland as highly biodiverse grassland and that current management practices do not present a risk of causing biodiversity decline of the grassland.
Economic operators shall provide evidence that the harvesting of the raw material is necessary to preserve the highly biodiverse grassland status and that management practices do not present a risk of causing biodiversity decline of the grassland.
Where economic operators are unable to provide the evidence referred to in the second subparagraph, they shall provide evidence that they have been granted permission by the relevant competent authority, or designated agency, to harvest the raw material in order to preserve the highly biodiverse grassland status.
The technical assessment of the land shall be conducted by a qualified specialist who is external and independent of the activity being audited and free from conflict of interest, and who may be part of the audit team. The assessment and its result shall be reviewed as part of the audit.
Supervision by the Member States and the Commission
1. Voluntary schemes shall require economic operators participating in the scheme as well as certification bodies conducting audits under the scheme to cooperate with the Commission and the competent authorities of the Member States, including granting access to the premises of economic operators where requested as well as making available to the Commission and the competent authorities of the Member States all information needed to fulfil their tasks under Directive (EU) 2018/2001. For those purposes, certification bodies shall also be required to:
(a)
provide the information needed by Member States to supervise the operation of certification bodies pursuant to Article 30(9) of Directive (EU) 2018/2001;
(b)
provide the information required by the Commission to comply with Article 30(10) of Directive (EU) 2018/2001;
(c)
verify the accuracy of information entered into the Union database or relevant national database pursuant to Article 28(4) of Directive (EU) 2018/2001.
2. In the context of the supervision provided for in Article 30(9) of Directive (EU) 2018/2001, Member States shall establish procedures allowing certification bodies, regardless of whether their head office is located in a Member State or in a third country, to register for supervision and for carrying out the supervision.
3. Member States shall exchange information and share best practices on how to supervise the operation of the certification bodies in the context of a formal cooperation framework. Where certification bodies carry out the certification of raw materials, biofuels, bioliquids, biomass or other fuels in more than one Member State, the Member States concerned shall set up a common framework to supervise such certification bodies, including appointing one Member State as lead audit supervisor.
4. The lead audit supervisor shall be responsible, in cooperation with the other Member States concerned, for consolidating and sharing information about the outcome of the supervision of the certification bodies.
5. Member States shall to the extent possible establish cooperation frameworks with third countries for the supervision of certification bodies auditing in their territories, where relevant, in order to ensure the same level of information flow and the application of audit supervision standards to certification bodies operating in third countries.
6. Where a Member State has reasonable doubts about the ability of a specific certification body, located in the Union or in a third country, to carry out its audit work, it shall share that information with the other Member States, the Commission and the voluntary scheme under which the certification body operates. The voluntary scheme concerned shall immediately investigate the case. Upon completion of its investigation, the voluntary scheme shall inform the Member States and the Commission of the outcome of the investigation and of any corrective actions taken.
7. Economic operators and certification bodies failing or unwilling to comply with the requirements set out in paragraphs 1 to 6 of this Article shall be respectively excluded from participating in and conducting audits under voluntary schemes. Voluntary schemes shall submit annual activity reports to the Commission pursuant to Article 30(5) of Directive (EU) 2018/2001. The structure and content of the annual activity reports provided for in Article 30(5) of Directive (EU) 2018/2001 shall follow the minimum requirements set out in Annex III to this Regulation. The main report shall not contain confidential information and shall be published in full. Data shall be supplied separately in a format to be determined by the Commission.
8. Voluntary schemes shall notify the Commission without delay, about all substantial changes to the content of the scheme that might affect the basis for the recognition of the scheme. Such changes may include any of the following:
(a)
changes to the mandatory sustainability criteria covered by the scheme;
(b)
extension of the scope of the scheme beyond what is described in the Implementing act, recognising the scheme;
(c)
extension of the scope of feedstock or biofuels referred to in the original scheme documents where the risk profile of added feedstock differs, for example, with the inclusion of wastes or residues, or where specific procedures are applied;
(d)
changes to the mass balance rules;
(e)
changes to auditing procedures or requirements for auditors;
(f)
changes in, or extension of the GHG calculation methodology;
(g)
any other change that could be considered to affect the basis for the recognition of the scheme.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.